A treatment arm of up to 3000 participants aged 12-17 years old will be rolled into the North American-based PREVENT-19 trial.
Novavax will begin dosing children and adolescent participants in its ongoing phase 3 clinical trial assessment for NVX-CoV2373, the company’s investigative COVID-19 vaccine, for the prevention of the pandemic virus.
The biotechnology vaccine company announced on Monday morning that the North America-based PREVENT-19 pivotal trial will initiate a new treatment arm of up to 3000 adolescents aged 12-17 years old across 75 US sites. The younger participants will be included in the company’s assessment of NVX-CoV2373’s efficacy, safety, and immunogenicity against COVID-19.
New pediatric and adolescent patients will be split 2:1 to either NVX-CoV2373 or placebo across 2 doses, administered 21 days apart. The investigators intend to conduct a blind crossover 6 months after initiation to ensure all participants receive the active vaccine. Safety outcomes will be observed in participants for up to 2 years.
The investigative vaccine is currently being evaluated in a pair of pivotal phase 3 trials: PREVENT-19, and a UK trial which previously demonstrated 100% prevention against severe COVID-19, 96.4% efficacy against the original SARS-CoV-2 strain, 86.3% efficacy against the B.1.1.7 variant, and 89.7% efficacy overall.
Additionally, investigators have been conducting a pair of phase 2 studies since August 2020. The first has shown 100% prevention against severe disease and 48.6% efficacy against the South Africa variant, among South African participants. The second, a phase 1/2 continuation in the US and Australia, is ongoing.
PREVENT-19 was initiated in December 2020. Its early successes, as well as that of international studies, in adult participants lead Novavax to believe there’s significant hope for protecting children and adolescents from COVID-19.
"Through the expansion of our PREVENT-19 clinical trial, we hope to build upon the encouraging safety and efficacy data generated to-date in adults for our vaccine candidate and to play a significant global role in offering vaccination to as many people as possible across age groups to end the suffering caused by the pandemic," Gregory M. Glenn, MD, president of Research and Development at Novavax, said in a statement.