HealthyPhase 2NCT04535453

A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents

A Phase 2 study testing Ad26.COV2.S in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 13 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ad26.COV2.S
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 635 participants
Where: 13 sitesin 4 countries
Study dates: 28 Aug 2020to 9 Mar 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

For Adults
Participant must have a body mass index (BMI) less than (<) 30.0 kilogram per meter square (kg/m^2)
Participant is 18 to 55 years of age, inclusive, or 65 years of age or older on the day of signing the informed consent form (ICF).
Participant 18 to 55 years of age, inclusive: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19), except for smoking and mild hypertension, which are allowed. Participant 65 years of age and older: In the investigator's clinical judgment, participant must be either in good or stable health. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19, except for smoking and mild hypertension, which are allowed. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participant will be included on the basis of physical examination, medical history, and vital signs
Participant will be included on the basis of physical examination, medical history, and vital signs
All participants of childbearing potential must: a) Have a negative highly sensitive urine pregnancy test at screening, b)Have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration

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Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
For Adolescents:
Participant is 12 to 17 years of age, inclusive, on the day of signing the informed consent form (ICF)
Participants must have signed an ICF (or their legally acceptable representative or parent(s) [preferably both parents if available or as per local requirements] must sign) indicating that they understand the purpose of, and procedures required for, the study, are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures, and are willing (or the parents are willing for their adolescent) to participate in the study. Informed assent must be obtained from adolescents, depending on local regulations and practice
Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe COVID-19

Who cannot join

For Adults
Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius [C] (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
Participant received treatment with immunoglobulins in the 3 months or blood products in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study
Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational Ig or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study For Adolescents

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Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
Participants with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the participant if he/she participates in the study
Participant has a history of Kawasaki disease
Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Trial locations and contacts

13 sites in 4 countries.

Country

City, postcode or hospital

13 sites in 4 countries

United Kingdom4 sites

Alder Hey Hospital
Liverpool, L12 2AP
St George's, University of London
London, SW17 0RE
Royal Manchester Children's Hospital
Manchester, M13 9WL
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD

Other trials in United Kingdom

Germany3 sites

Charité Research Organisation GmbH
Berlin, 10117
CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251
Universitaetsmedizin Rostock
Rostock, 18057

Other trials in Germany

Netherlands3 sites

PRA Health Sciences
Groningen, NZ 9728
Centre for Human Drug Research
Leiden, 2333 CL
UMCU
Utrecht, 3584 CX

Other trials in Netherlands

Spain3 sites

Hosp. Univ. de La Princesa
Madrid, 28006
Hosp. Univ. La Paz
Madrid, 28046
Hosp. Univ. Marques de Valdecilla
Santander, 39008

Other trials in Spain

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive

The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; safety and reactogenicity of Ad26.COV2.S administered IM as a 2-dose or a single-dose schedule in adults (18-65 years or older) and to assess the safety and reactogenicity of Ad26.COV2.S, administered IM as single dose in adolescents (12-17 years) and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart) in adults (18-55 years and 65 years or older).

Read the detailed description

The aim of the COVID-19 vaccine clinical development program is to develop a safe and effective vaccine for the prevention of COVID-19. Currently, there is only limited availability of authorized/licensed vaccines for the prevention of coronavirus disease-2019 (COVID-19). Ad26.COV2.S (also known as Ad26COVS1) is a monovalent vaccine composed of a recombinant, replication incompetent adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus spike (S) protein, which will be assessed in this study. Also, different vaccination intervals and multiple lower dose levels compared to the dose levels in the first in human study (VAC31518COV1001 [NCT04436276]) will be assessed. For adults, the study consists of: screening phase (28 days), vaccination phase (1-3 months) depending on the vaccination interval, and follow-up (12 months). The study duration is approximately 15 months (Groups 1-6, 8, 10 and Group 7 [to participants for whom vaccination 2 was delayed]), 14 months (Group 7), and 16 months (Group 9) in adult groups and approximately 13 months for adolescents group (Groups A to C). The adverse events and other safety assessments including vital signs measurements (heart rate, supine systolic and diastolic blood pressure, respiratory rate, and body temperature), and physical examinations will be assessed during the study.

Note: The Informed Consent Form dated 27-Oct-2020 is final version of the study MASTER ICF, used by local countries to prepare the local language version of the ICF, which have been approved by the Ethics Committees.

And the highlighted text in the ICF document are the guidance for country specific adaptation.

