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

NCT04999111 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CR109060VAC31518COV2008
• Study Type: interventional
• Target: 1,541
• Locations: 1 country
• Sites: 21

Brief Summary

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

Outcome Measures

Primary Outcomes (16)

• 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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  From booster vaccination (Day 1) until 1 year post booster vaccination

Study Arms (6)

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.

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.

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.

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.

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.

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.

Biological: Ad26.COV2.S

Interventions

Ad26.COV2.S BIOLOGICAL

Participants will receive IM injection of Ad26.COV2.S.

Also known as: JNJ-78436735, VAC31518

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (21)

Central Phoenix Medical Clinic

Phoenix, Arizona, 85020, United States

Location

Synexus Clinical Research US Inc

Tucson, Arizona, 85741, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Ark Clinical Research

Long Beach, California, 90815, United States

Location

Velocity Clinical Research

North Hollywood, California, 91606, United States

Location

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States

Location

Research Centers of America, LLC

Hollywood, Florida, 33024, United States

Location

Synexus Clinical Research US Inc

Orlando, Florida, 32806, United States

Location

Synexus Clinical Research US Inc

The Villages, Florida, 32162, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Clinical Trials Management, LLC

Metairie, Louisiana, 70006, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Velocity Clinical Research, Anderson

Anderson, South Carolina, 29621, United States

Location

Accellacare US Inc

Mt. Pleasant, South Carolina, 29464, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Crofoot Research Center

Houston, Texas, 77098, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Related Publications (2)

• 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.

  PMID: 39121698 DERIVED

• 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.

  PMID: 38918103 DERIVED

MeSH Terms

Interventions

Ad26COVS1

Intervention Hierarchy (Ancestors)

COVID-19 Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: SENIOR ADVISOR CLINICAL DEVELOPMENT
• Organization: Janssen R&D US

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 10, 2021
• Study Start: August 6, 2021
• Primary Completion: October 27, 2021
• Study Completion: November 22, 2022
• Last Updated: February 4, 2025
• Results First Posted: January 5, 2023

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (21)