Coronavirus DiseasePhase 2AmplifyNCT04999111

A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2

A Phase 2 study testing Ad26.COV2.S in people with Coronavirus Disease, run by Janssen Vaccines & Prevention B.V. at 21 sites in United States.

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 18 years and olderHealthy volunteers can take part
Conditions the study is for: Coronavirus Disease
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: 1,541 participants
Where: 21 sitesUnited States
Study dates: 6 Aug 2021to 22 Nov 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Cohort 1: Participant received Ad26.COV2.S in VAC31518COV3001. The interval between the Ad26.COV2.S primary vaccination should preferably be greater than or equal to (>=) 6 months prior to study vaccination on VAC31518COV2008, however a window of maximum -20 days is allowed; Cohort 2: Participant completed primary vaccination with a 2-dose regimen of BNT162b2 vaccine. The last dose of BTN162b2 should preferably be >=6 months prior to study vaccination on COV2008, however a window of a maximum of -20 days is allowed
Participant must provide consent 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 agrees to not donate bone marrow, blood, and blood products from the study vaccine administration until 3 months after receiving the study vaccine
Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Participant must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the Coronavirus disease (COVID-19) signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the eCOA questionnaires

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 >= 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned study vaccination; randomization at a later date is permitted at the discretion of the investigator. Please notify the sponsor (or medical monitor) of this decision
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 (Ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study
Participant has a known history of confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection
Participant has a history of heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia
Participant has a history of acute polyneuropathy (example. Guillain-Barre syndrome)
History of capillary leak syndrome

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
Massachusetts General Hospital
Boston, Massachusetts, 02114
Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009
Research Centers of America, LLC
Hollywood, Florida, 33024
Crofoot Research Center
Houston, Texas, 77098
Johnson County Clin-Trials
Lenexa, Kansas, 66219
University of Kentucky
Lexington, Kentucky, 40536
Ark Clinical Research
Long Beach, California, 90815
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
Accellacare US Inc
Mt. Pleasant, South Carolina, 29464
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Velocity Clinical Research
North Hollywood, California, 91606
Synexus Clinical Research US Inc
Orlando, Florida, 32806
Optimal Research
Peoria, Illinois, 61614
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020
Rochester Clinical Research, Inc
Rochester, New York, 14609
Synexus Clinical Research US Inc
The Villages, Florida, 32162
Synexus Clinical Research US Inc
Tucson, Arizona, 85741
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Phase 2 Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Ad26.COV2.S Administered as Booster Vaccination in Adults 18 Years of Age and Older Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2

The purposes of this study are to demonstrate the non-inferiority (NI) of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels, administered greater than or equal to (>=) 6 months after single-dose primary vaccination with Ad26.COV2.S, compared to the neutralizing antibody response to the original strain induced by single-dose primary vaccination with Ad26.COV2.S; To demonstrate the NI of the neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5*10^10 virus particle (vp) dose level, administered >= 6 months after single-dose primary vaccination with Ad26.COV2.S (5*10^10 vp dose level), compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by single-dose primary vaccination with Ad26.COV2.S at the 5*10^10 vp dose level, if feasible; To demonstrate the NI of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels administered >=6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the original strain induced by 2-dose primary vaccination with Pfizer BNT162b2; To demonstrate the NI of neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5*10^10 vp dose level, administered >= 6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by 2-dose primary vaccination with Pfizer BNT162b2, if feasible.

Conditions: Coronavirus Disease
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, VAC31518
Participants will receive IM injection of Ad26.COV2.S.

Study groups in NCT04999111
Study group	Role	What they receive
Cohort 1: Group 1: Ad26.COV2.S (Dose Level 1)	Experimental	Participants who have previously received primary vaccination with Ad26.COV2.S will receive single intramuscular (IM) injection of Ad26.COV2.S booster vaccination at dose level 1 on Day 1. Receives: Biological: Ad26.COV2.S
Cohort 1: Group 2: Ad26.COV2.S (Dose Level 2)	Experimental	Participants who have previously received primary vaccination with Ad26.COV2.S will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 2 on Day 1. Receives: Biological: Ad26.COV2.S
Cohort 1: Group 3: Ad26.COV2.S (Dose Level 3)	Experimental	Participants who have previously received primary vaccination with Ad26.COV2.S will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 3 on Day 1. Receives: Biological: Ad26.COV2.S
Cohort 2: Group 4: Ad26.COV2.S (Dose Level 1)	Experimental	Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 1 on Day 1. Receives: Biological: Ad26.COV2.S
Cohort 2: Group 5: Ad26.COV2.S (Dose Level 2)	Experimental	Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 2 on Day 1. Receives: Biological: Ad26.COV2.S
Cohort 2: Group 6: Ad26.COV2.S (Dose Level 3)	Experimental	Participants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 3 on Day 1. Receives: Biological: Ad26.COV2.S

