Efficacy of Different COVID-19 Vaccine Combinations in Inducing Long-term Humoral Immunity [PRIBIVAC] (PRIBIVAC)
COVID-19
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Vaccine booster, SARS-CoV-2, Coronavirus, Antibody, Humoral immunity, Cellular immunity, Immunogenicity
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide informed consent for participation in this study;
- Aged ≥21years at the time of study enrolment;
- Received the second dose of BNT162b2 or mRNA-1273 Coronavirus Disease 2019 vaccines at least 6 months prior to enrolment;
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures.
Exclusion Criteria:
- Known history of SARS-CoV-2 or SARS-CoV-1 infection;
- Previously received an investigational coronavirus vaccine;
- Previously received a SARS-CoV-2 monoclonal antibody;
- Current or planned simultaneous participation in another interventional study;
- A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a COVID-19 vaccine, or otherwise have a contraindication to one of the available study vaccines per the approved label;
- Individuals who are immunocompromised (e.g. active leukaemia or lymphoma, generalised malignancy, aplastic anaemia, solid organ transplant, bone marrow transplant, current radiation therapy congenital immunodeficiency, HIV/AIDS with CD4 lymphocyte count < 200 and patients on immunosuppressant medications);
- Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids >/= 20 milligram per day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to Day 1;
- Individuals who are pregnant or breast feeding;
- Chronic illness that, in the opinion of the study team, is at a stage where it might interfere with trial conduct or completion;
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised involuntarily;
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures in the opinion of the study team;
- Moderate or severe acute illness/infection (according to study team's judgement) on the day of vaccination, or febrile illness (temperature ≥ 37.5°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
Sites / Locations
- National Centre for Infectious Diseases (NCID)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Experimental
Experimental
Experimental
Experimental
Homologous mRNA booster vaccine
Heterologous mRNA booster vaccine
Non-mRNA booster vaccine A
Non-mRNA booster vaccine B
Non-mRNA booster vaccine C
BNT162b2 + BNT162b2 + BNT162b2 or mRNA-1273 + mRNA-1273 + mRNA-1273
BNT162b2 + BNT162b2 + mRNA-1273 or mRNA-1273 + mRNA-1273 + BNT162b2
BNT162b2 + BNT162b2 + vaccine A or mRNA-1273 + mRNA-1273 + vaccine A
BNT162b2 + BNT162b2 + vaccine B or mRNA-1273 + mRNA-1273 + vaccine B
BNT162b2 + BNT162b2 + vaccine C or mRNA-1273 + mRNA-1273 + vaccine C