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

Purpose

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.

Condition

  • Coronavirus Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Group 1: Ad26.COV2.S (Dose Level 1) 		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
    Participants will receive IM injection of Ad26.COV2.S.
    Other names:
    • JNJ-78436735
    • VAC31518
Experimental
Cohort 1: Group 2: Ad26.COV2.S (Dose Level 2) 		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
    Participants will receive IM injection of Ad26.COV2.S.
    Other names:
    • JNJ-78436735
    • VAC31518
Experimental
Cohort 1: Group 3: Ad26.COV2.S (Dose Level 3) 		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
    Participants will receive IM injection of Ad26.COV2.S.
    Other names:
    • JNJ-78436735
    • VAC31518
Experimental
Cohort 2: Group 4: Ad26.COV2.S (Dose Level 1) 		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
    Participants will receive IM injection of Ad26.COV2.S.
    Other names:
    • JNJ-78436735
    • VAC31518
Experimental
Cohort 2: Group 5: Ad26.COV2.S (Dose Level 2) 		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
    Participants will receive IM injection of Ad26.COV2.S.
    Other names:
    • JNJ-78436735
    • VAC31518
Experimental
Cohort 2: Group 6: Ad26.COV2.S (Dose Level 3) 		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
    Participants will receive IM injection of Ad26.COV2.S.
    Other names:
    • JNJ-78436735
    • VAC31518

Recruiting Locations

More Details

NCT ID
NCT04999111
Status
Completed
Sponsor
Janssen Vaccines & Prevention B.V.