What is being measured

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

Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 original strain (Wuhan, 2019, whole genome sequence) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S was reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer less than (<) lower limit of quantification (LLOQ) and post-booster titer greater than or equal to (>=) 4*LLOQ or (2) Pre-booster titer greater than (>) LLOQ and post-booster titer >=4*pre-booster titer value.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15)
Cohort 1: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. GMT against original strain was assessed by virus neutralization assay (VNA).
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15)
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 original strain 28 days after primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value.
Measured: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
Cohort 1: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 28 days after primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. GMT against original strain was assessed by VNA.
Measured: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
Cohort 1: Percentage of Participants With Serological Response Against the Delta Variant 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against leading variant of high consequence or concern (delta variant) 14 days after Ad26.COV2.S booster vaccination (5*10^10 vp Dose Level) after completing primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer <LLOQ and post-booster titer >=4*LLOQ or (2) Pre-booster titer >LLOQ and post-booster titer >=4*pre-booster titer value. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
GMTs of neutralizing antibodies against leading variant of high consequence or concern (delta variant) 14 days After Ad26.COV2.S booster vaccination (5*10^10 vp dose level) after completing primary vaccination with Ad26.COV2.S were reported. GMT against Delta Variant was assessed by VNA. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (delta variant) 28 days after primary vaccination with Ad26.COV2.S (5*10^10 vp dose level) were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants.
Measured: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S (5*10^10 vp Dose Level)
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (delta variant) 28 days after primary vaccination with Ad26.COV2.S (5*10^10 vp dose level) were reported. GMT against Delta variant was assessed by VNA. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants. Lower limit of Quantification (LLOQ) was 65.
Measured: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2
Percentage of participants with serological response against SARS-CoV-2 original strain, 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against original strain was assessed by VNA.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
Percentage of participants with serological response against SARS-CoV-2 original strain 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were planned to be reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-dose 1 titer <LLOQ, then post-vaccination titer >=4*LLOQ. (2) If pre-dose 1 titer >LLOQ, then post-vaccination titer >=4*pre-dose 1 value (titer).
Measured: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against original strain was assessed by VNA.
Measured: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Delta Variant 14 Days After Booster Vaccination (5*10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (Delta) 14 days after booster vaccination (5*10^10 vp dose level) after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions was satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer). As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 2: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Booster Vaccination (5*10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2
Antibody GMTs of neutralizing antibodies against the SARS-CoV-2 leading variant of high consequence or concern (Delta variant) 14 days after booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against delta variant was assessed by VNA. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 2: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: Percentage of Participants With Seropositive Response to Vaccination Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing Primary Vaccination With 2-dose BNT162b2 (Pfizer BNT162b2 External Samples)
Percentage of participants with seropositive response to vaccination against the SARS-CoV-2 leading variant of high consequence or concern (Delta) 2 weeks to 2 months after completing primary vaccination with 2-dose BNT162b2 were planned to be reported. A participant was considered a responder if one or both of the following conditions was satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ. or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value.
Measured: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
Antibody GMTs of neutralizing antibodies against the SARS-CoV-2 leading variant of high consequence or concern (Delta variant) 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against delta variant was assessed by VNA.
Measured: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)

Secondary outcomes (26)

Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) After Ad26.COV2.S Booster Vaccination
Participants who received the booster dose were asked to note the occurrence of injection site pain, erythema, and swelling at the study vaccine injection site in e-Diary daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).
Measured: Up to 7 days after booster vaccination (Up to Day 8)
Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs After Ad26.COV2.S Booster Vaccination
Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.
Measured: Up to 7 days after booster vaccination (Up to Day 8)
Cohorts 1 and 2: Number of Participants With Unsolicited AEs After Ad26.COV2.S Booster Vaccination
Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Measured: Up to 28 days after booster vaccination (Up to Day 29)
Cohorts 1 and 2: Number of Participants With Serious Adverse Events (SAEs) After Ad26.COV2.S Booster Vaccination
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: From booster vaccination (Day 1) until 1 year post booster vaccination
Cohorts 1 and 2: Number of Participants With Adverse Events of Special Interest (AESIs) After Ad26.COV2.S Booster Vaccination
Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals.
Measured: From booster vaccination (Day 1) until 1 year post booster vaccination
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 14 Days After Ad26.COV2.S Booster Vaccination
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination were reported. GMT against original strain was assessed by VNA.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination were reported.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Measured: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported.
Measured: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination were reported. GMT was assessed by VNA.
Measured: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination were reported.
Measured: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 1: Percentage of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Enzyme-linked Immunosorbent Assay (ELISA)
Percentage of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV-2 Proteins by ELISA were planned to be reported.
Measured: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 1: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Meso Scale Discovery (MSD)
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV-2 Proteins by MSD were planned to be reported.
Measured: From booster vaccination (Day 1) until 1 year from booster vaccination
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Percentage of participants with serological response to vaccination against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions was satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Percentage of participants with serological response to vaccination against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 was reported.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Antibody GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Antibody GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Measured: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Percentage of participants with serological response to vaccination against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (Beta variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions was satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Measured: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Percentage of participants with serological response to vaccination against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b were reported.
Measured: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 2: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Measured: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 2: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Measured: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 2: Percentage of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by ELISA
Percentage of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV- 2 proteins by ELISA were planned to be reported.
Measured: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 2: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by MSD
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV- 2 proteins by MSD were planned to be reported.
Measured: From booster vaccination (Day 1) until 1 year from booster vaccination
Cohorts 1 and 2: Number of Participants With Antibodies Binding to the SARS-CoV-2 Nucleocapsid (N) Protein at Day 1 as Assessed by N-Serology
Number of participants with antibodies binding to the SARS-CoV-2 nucleocapsid (N) protein at Day 1 as assessed by N-serology were planned to be reported.
Measured: Day 1

Timeline

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

6 Aug 202122 Nov 2022

First posted10 Aug 2021
Study start6 Aug 2021
Primary completion27 Oct 2021
Study completion22 Nov 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 Coronavirus DiseaseStudies 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: 1,541 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04999111
Sponsor's protocol ID: CR109060
Other IDs: VAC31518COV2008
Acronym: Amplify
Status last verified: Jan 2025
First submitted: 3 Aug 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

Publications

Roels S, Bruckner M, Sadoff J, Cardenas V, Tang C, Hagedoorn S, Heerwegh D, Stieh DJ, Le Gars M. Pre- and post-Ad26.COV2.S booster dose antibody levels predict COVID-19 disease risk. Vaccine. 2024 Sep 17;42(22):126159. doi: 10.1016/j.vaccine.2024.126159. Epub 2024 Aug 8.
PubMed 39121698
Le Gars M, Sadoff J, Cardenas V, Heerwegh D, Tesfaye F, Roey GV, Spicer C, Matias SS, Crayne O, Kamphuis T, Struyf F, Schuitemaker H, Douoguih M. Safety, reactogenicity, and immunogenicity of Ad26.COV2.S as homologous or heterologous COVID-19 booster vaccination: Results of a randomized, double-blind, phase 2 trial. Vaccine. 2024 Jul 25;42(19):3938-3952. doi: 10.1016/j.vaccine.2024.03.079. Epub 2024 Jun 25.
PubMed 38918103

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

Questions to ask the study team

What is the study trying to find out?
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Could I receive a placebo instead of the treatment?
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All Coronavirus Disease trials

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 2 Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Ad26.COV2.S Administered as Booster Vaccination in Adults 18 Years of Age and Older Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
ClinicalTrials.gov ID: NCT04999111
Acronym / sponsor ID: Amplify / CR109060
Conditions: Coronavirus Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,541 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Study start: 6 Aug 2021 (actual)
Primary completion: 27 Oct 2021 (actual)
Study completion: 22 Nov 2022 (actual)
First posted: 10 Aug 2021 (actual)
Results: Posted 5 Jan 2023

