At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Heterologous Prime-boost-boost Vaccine Combinations for Long-term Humoral and Cellular Immunity Against COVID-19
In Brief
A Phase 4 clinical trial evaluating Homologous mRNA booster vaccine, Heterologous mRNA booster vaccine, and 2 other interventions for COVID-19. Completed, enrolled 326 participants across 1 site.
Detailed 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'.
Study Details
Timeline
Interventions
Single intradermal injection. The vaccine dose will be according to manufacturer's instructions.
Single intradermal injection. The vaccine dose will be according to manufacturer's instructions.
Single intradermal injection at 6ug (0.5ml) per dose.
Single intradermal injection at 5mcg (0.5mL) per dose.