Conditions: Healthy
Being tested: Ad26.COV2.S, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ad26.COV2.SBiological
Also called JNJ-78436735, Ad26COVS1
All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.
PlaceboOther
Adult participants in Groups 4, 5, 6, 8, and 10, and adolescent participants in Group C will receive at least one injection of placebo.

Study groups in NCT04535453
Study group	Role	What they receive
Groups 1-6	Experimental	Participants will receive a 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 57 at different dose levels (Groups 1-3), or a single-dose Ad26.COV2.S vaccination regimen at different dose levels (Groups 4-5), or placebo (Group 6). At unblinded phase, participants in Group 6 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Groups 1-5) or placebo (Group 6). Receives: Biological: Ad26.COV2.S; Other: Placebo
Groups 7-8	Experimental	Participants will receive 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 29 at fixed dose level (Groups 7) or placebo (Groups 8). At unblinded phase, participants in Group 8 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Group 7) or placebo (Group 8). Receives: Biological: Ad26.COV2.S; Other: Placebo
Groups 9-10	Experimental	Participants will receive 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 85 at fixed dose level (Group 9) or placebo (Group 10). At unblinded phase, participants in Group 10 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Group 9) or placebo (Group 10). Receives: Biological: Ad26.COV2.S; Other: Placebo
Groups A-C	Experimental	Participants will receive a single dose Ad26.COV2.S vaccination regimen at Day 1 at fixed dose level (Groups A and B) or placebo (Group C). At approximately 6 months of study participation (unblinded phase), participants in Group C initially receiving placebo will receive Ad26.COV2.S vaccine at a single dose level, at a 56-day interval. Receives: Biological: Ad26.COV2.S; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was less than or equal to the lower limit of quantification (<=LLOQ) and the post-baseline sample was greater than (>) LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (greater than or equal to [>=] 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were 50 percent (%) inhibitory concentration (IC50) of 58 and 12,800 international unit per milliliter (IU/mL) respectively.
Measured: 28 days after Vaccination 2 (Day 85)
Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Measured: 28 days after Vaccination 2 (Day 85)
Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2
Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported.
Measured: 28 days after Vaccination 2 (Day 85)
Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2
Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported.
Measured: 28 days after Vaccination 2 (Day 85)
Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers at 28 Days After Vaccination 1
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Measured: 28 days after Vaccination 1 (Day 29)
Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Measured: 28 days after Vaccination 1 (Day 29)
Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1
Antibody GMTs as measured by VNA at 28 days after vaccination 1 were reported. LLOQ was 58 IU/mL.
Measured: 28 days after Vaccination 1 (Day 29)
Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1
Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 1 were reported. The LLOQ was 50.3 IU/mL.
Measured: 28 days after Vaccination 1 (Day 29)
Adults of Groups 9 and 10: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 2
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Measured: 28 days after Vaccination 2 ( Day 113)
Adults of Groups 9 and 10: Percentage of Participant With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2
Percentage of participant with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Measured: 28 days after Vaccination 2 (Day 113)
Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2
Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported. The LLOQ was 58 IU/mL.
Measured: 28 days after Vaccination 2 (Day 113)
Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2
Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported. The LLOQ was 50.3 IU/mL.
Measured: 28 Days after Vaccination 2 (Day 113)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1
Number of participants with solicited local AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days after vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Measured: 7 days after Vaccination 1 (Day 8)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1
Number of participants with solicited systemic AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).
Measured: 7 days after Vaccination 1 (Day 8)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2
Number of participants with solicited local AEs at 7 days after vaccination 2 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days post vaccination 2 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Measured: 7 days after Vaccination 2 (Day 64 for Groups 1-6; Day 92 for Groups 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2
Number of participants with solicited systemic AEs at 7 days after vaccination 2 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 2 (Day of vaccination 2 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).
Measured: 7 days after Vaccination 2 (Day 64 for Group 1-6; Day 92 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.
Measured: 28 days after Vaccination 1 (Day 29)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.
Measured: 28 days After Vaccination 2 (Day 85 for Groups 1-6; Day 113 for Groups 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measured: Up to 1.5 years
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs)
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Measured: Up to 1.5 years
Adolescents: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 1
Number of participants with solicited local AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days post vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Measured: 7 Days After Vaccination 1 (Day 8)
Adolescents: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 1
Number of participants with solicited systemic AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 1 (Day of vaccination1 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).
Measured: 7 Days After Vaccination 1 (Day 8)
Adolescents: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.
Measured: 28 Days After Vaccination 1 (Day 29)
Adolescents: Number of Participants With SAEs (Inclusive Multisystem Inflammatory Syndrome in Children [MIS-C])
SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
Measured: Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)
Adolescents: Number of Participants With AESIs
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Measured: Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)

