Efficacy of Different COVID-19 Vaccine Combinations in Inducing Long-term Humoral Immunity [PRIBI… (NCT05142319) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Different COVID-19 Vaccine Combinations in Inducing Long-term Humoral Immunity [PRIBIVAC]
Singapore326 participantsStarted 2021-10-12
Plain-language summary
PRIBIVAC will assess a heterologous prime-boost-boost strategy in comparison with a homologous regimen in order to compare short and long-term immunogenicity of different COVID-19 vaccine combinations against the ancestral SARS-CoV-2 as well as different variants of concern (VOCs). Initial phases of the study (Phases A-C) have studied homologous versus heterologous vaccines at the first booster, later phases (Phase D) will study these as the second booster.
Hypothesis: One or more heterologous prime-boost-boost COVID-19 vaccine combinations will produce humoral and cellular immunity that is non-inferior to an homologous prime-boost-boost vaccination against wildtype SARS-CoV-2 and/or 1≥ VOC. In Phases A-C of the study the primary 2 dose mRNA vaccine series was defined as 'Prime-boost'. For phase D we will define these 2 doses as 'Prime' and the 3rd vaccine dose as 'Boost'.
Who can participate
Age range21 Years
SexALL
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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;