Novavax Says Phase I Clinical Trial Paper Published in Journal Vaccine

Novavax, Inc.

today announced that the journal Vaccine has published the company's data from its 2011 Phase I clinical trial of its respiratory syncytial virus (RSV) fusion (F) recombinant nanoparticle vaccine candidate. The paper was authored by a team of researchers and clinicians at Novavax and Dr. Pedro Piedra of Baylor College of Medicine. Findings from the trial were announced in October 2011 and presented in September 2012 by Novavax at the Respiratory Virus Symposium (RSV 2012) meeting in Santa Fe, New Mexico. The paper is currently available at www.novavax.com under Publications & Presentations/Publications and is expected to be published in the print edition shortly. Novavax had conducted the blinded, placebo-controlled, dose-escalating Phase I trial to assess the safety and tolerability of aluminum phosphate-adjuvanted and unadjuvanted formulations of its RSV vaccine candidate. A secondary objective of the study was to evaluate total and neutralizing anti-RSV antibody responses and assess the impact of the adjuvant. The authors reported that Novavax' vaccine was well-tolerated, with no evident dose-related toxicity or attributable severe adverse events. At day 60, both RSV A and B microneutralization titers were significantly increased in subjects treated with the Novavax vaccine versus placebo. The authors also reported a 7- to 19-fold increase in the anti-F IgG and a 7- to 24-fold increase in the levels of antigenic site II binding antibodies in vaccine recipients, as well as the induction of serum antibodies capable of competing with palivizumab, a humanized monoclonal antibody (mAb) with known protective efficacy against RSV disease in animals and humans.