Secondary outcomes (22)

Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL, respectively.
Measured: 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9)
Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation
Antibody GMTs as measured by VNA at 7 days after antigen presentation were reported.
Measured: 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9)
Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Measured: 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)
Adults of Group 7: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL. respectively.
Measured: Day 148
Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation
Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported.
Measured: 7 Days after Antigen Presentation (Day 176 for Groups 1-5; Day 204 for Group 9)
Adults of Group 7: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation
Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported.
Measured: Day 148
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation
Number of participants with solicited local AEs at 7 days after antigen presentation were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days after antigen presentation (day of antigen presentation and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Measured: 7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation
Number of participants with solicited systemic AEs at 7 days after antigen presentation were reported. An AE was any untoward medical occurrence in a Participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days after antigen presentation (Day of antigen presentation and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).
Measured: 7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participants diary.
Measured: 28 Days After Antigen Presentation (Day 197 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 225 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation
SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measured: After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Measured: After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10)
Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA
Percentage of participants with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported.
Measured: Days 197 and 393
Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA
Percentage of participants with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported.
Measured: Days 225 and 421
Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins
Percentage of participants with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported.
Measured: Days 197 and 393
Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins
Percentage of participants with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported.
Measured: Days 225 and 421
Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29)
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Measured: 28 Days After Vaccination 1 (Day 29)
Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29)
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Measured: 28 Days After Vaccination 1 (Day 29)
Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1
Antibody GMTs as measured by VNA at 28 days after vaccination 1 (Day 29) were reported. LLOQ was 58 IU/mL
Measured: 28 days After Vaccination 1 (Day 29)
Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1
Antibody GMCs as measured by S-ELISA 28 days after vaccination was reported. LLOQ was 58 IU/mL
Measured: 28 days After Vaccination 1 (Day 29)
Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA
Neutralizing antibody titers to the Wild-type SARS-CoV-2 virus expressing S protein measured by VNA was reported. LLOQ was 58 IU/mL.
Measured: Days 57, 85 and 169
Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA
Binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins as measured by ELISA was reported. LLOQ was 58 IU/mL.
Measured: Days 57, 85, 169
Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Measured: 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 20209 Mar 2022

First posted2 Sep 2020
Study start28 Aug 2020
Primary completion9 Mar 2022
Study completion9 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 635 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04535453
Sponsor's protocol ID: CR108854
Other IDs: VAC31518COV2001, 2020-002584-63
Status last verified: Jun 2023
First submitted: 27 Aug 2020
Last updated: 22 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Expanded access: Available

Publications

Cardenas V, Le Gars M, Truyers C, Ruiz-Guinazu J, Struyf F, Colfer A, Bonten M, Borobia A, Reisinger EC, Kamerling IMC, Douoguih M, Sadoff J. Safety and immunogenicity of Ad26.COV2.S in adults: A randomised, double-blind, placebo-controlled Phase 2a dose-finding study. Vaccine. 2024 Jun 11;42(16):3536-3546. doi: 10.1016/j.vaccine.2024.04.059. Epub 2024 May 4.
PubMed 38705804
Sadoff J, Le Gars M, Brandenburg B, Cardenas V, Shukarev G, Vaissiere N, Heerwegh D, Truyers C, de Groot AM, Jongeneelen M, Kaszas K, Tolboom J, Scheper G, Hendriks J, Ruiz-Guinazu J, Struyf F, Van Hoof J, Douoguih M, Schuitemaker H. Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials. Vaccine. 2022 Jul 30;40(32):4403-4411. doi: 10.1016/j.vaccine.2022.05.047. Epub 2022 Jun 3.
PubMed 35667914

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

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What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive
ClinicalTrials.gov ID: NCT04535453
Acronym / sponsor ID: CR108854
Conditions: Healthy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 635 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Study start: 28 Aug 2020 (actual)
Primary completion: 9 Mar 2022 (actual)
Study completion: 9 Mar 2022 (actual)
First posted: 2 Sep 2020 (actual)
Results: Posted 22 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

