Novavax has initiated a phase III study of its COVID-19 vaccine candidate in the UK, which will aim to enrol up to 10,000 volunteers.
The study will evaluate the efficacy, safety and immunogenicity of the vaccine, NVX-CoV2373, in individuals aged between 18-84, with and without relevant comorbidities.
The trial is being conducted in partnership with the UK government’s Vaccines Taskforce and is designed to enrol at least 25% of participants over the age of 65. It will also prioritise groups that are most affected by COVID-10, including racial and ethnic minorities.
Half the participants will receive two intramuscular injections of the vaccine, containing 5 µg of protein antigen with 50µg Matrix-M adjuvant, given 21 days apart, while the other half of the trial will receive placebo.
The trial has two primary endpoints, including first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least seven days after the second study vaccination in volunteers who have not been previously infected with the virus.
The second primary endpoint is first occurrence of PCR-confirmed symptomatic moderate-to-severe COVID-19 with onset at least seven days after the second study vaccination, again in volunteers who have not been previously infected with the virus.
The primary efficacy analysis will focus on event-driven analysis, based on the number of participants with symptomatic or moderate-to-severe COVID-19.
“With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal phase III clinical trial will enrol quickly and provide a near-term view of NVX-CoV2373’s efficacy,” said Gregory Glenn, president, Research and Development at Novavax.
“The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries,” he added.