Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19.

ABSTRACT:

Background

The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation.

Methods

In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×10¹⁰ viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed.

SUBMITTER: Sadoff J 

PROVIDER: S-EPMC8220996 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature