A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
Condition: Coronavirus Disease
MeSH terms: Coronavirus Infections
Intervention: Ad26.COV2.S
Intervention description: Participants will receive IM injection of Ad26.COV2.S.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1541.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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