And the highlighted text in the ICF document are the guidance for country specific adaptation.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Groups 1-6	Experimental	Biological: Ad26.COV2.S, Other: PlaceboParticipants will receive a 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 57 at different dose levels (Groups 1-3), or a single-dose Ad26.COV2.S vaccination regimen at different dose levels (Groups 4-5), or placebo (Group 6). At unblinded phase, participants in Group 6 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Groups 1-5) or placebo (Group 6).
Groups 7-8	Experimental	Biological: Ad26.COV2.S, Other: PlaceboParticipants will receive 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 29 at fixed dose level (Groups 7) or placebo (Groups 8). At unblinded phase, participants in Group 8 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Group 7) or placebo (Group 8).
Groups 9-10	Experimental	Biological: Ad26.COV2.S, Other: PlaceboParticipants will receive 2-dose Ad26.COV2.S vaccination regimen at Days 1 and 85 at fixed dose level (Group 9) or placebo (Group 10). At unblinded phase, participants in Group 10 initially receiving placebo will be offered 2 doses of Ad26.COV2.S vaccine at a single dose level, at a 28-day interval. Participants will also receive a single antigen presentation injection with single dose level of Ad26.COV2.S at 4 months after second vaccination (Group 9) or placebo (Group 10).
Groups A-C	Experimental	Biological: Ad26.COV2.S, Other: PlaceboParticipants will receive a single dose Ad26.COV2.S vaccination regimen at Day 1 at fixed dose level (Groups A and B) or placebo (Group C). At approximately 6 months of study participation (unblinded phase), participants in Group C initially receiving placebo will receive Ad26.COV2.S vaccine at a single dose level, at a 56-day interval.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (12 listed)

For Adults
Participant must have a body mass index (BMI) less than (<) 30.0 kilogram per meter square (kg/m^2)
Participant is 18 to 55 years of age, inclusive, or 65 years of age or older on the day of signing the informed consent form (ICF).
Participant 18 to 55 years of age, inclusive: participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19), except for smoking and mild hypertension, which are allowed. Participant 65 years of age and older: In the investigator's clinical judgment, participant must be either in good or stable health. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19, except for smoking and mild hypertension, which are allowed. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participant will be included on the basis of physical examination, medical history, and vital signs
Participant will be included on the basis of physical examination, medical history, and vital signs

Key exclusion criteria (10 listed)

For Adults
Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius [C] (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
Participant received treatment with immunoglobulins in the 3 months or blood products in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ad26.COV2.SAlso: JNJ-78436735, Ad26COVS1All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.	Biological	Groups 1-6, Groups 7-8, Groups 9-10, Groups A-C
PlaceboAdult participants in Groups 4, 5, 6, 8, and 10, and adolescent participants in Group C will receive at least one injection of placebo.	Other	Groups 1-6, Groups 7-8, Groups 9-10, Groups A-C

