Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 Protein Vaccine.

ABSTRACT:

Background

COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern.

Methods

We conducted a global Phase 3, multi-stage efficacy study (NCT04904549) among adults aged ≥18 years. Participants were randomized 1:1 to receive two intramuscular injections 21 days apart of a bivalent SARS-CoV-2 recombinant protein vaccine with AS03-adjuvant (5 μg of ancestral (D614) and 5 μg of B.1.351 [beta] variant spike protein) or placebo. Symptomatic COVID-19 was defined as laboratory-confirmed COVID-19 with COVID-19-like illness (CLI) symptoms. The primary efficacy endpoint was the prevention of symptomatic COVID-19 ≥14 days after the second injection (post-dose 2 [PD2]).

Results

Between 19 Oct

SUBMITTER: Dayan GH 

PROVIDER: S-EPMC9753788 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature