An international randomised trial of candidate vaccines against COVID-19

Overview

This large, international, randomized controlled clinical trial is designed to enable an expeditious, agile and concurrent evaluation of the benefits and risks of multiple candidate preventive vaccines against COVID-19 at international sites with sufficient COVID-19 attack rates. Different candidate vaccines may be available or suitable to enter the trial at different times; for each candidate vaccine, the primary efficacy results are expected within 3-6 months of the vaccine entering the trial.

The trial will rapidly enroll and individually randomize very large numbers of adult participants in many different populations. Each participant will be contacted weekly for information as to whether any potentially relevant symptoms have arisen, with laboratory testing triggered if the report suggests COVID-19. By using a shared placebo/control group and a common Core protocol to evaluate multiple candidate vaccines in the trial, resources allocated to the evaluation of each candidate vaccine are judiciously saved while a high standard of scientific rigor and efficiency is ensured.

The trial is powered to provide sufficient evidence of safety and vaccine efficacy against COVID-19 to support decision-making about global vaccine deployment.