Primary outcome

Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2
Time frame: 28 days after Vaccination 2 (Day 85)
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was less than or equal to the lower limit of quantification (<=LLOQ) and the post-baseline sample was greater than (>) LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (greater than or equal to [>=] 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were 50 percent (%) inhibitory concentration (IC50) of 58 and 12,800 international unit per milliliter (IU/mL) respectively.
Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2
Time frame: 28 days after Vaccination 2 (Day 85)
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2
Time frame: 28 days after Vaccination 2 (Day 85)
Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported.
Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2
Time frame: 28 days after Vaccination 2 (Day 85)
Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported.
Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers at 28 Days After Vaccination 1
Time frame: 28 days after Vaccination 1 (Day 29)
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1
Time frame: 28 days after Vaccination 1 (Day 29)
Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1
Time frame: 28 days after Vaccination 1 (Day 29)
Antibody GMTs as measured by VNA at 28 days after vaccination 1 were reported. LLOQ was 58 IU/mL.
Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1
Time frame: 28 days after Vaccination 1 (Day 29)
Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 1 were reported. The LLOQ was 50.3 IU/mL.
Adults of Groups 9 and 10: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 2
Time frame: 28 days after Vaccination 2 ( Day 113)
Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Adults of Groups 9 and 10: Percentage of Participant With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2
Time frame: 28 days after Vaccination 2 (Day 113)
Percentage of participant with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.
Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2
Time frame: 28 days after Vaccination 2 (Day 113)
Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported. The LLOQ was 58 IU/mL.
Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2
Time frame: 28 Days after Vaccination 2 (Day 113)
Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported. The LLOQ was 50.3 IU/mL.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1
Time frame: 7 days after Vaccination 1 (Day 8)
Number of participants with solicited local AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days after vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1
Time frame: 7 days after Vaccination 1 (Day 8)
Number of participants with solicited systemic AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2
Time frame: 7 days after Vaccination 2 (Day 64 for Groups 1-6; Day 92 for Groups 9 and 10)
Number of participants with solicited local AEs at 7 days after vaccination 2 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days post vaccination 2 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2
Time frame: 7 days after Vaccination 2 (Day 64 for Group 1-6; Day 92 for Group 9 and 10)
Number of participants with solicited systemic AEs at 7 days after vaccination 2 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 2 (Day of vaccination 2 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1
Time frame: 28 days after Vaccination 1 (Day 29)
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2
Time frame: 28 days After Vaccination 2 (Day 85 for Groups 1-6; Day 113 for Groups 9 and 10)
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 1.5 years
SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to 1.5 years
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Adolescents: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 1
Time frame: 7 Days After Vaccination 1 (Day 8)
Number of participants with solicited local AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days post vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Adolescents: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 1
Time frame: 7 Days After Vaccination 1 (Day 8)
Number of participants with solicited systemic AEs at 7 days after vaccination 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 1 (Day of vaccination1 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).
Adolescents: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1
Time frame: 28 Days After Vaccination 1 (Day 29)
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.
Adolescents: Number of Participants With SAEs (Inclusive Multisystem Inflammatory Syndrome in Children [MIS-C])
Time frame: Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)
SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
Adolescents: Number of Participants With AESIs
Time frame: Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.

22 secondary outcomes

Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation
Time frame: 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9)
Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation
Time frame: 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9)
Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation
Time frame: 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)
Adults of Group 7: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation
Time frame: Day 148
Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation
Time frame: 7 Days after Antigen Presentation (Day 176 for Groups 1-5; Day 204 for Group 9)
Adults of Group 7: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation
Time frame: Day 148
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation
Time frame: 7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation
Time frame: 7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation
Time frame: 28 Days After Antigen Presentation (Day 197 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 225 for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation
Time frame: After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10)
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation
Time frame: After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10)
Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA
Time frame: Days 197 and 393
Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA
Time frame: Days 225 and 421
Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins
Time frame: Days 197 and 393
Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins
Time frame: Days 225 and 421
Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29)
Time frame: 28 Days After Vaccination 1 (Day 29)
Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29)
Time frame: 28 Days After Vaccination 1 (Day 29)
Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1
Time frame: 28 days After Vaccination 1 (Day 29)
Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1
Time frame: 28 days After Vaccination 1 (Day 29)
Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA
Time frame: Days 57, 85 and 169
Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA
Time frame: Days 57, 85, 169
Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation
Time frame: 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)

Results and safety

Results posted to the registry on 22 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Ad26.COV2.S 510^10 vp, Ad26.COV2.S 510^10 vp, Ad26.COV2.S 1.25*10^10 vp	86	82
Group 2: Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 1.25*10^10 vp	81	73
Group 3: Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.25*10^10 vp	75	70
Group 4: Ad26.COV2.S 110^11 vp, Placebo, Ad26.COV2.S 1.2510^10 vp	74	70
Group 5: Ad26.COV2.S 510^10 vp, Placebo, Ad26.COV2.S 1.2510^10 vp	81	75
Group 6: Placebo, Placebo, Placebo	26	24
Group 7: Ad26.COV2.S 510^10 vp, Ad26.COV2.S 510^10 vp, Ad26.COV2.S 1.25*10^10 vp	56	54
Group 8: Placebo, Placebo, Placebo	27	25
Group 9: Ad26.COV2.S 510^10 vp, Ad26.COV2.S 510^10 vp, Ad26.COV2.S 1.25*10^10 vp	53	50
Group 10: Placebo, Placebo, Placebo	25	23
Group A and B Combined: Ad26.COV2.S 2.5*10^10	30	30
Group C: Placebo	3	2

Primary outcome: Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2

Time frame: 28 days after Vaccination 2 (Day 85). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1: Ad26.COV2.S 510^10 vp, Ad26.COV2.S 510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 31	Group 2: Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 36	Group 3: Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 36
Value	96.8 (83.3)	100.0 (90.3)	88.9 (73.9)

Population analysed: Per protocol immunogenicity (PPI) set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (positive PCR test or N-serology) after screening were excluded from analysis. N(Overall number of participants analyzed) signifies participants evaluated for this outcome measure(OM).

