COVID-19 PreventionPhase 3NCT04908722
A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults
A Phase 3 study testing Ad26.COV2.S in people with COVID-19 Prevention, run by Janssen Vaccines & Prevention B.V. at 43 sites in 5 countries.
Trial summary
The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Prevention
- What is being tested?
- Ad26.COV2.S
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,609 participants
- Where
- 43 sitesin 5 countries
- Study dates
- 18 Jun 2021to 10 Jul 2023
- Phase
- Phase 3
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
- Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. 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 Coronavirus disease 2019 (COVID-19), except for smoking, which is 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
- All female 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
- 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
Who cannot join
- 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 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 or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccinations; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations
- 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 immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine 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
- Participant previously received a coronavirus vaccine
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
United States18 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009
Ventavia Research Group, LLC
Keller, Texas, 76248
Clinical Research Center of Nevada
Las Vegas, Nevada, 89106
Baptist Health Center For Clinical Research
Little Rock, Arkansas, 72205
Ark Clinical Research
Long Beach, California, 90815
Medpharmics, LLC
Metairie, Louisiana, 70006
Floridian Research Institute
Miami, Florida, 33179
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Research Your Health
Plano, Texas, 75093
Wake Research Associates
Raleigh, North Carolina, 27612
Paradigm Clinical Research Centers, Inc.
Redding, California, 96001
Clinical Research Partners, LLC
Richmond, Virginia, 23226
Rochester Clinical Research, Inc
Rochester, New York, 14609
Wr McCr Llc
San Diego, California, 92120
Ark Clinical Research
Tustin, California, 92780
Trial Management Associates, LLC
Wilmington, North Carolina, 28403
Tekton Research Inc.
Yukon, Oklahoma, 73099
Brazil11 sites
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, 30130-100
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221
CECOR Centro OncolOgico de Roraima
Boa Vista, 69304-415
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas, 13060-904
Núcleo de Medicina Tropical - Universidade Federal do Ceará
Ceará, 60430-160
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciúma, 88811-508
Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
Natal, 59025-050
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, 14048-900
Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
Rio de Janeiro, 26030-380
CPQuali Pesquisa Clinica LTDA ME
São Paulo, 01228-000
Centro de Referencia E Treinamento Dst/Aids
São Paulo, 04121-000
South Africa6 sites
Synexus Helderberg Clinical Research Centre
Cape Town, 7130
Ndlovu Elandsdoorn Site
Dennilton, 0485
Stanza Clinical Research Centre : Mamelodi
Mamelodi East, 122
PHOENIX PHARMA (Pty) Ltd
Port Elizabeth, 6001
Gct Sunnyside
Pretoria, 0002
Setshaba Research Centre
Soshanguve, 152
Germany5 sites
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10787
Clinical Research HamburggmbH
Hamburg, 22143
Klinische Forschung Hannover-Mitte GmbH
Hanover, 30159
Synexus Clinical Research GmbH
Leipzig, 04103
Universitaetsmedizin Rostock
Rostock, 18057
Poland3 sites
Gdanskie Centrum Zdrowia
Gdansk, 80-542
Centrum Medyczne Medyk
Rzeszów, 35-055
Centrum Medyczne Pratia Poznan
Skorzewo, 60 185
About this study
Official title: A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedule in Healthy Adults
The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S.
- Conditions
- COVID-19 Prevention
- Being tested
- Ad26.COV2.S
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, VAC31518
Participants will receive intramuscular (IM) injections of Ad26.COV2.S.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Ad26.COV2.S Dose Level 1 | Experimental | Participants in the main study and sub study will receive intramuscular (IM) injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 1 on Days 1 and 57. Receives: Biological: Ad26.COV2.S |
| Group 2: Ad26.COV2.S Dose Level 2 | Experimental | Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 2 on Days 1 and 57 in the main study. Receives: Biological: Ad26.COV2.S |
| Group 3: Ad26.COV2.S Dose Level 3 | Experimental | Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 3 on Days 1 and 57. Receives: Biological: Ad26.COV2.S |
| Group 4: Ad26.COV2.S Dose Level 4 | Experimental | Participants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 4 on Days 1 and 57 in the main study. Receives: Biological: Ad26.COV2.S |
| Group 5: Ad26.COV2.S Dose Level 5 | Experimental | Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 5 on Days 1 and 57. Receives: Biological: Ad26.COV2.S |
| Group 6: Ad26.COV2.S Dose Level 6 | Experimental | Participants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 6 on Days 1 and 57. Receives: Biological: Ad26.COV2.S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: 28 days after first vaccination (at Day 29)
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: 14 days after second vaccination (at Day 71)
Secondary outcomes (9)
Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
Percentage of participants with serological response to vaccination to SARS-COV-2 S protein as measured by ELISA were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) the baseline (pre-dose 1) sample value was less than or equal to (<=) lower limit of quantification (LLOQ) and the post-baseline sample was greater than (>) LLOQ; (2) the baseline sample (pre-dose 1) value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>=4-fold) increase from the baseline sample value. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: Day 29, Day 57, Day 71, Week 32, and Week 60
Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
Geometric mean concentration of SARS-CoV-2 S protein binding antibody measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: Day 29, Day 57, Day 71, Week 32, and Week 60
Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination
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 participant in their e-diary for 7 days after each vaccination. Solicited local AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination
An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) were noted in the subject diary after 7 days of each vaccination. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
Unsolicited AEs were all AEs for which the subject was not specifically questioned in the subject diary. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: 28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85])
Number of Participants With Serious Adverse Events (SAEs)
SAE was any untoward medical occurrence that at any dose may results 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. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
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 were considered to be an AESI. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Number of Participants With AEs Leading to Study Discontinuation
Number of participants with AEs leading to study discontinuation were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: Up to 60 weeks
Number of Participants With Medically-Attended Adverse Events (MAAEs)
MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Measured: 6 months after second vaccination (up to 32 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start18 Jun 2021
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
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.
- Other trials for COVID-19 PreventionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908722
- Sponsor's protocol ID
- CR108960
- Other IDs
- 2020-005801-14, VAC31518COV3003
- Status last verified
- Jan 2025
- First submitted
- 27 May 2021
- Last updated
- 4 Feb 2025
- 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedule in Healthy Adults
- ClinicalTrials.gov ID
- NCT04908722
- Acronym / sponsor ID
- CR108960
- Conditions
- COVID-19 Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,609 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 23 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: Ad26.COV2.S Dose Level 1 | Experimental | Biological: Ad26.COV2.SParticipants in the main study and sub study will receive intramuscular (IM) injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 1 on Days 1 and 57. |
| Group 2: Ad26.COV2.S Dose Level 2 | Experimental | Biological: Ad26.COV2.SParticipants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 2 on Days 1 and 57 in the main study. |
| Group 3: Ad26.COV2.S Dose Level 3 | Experimental | Biological: Ad26.COV2.SParticipants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 3 on Days 1 and 57. |
| Group 4: Ad26.COV2.S Dose Level 4 | Experimental | Biological: Ad26.COV2.SParticipants will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 4 on Days 1 and 57 in the main study. |
| Group 5: Ad26.COV2.S Dose Level 5 | Experimental | Biological: Ad26.COV2.SParticipants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 5 on Days 1 and 57. |
| Group 6: Ad26.COV2.S Dose Level 6 | Experimental | Biological: Ad26.COV2.SParticipants in the main study and sub study will receive IM injections of Ad26.COV2.S as a 2-dose vaccination regimen at dose level 6 on Days 1 and 57. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
- Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. 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 Coronavirus disease 2019 (COVID-19), except for smoking, which is 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
- All female 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
- 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
Key exclusion criteria (5 listed)
- 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 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 or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccinations; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations
- 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 immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine 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
- Participant previously received a coronavirus vaccine
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, Ad26COVS1, VAC31518Participants will receive intramuscular (IM) injections of Ad26.COV2.S. | Biological | Group 1: Ad26.COV2.S Dose Level 1, Group 2: Ad26.COV2.S Dose Level 2, Group 3: Ad26.COV2.S Dose Level 3, Group 4: Ad26.COV2.S Dose Level 4, Group 5: Ad26.COV2.S Dose Level 5, Group 6: Ad26.COV2.S Dose Level 6 |
Primary outcome
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination
Time frame: 28 days after first vaccination (at Day 29)
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination
Time frame: 14 days after second vaccination (at Day 71)
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
9 secondary outcomes
Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
Time frame: Day 29, Day 57, Day 71, Week 32, and Week 60
Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
Time frame: Day 29, Day 57, Day 71, Week 32, and Week 60
Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination
Time frame: 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination
Time frame: 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
Time frame: 28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85])
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Number of Participants With AEs Leading to Study Discontinuation
Time frame: Up to 60 weeks
Number of Participants With Medically-Attended Adverse Events (MAAEs)
Time frame: 6 months after second vaccination (up to 32 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ad26.COV2.S in people with COVID-19 Prevention, run by Janssen Vaccines & Prevention B.V. at 43 sites in 5 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 5 inclusion and 5 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Brazil, South Africa, Germany, Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 May 2024). 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?
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination (time frame: 28 days after first vaccination (at Day 29)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025.