Biotech company Novavax has announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the company’s Covid-19 vaccine candidate. Crossover ensures the administration of active vaccine to all participants in the trials and has begun for Novavax’ Phase IIb trial in South Africa and its pivotal Phase III trial in the UK.
Under Novavax’ updated clinical trial protocols, all participants in the UK and US Phase III trials will be offered the opportunity to receive an additional round of injections. Participants who elect to do so will receive an additional two-dose regimen of either vaccine (for those who originally received placebo) or placebo (for those who originally received vaccine). Participants in the South Africa Phase IIB trial will receive either active vaccine for those who initially received placebo, or a booster dose of active vaccine for those who initially received active vaccine. Participants across all three trials will remain blinded to the courses of treatment to preserve the ability to assess efficacy in each trial, and all will be followed for up to two years to monitor the safety and durability protection of the vaccine.
Filip Dubovsky, Chief Medical Officer, Novavax said: “The crossover arms ensure that all participants have access to an active vaccine candidate while allowing Novavax to continue to monitor the safety and efficacy of our vaccine over the long term”.
The company is also planning a crossover in the PREVENT-19 study, for which the company expects to read out initial clinical data during the second quarter. In addition, the company is planning to expand the trial to include paediatric and adolescent arms, which are also expected to begin in the second quarter.