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Novavax Phase 3 COVID-19 vaccine trial completes enrollment in two months

 

The NIHR-supported Novavax Phase 3 COVID-19 vaccine trial has achieved its recruitment target just two months after opening in the UK - with 15,203 volunteers from across the country recruited in record time.

The Novavax study is now the largest double blind, placebo-controlled COVID-19 vaccine trial to be undertaken in the UK so far.

The pivotal phase 3 trial to determine efficacy and safety of the Novavax vaccine candidate opened in the UK on 23 September and is now closed to further recruitment having fully enrolled, ahead of schedule. The final study participant enrolled on Saturday 28 November.

The UK Vaccines Taskforce and National Institute for Health Research (NIHR) have played vital roles in the rapid recruitment and enrollment of volunteers.

A significant proportion of participants taking part in the study were recruited through the new NHS COVID-19 Vaccine Research Registry - an online registry of people who have signed-up to be contacted about taking part in COVID-19 vaccine studies. While the NIHR’s new National Patient Recruitment Centres also played a key role in recruiting and dosing study participants at three regionally based NHS sites across England.

The UK was the first country in the world to undertake and deliver a phase 3 trial for the Novavax vaccine. A phase 2b trial is currently underway in South Africa - with 4,422 volunteers taking part. While Novavax expects its pivotal phase 3 clinical trial in the United States and Mexico to begin in the coming weeks. In total, nearly 20,000 participants around the world have already been dosed.

The Novavax trial is investigating the safety, efficacy and immunogenicity of NVX-CoV2373 - a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix‑M™.

The UK phase 3 trial is a randomised, placebo-controlled, observer-blinded trial during which 50% of volunteers will be given two intramuscular injections of the vaccine candidate, 21 days apart, while the remaining will receive placebo.

More than 25 percent of enrollees in the trial are over the age of 65, while a large proportion of volunteers had underlying medical conditions generally representative of the population.

Interim data from this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. These data are expected to serve as the basis for licensure application in the U.K., European Union and other countries.

The UK government has already secured 60 million doses of the Novavax NVX-CoV2373 vaccine, provided it meets standards on safety, effectiveness and quality following publication of results.

Professor Paul Heath, Chief Investigator of the Novavax Phase 3 vaccine trial in the UK said:

"The speed at which this important trial was conducted was a huge challenge but the NIHR sites stepped up and delivered this in an efficient and professional manner. We believe this is the largest randomised, double blind, placebo-controlled vaccine trial yet done in the UK and as a team we now look forward to bringing this trial to a successful conclusion.”

Gregory M. Glenn, MD, President of R&D, Novavax said:

“Completion of enrollment in this Phase 3 clinical trial is a significant achievement and important step in our ability to demonstrate how well NVX-CoV2373 works to prevent COVID-19.

“We are grateful to the professional and dedicated staff across the many NHS sites for their work to advance this trial, as well as the thousands of volunteers who stepped forward to participate in this critical research.”

Read more about NIHR COVID-19 research