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Cohort 1: Group 1: Ad26.COV2.S (Dose Level 1)	Experimental	Biological: Ad26.COV2.SParticipants who have previously received primary vaccination with Ad26.COV2.S will receive single intramuscular (IM) injection of Ad26.COV2.S booster vaccination at dose level 1 on Day 1.
Cohort 1: Group 2: Ad26.COV2.S (Dose Level 2)	Experimental	Biological: Ad26.COV2.SParticipants who have previously received primary vaccination with Ad26.COV2.S will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 2 on Day 1.
Cohort 1: Group 3: Ad26.COV2.S (Dose Level 3)	Experimental	Biological: Ad26.COV2.SParticipants who have previously received primary vaccination with Ad26.COV2.S will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 3 on Day 1.
Cohort 2: Group 4: Ad26.COV2.S (Dose Level 1)	Experimental	Biological: Ad26.COV2.SParticipants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 1 on Day 1.
Cohort 2: Group 5: Ad26.COV2.S (Dose Level 2)	Experimental	Biological: Ad26.COV2.SParticipants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 2 on Day 1.
Cohort 2: Group 6: Ad26.COV2.S (Dose Level 3)	Experimental	Biological: Ad26.COV2.SParticipants who have previously received primary vaccination with BNT162b2 will receive single IM injection of Ad26.COV2.S booster vaccination at dose level 3 on Day 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Cohort 1: Participant received Ad26.COV2.S in VAC31518COV3001. The interval between the Ad26.COV2.S primary vaccination should preferably be greater than or equal to (>=) 6 months prior to study vaccination on VAC31518COV2008, however a window of maximum -20 days is allowed; Cohort 2: Participant completed primary vaccination with a 2-dose regimen of BNT162b2 vaccine. The last dose of BTN162b2 should preferably be >=6 months prior to study vaccination on COV2008, however a window of a maximum of -20 days is allowed
Participant must provide consent 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 agrees to not donate bone marrow, blood, and blood products from the study vaccine administration until 3 months after receiving the study vaccine
Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Participant must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the Coronavirus disease (COVID-19) signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the eCOA questionnaires

Key exclusion criteria (7 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 >= 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned study vaccination; randomization at a later date is permitted at the discretion of the investigator. Please notify the sponsor (or medical monitor) of this decision
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 (Ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study
Participant has a known history of confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection
Participant has a history of heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia

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, VAC31518Participants will receive IM injection of Ad26.COV2.S.	Biological	Cohort 1: Group 1: Ad26.COV2.S (Dose Level 1), Cohort 1: Group 2: Ad26.COV2.S (Dose Level 2), Cohort 1: Group 3: Ad26.COV2.S (Dose Level 3), Cohort 2: Group 4: Ad26.COV2.S (Dose Level 1), Cohort 2: Group 5: Ad26.COV2.S (Dose Level 2), Cohort 2: Group 6: Ad26.COV2.S (Dose Level 3)

Primary outcome

Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15)
Percentage of participants with serological response against SARS-CoV-2 original strain (Wuhan, 2019, whole genome sequence) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S was reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer less than (<) lower limit of quantification (LLOQ) and post-booster titer greater than or equal to (>=) 4*LLOQ or (2) Pre-booster titer greater than (>) LLOQ and post-booster titer >=4*pre-booster titer value.
Cohort 1: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15)
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. GMT against original strain was assessed by virus neutralization assay (VNA).
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
Time frame: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
Percentage of participants with serological response against SARS-CoV-2 original strain 28 days after primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value.
Cohort 1: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
Time frame: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 28 days after primary vaccination with Ad26.COV2.S (5×10^10 vp dose level) were reported. GMT against original strain was assessed by VNA.
Cohort 1: Percentage of Participants With Serological Response Against the Delta Variant 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Percentage of participants with serological response against leading variant of high consequence or concern (delta variant) 14 days after Ad26.COV2.S booster vaccination (5*10^10 vp Dose Level) after completing primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer <LLOQ and post-booster titer >=4*LLOQ or (2) Pre-booster titer >LLOQ and post-booster titer >=4*pre-booster titer value. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants.
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
GMTs of neutralizing antibodies against leading variant of high consequence or concern (delta variant) 14 days After Ad26.COV2.S booster vaccination (5*10^10 vp dose level) after completing primary vaccination with Ad26.COV2.S were reported. GMT against Delta Variant was assessed by VNA. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants.
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S
Time frame: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (delta variant) 28 days after primary vaccination with Ad26.COV2.S (5*10^10 vp dose level) were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants.
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S (5*10^10 vp Dose Level)
Time frame: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (delta variant) 28 days after primary vaccination with Ad26.COV2.S (5*10^10 vp dose level) were reported. GMT against Delta variant was assessed by VNA. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants. Lower limit of Quantification (LLOQ) was 65.
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Percentage of participants with serological response against SARS-CoV-2 original strain, 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer).
Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against original strain was assessed by VNA.
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
Time frame: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
Percentage of participants with serological response against SARS-CoV-2 original strain 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were planned to be reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-dose 1 titer <LLOQ, then post-vaccination titer >=4*LLOQ. (2) If pre-dose 1 titer >LLOQ, then post-vaccination titer >=4*pre-dose 1 value (titer).
Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
Time frame: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against original strain was assessed by VNA.
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Delta Variant 14 Days After Booster Vaccination (5*10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (Delta) 14 days after booster vaccination (5*10^10 vp dose level) after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions was satisfied: (1) If pre-booster 1 titer <LLOQ, then post-booster titer >=4*LLOQ or (2) If pre-booster 1 titer >LLOQ, then post-booster titer >=4*pre-booster value (titer). As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 2: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants.
Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Booster Vaccination (5*10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Antibody GMTs of neutralizing antibodies against the SARS-CoV-2 leading variant of high consequence or concern (Delta variant) 14 days after booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against delta variant was assessed by VNA. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 2: Ad26.COV2.S 2.5*10^10 vp and 1*10^10 vp participants.
Cohort 2: Percentage of Participants With Seropositive Response to Vaccination Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing Primary Vaccination With 2-dose BNT162b2 (Pfizer BNT162b2 External Samples)
Time frame: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
Percentage of participants with seropositive response to vaccination against the SARS-CoV-2 leading variant of high consequence or concern (Delta) 2 weeks to 2 months after completing primary vaccination with 2-dose BNT162b2 were planned to be reported. A participant was considered a responder if one or both of the following conditions was satisfied: (1) Pre-dose titer <LLOQ and post-vaccination titer >=4*LLOQ. or (2) Pre-dose titer >LLOQ and post-vaccination titer >=4*pre-dose 1 titer value.
Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
Time frame: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)
Antibody GMTs of neutralizing antibodies against the SARS-CoV-2 leading variant of high consequence or concern (Delta variant) 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against delta variant was assessed by VNA.

26 secondary outcomes

Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) After Ad26.COV2.S Booster Vaccination
Time frame: Up to 7 days after booster vaccination (Up to Day 8)
Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs After Ad26.COV2.S Booster Vaccination
Time frame: Up to 7 days after booster vaccination (Up to Day 8)
Cohorts 1 and 2: Number of Participants With Unsolicited AEs After Ad26.COV2.S Booster Vaccination
Time frame: Up to 28 days after booster vaccination (Up to Day 29)
Cohorts 1 and 2: Number of Participants With Serious Adverse Events (SAEs) After Ad26.COV2.S Booster Vaccination
Time frame: From booster vaccination (Day 1) until 1 year post booster vaccination
Cohorts 1 and 2: Number of Participants With Adverse Events of Special Interest (AESIs) After Ad26.COV2.S Booster Vaccination
Time frame: From booster vaccination (Day 1) until 1 year post booster vaccination
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 14 Days After Ad26.COV2.S Booster Vaccination
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Time frame: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Time frame: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination
Time frame: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination
Time frame: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 1: Percentage of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 1: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Meso Scale Discovery (MSD)
Time frame: From booster vaccination (Day 1) until 1 year from booster vaccination
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Time frame: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Time frame: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 2: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Time frame: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 2: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Time frame: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 2: Percentage of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by ELISA
Time frame: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)
Cohort 2: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by MSD
Time frame: From booster vaccination (Day 1) until 1 year from booster vaccination
Cohorts 1 and 2: Number of Participants With Antibodies Binding to the SARS-CoV-2 Nucleocapsid (N) Protein at Day 1 as Assessed by N-Serology
Time frame: Day 1

