Novavax RSV F Vaccine Clinical Trial Data in Women of Child Bearing Age Published in the Journal of Infectious Disease

GAITHERSBURG, Md., Sept. 10, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that the full data set from its clinical trial of the RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in women of childbearing age (18-35 years) were published in the Journal of Infectious Disease. The Company previously announced top-line results from the trial.

The manuscript describes the randomized, blinded, placebo-controlled Phase 2 clinical trial that evaluated the safety and immunogenicity of two dose levels of the RSV F Vaccine with and without aluminum phosphate adjuvant. The trial enrolled 330 women of childbearing age who received either one or two intramuscular injections of a single-dose (60 or 90 µg) of vaccine or placebo at study days 0 and 28.

The manuscript details the significant antibody response to the RSV F Vaccine including a 6.5-15.6-fold increase in anti-F IgG antibodies across all vaccine doses at day 56, with significantly higher levels in the two-dose adjuvanted regimens. Palivizumab-competing antibody (PCA) levels were undetectable at day 0 but increased up to between 205-325 µg/mL at day 56. Further, a 2.7 and 3.5-fold rise in RSV/A and RSV/B microneutralizing antibodies were detected at day 56, prior to the RSV season. Finally, between days 56 and 112, 21% (12/56) of placebo recipients showed evidence of a recent RSV infection by Western Blot compared to 11% of vaccinees (26/244) (p = 0.04). 

"These data are the foundation for our ongoing RSV F Vaccine development program to protect infants via maternal immunization," said Gregory Glenn, M.D., Senior Vice President of Research and Development. "The RSV F Vaccine stimulated high levels of anti-F, PCA and microneutralizing antibodies. Further, our ad hoc analysis via Western Blot, together with our recent data in older adults, provides an additional indication that the vaccine-induced immunity can protect against RSV infections in humans. We look forward to announcing additional data from our trial of the RSV F Vaccine in pregnant women later this quarter, a key milestone in our strategy to develop a vaccine designed to protect infants via maternal immunization."