Primary outcome: Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2

Time frame: 28 days after Vaccination 2 (Day 85). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1: Ad26.COV2.S 510^10 vp, Ad26.COV2.S 510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 68	Group 2: Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 67	Group 3: Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 60
Value	100.0 (94.7)	100.0 (94.6)	96.7 (88.5)

Population analysed: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Primary outcome: Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2

Time frame: 28 days after Vaccination 2 (Day 85). Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Group 1: Ad26.COV2.S 510^10 vp, Ad26.COV2.S 510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 32	Group 2: Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 36	Group 3: Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 37
Value	455 (321)	490 (376)	364 (239)

Primary outcome: Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2

Time frame: 28 days after Vaccination 2 (Day 85). Geometric mean (95% Confidence Interval). Unit: ELISA unit per milliliter (EU/mL)

Measure	Group 1: Ad26.COV2.S 510^10 vp, Ad26.COV2.S 510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 71	Group 2: Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 68	Group 3: Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.25*10^10 vp n = 60
Value	1742 (1400)	1563 (1273)	1130 (802)

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1.5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Ad26.COV2.S 510^10 vp, Ad26.COV2.S 510^10 vp, Ad26.COV2.S 1.25*10^10 vp	7 of 141 (5%)	35 of 141 (24.8%)	0 of 141
Group 2: Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 2.510^10 vp, Ad26.COV2.S 1.25*10^10 vp	1 of 81 (1.2%)	24 of 81 (29.6%)	1 of 81
Group 3: Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.2510^10 vp, Ad26.COV2.S 1.25*10^10 vp	1 of 75 (1.3%)	20 of 75 (26.7%)	0 of 75
Group 4: Ad26.COV2.S 110^11 vp, Placebo, Ad26.COV2.S 1.2510^10 vp	1 of 74 (1.4%)	20 of 74 (27%)	0 of 74
Group 5: Ad26.COV2.S 510^10 vp, Placebo, Ad26.COV2.S 1.2510^10 vp	2 of 81 (2.5%)	33 of 81 (40.7%)	0 of 81
Group 6: Placebo, Placebo, Placebo	0 of 52 (0%)	11 of 52 (21.2%)	0 of 52
Group 7: Ad26.COV2.S 510^10 vp, Ad26.COV2.S 510^10 vp, Ad26.COV2.S 1.25*10^10 vp	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Group 8: Placebo, Placebo, Placebo	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Group 9: Ad26.COV2.S 510^10 vp, Ad26.COV2.S 510^10 vp, Ad26.COV2.S 1.25*10^10 vp	1 of 53 (1.9%)	16 of 53 (30.2%)	0 of 53
Group 10: Placebo, Placebo, Placebo	0 of 25 (0%)	9 of 25 (36%)	0 of 25
Group A and B Combined: Ad26.COV2.S 2.5*10^10	0 of 30 (0%)	11 of 30 (36.7%)	0 of 30
Group C: Placebo	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38705804Cardenas V, Le Gars M, Truyers C, Ruiz-Guinazu J, Struyf F, Colfer A, Bonten M, Borobia A, Reisinger EC, Kamerling IMC, Douoguih M, Sadoff J. Safety and immunogenicity of Ad26.COV2.S in adults: A randomised, double-blind, placebo-controlled Phase 2a dose-finding study. Vaccine. 2024 Jun 11;42(16):3536-3546. doi: 10.1016/j.vaccine.2024.04.059. Epub 2024 May 4.
Derived from this study: PubMed 35667914Sadoff J, Le Gars M, Brandenburg B, Cardenas V, Shukarev G, Vaissiere N, Heerwegh D, Truyers C, de Groot AM, Jongeneelen M, Kaszas K, Tolboom J, Scheper G, Hendriks J, Ruiz-Guinazu J, Struyf F, Van Hoof J, Douoguih M, Schuitemaker H. Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials. Vaccine. 2022 Jul 30;40(32):4403-4411. doi: 10.1016/j.vaccine.2022.05.047. Epub 2022 Jun 3.
Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Vaccines & Prevention B.V. Clinical Trial study director

Janssen Vaccines & Prevention B.V.

13 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ad26.COV2.S in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United Kingdom, Germany, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2 (time frame: 28 days after Vaccination 2 (Day 85)). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04535453, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.