Phase II trial starts for NVX CoV2373 in COVID-19.- Novavax

Novavax announced that the first volunteers have been enrolled in the Phase II portion of its ongoing clinical trial to evaluate the immunogenicity and safety of NVX CoV2373, Novavax’ COVID-19 vaccine candidate. The Phase II clinical trial expands on the age range of the Phase I portion by including older adults 60-84 years of age as approximately 50 percent of the trial’s population. NVX CoV2373 is a stable, prefusion protein made using Novavax nanoparticle technology and includes Novavax proprietary Matrix-M adjuvant. The Phase II portion of the ongoing Phase I/II clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the safety and immunogenicity of NVX CoV2373 with Matrix-M in subjects aged 18 to 84 years. The clinical trial will assess two dose sizes (5 and 25 microg), each with 50 microg of Matrix-M. Although the trial was designed to confirm immunogenicity and safety in adults, secondary objectives include preliminary evaluation of efficacy. The study is targeting enrollment of up to 1,500 healthy volunteers, with approximately 50 percent of participants at least 60 years of age, at up to 40 sites in the U.S. and Australia. The trial is supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI). In the Phase I portion of the Phase I/II clinical trial, conducted in Australia, NVX CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. These data have been submitted for peer-review to a scientific journal.