Results and safety

Results posted to the registry on 5 Jan 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
Cohort 1: Ad26.COV2.S (5*10^10 vp)	331	277
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)	328	271
Cohort 1: Ad26.COV2.S (1*10^10 vp)	116	96
Cohort 2: Ad26.COV2.S (5*10^10 vp)	329	260
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)	331	251
Cohort 2: Ad26.COV2.S (1*10^10 vp)	106	84

Primary outcome: Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S

Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Cohort 1: Ad26.COV2.S (5*10^10 vp) n = 298	Cohort 1: Ad26.COV2.S (2.5*10^10 vp) n = 297	Cohort 1: Ad26.COV2.S (1*10^10 vp) n = 93
Value	63.4 (57.7 to 68.9)	57.9 (52.1 to 63.6)	64.5 (53.9 to 74.2)

Population analysed: Non-inferiority (NI) analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

Primary outcome: Cohort 1: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S

Time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15). Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Cohort 1: Ad26.COV2.S (5*10^10 vp) n = 298	Cohort 1: Ad26.COV2.S (2.5*10^10 vp) n = 297	Cohort 1: Ad26.COV2.S (1*10^10 vp) n = 93
Value	1130 (989 to 1291)	915 (792 to 1058)	734 (564 to 954)

Population analysed: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (overall number of participants analyzed) signifies participants evaluable for this outcome measure.

Primary outcome: Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S

Time frame: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Cohort 1: Ad26.COV2.S (5*10^10 vp) n = 312	Cohort 1: Ad26.COV2.S (2.5*10^10 vp) n = 315	Cohort 1: Ad26.COV2.S (1*10^10 vp) n = 111
Value	15.4 (11.6 to 19.9)	16.8 (12.9 to 21.4)	11.7 (6.4 to 19.2)

Population analysed: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

Primary outcome: Cohort 1: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S

Time frame: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001). Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Cohort 1: Ad26.COV2.S (5*10^10 vp) n = 312	Cohort 1: Ad26.COV2.S (2.5*10^10 vp) n = 315	Cohort 1: Ad26.COV2.S (1*10^10 vp) n = 112
Value	98 (85 to 113)	100 (87 to 115)	76 (NA to 92)

Population analysed: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

26 secondary outcomes are reported in the full results.

Adverse events

Time frame: From booster vaccination (Day 1) until 1 year post booster vaccination. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Ad26.COV2.S (5*10^10 vp)	11 of 330 (3.3%)	239 of 330 (72.4%)	1 of 330
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)	7 of 326 (2.1%)	201 of 326 (61.7%)	1 of 326
Cohort 1: Ad26.COV2.S (1*10^10 vp)	2 of 116 (1.7%)	75 of 116 (64.7%)	0 of 116
Cohort 2: Ad26.COV2.S (5*10^10 vp)	9 of 326 (2.8%)	294 of 326 (90.2%)	0 of 326
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)	4 of 328 (1.2%)	271 of 328 (82.6%)	0 of 328
Cohort 2: Ad26.COV2.S (1*10^10 vp)	2 of 106 (1.9%)	77 of 106 (72.6%)	0 of 106

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.
Derived from this study: PubMed 39121698Roels S, Bruckner M, Sadoff J, Cardenas V, Tang C, Hagedoorn S, Heerwegh D, Stieh DJ, Le Gars M. Pre- and post-Ad26.COV2.S booster dose antibody levels predict COVID-19 disease risk. Vaccine. 2024 Sep 17;42(22):126159. doi: 10.1016/j.vaccine.2024.126159. Epub 2024 Aug 8.
Derived from this study: PubMed 38918103Le Gars M, Sadoff J, Cardenas V, Heerwegh D, Tesfaye F, Roey GV, Spicer C, Matias SS, Crayne O, Kamphuis T, Struyf F, Schuitemaker H, Douoguih M. Safety, reactogenicity, and immunogenicity of Ad26.COV2.S as homologous or heterologous COVID-19 booster vaccination: Results of a randomized, double-blind, phase 2 trial. Vaccine. 2024 Jul 25;42(19):3938-3952. doi: 10.1016/j.vaccine.2024.03.079. Epub 2024 Jun 25.
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.

21 sites in 1 country: 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 Coronavirus Disease, run by Janssen Vaccines & Prevention B.V. at 21 sites in United States.

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 7 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 21 sites in United States. 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 5 Jan 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?

Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S (time frame: 14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15)). The study lists 16 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 NCT04999111, 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 4 Feb 2025.