Novavax to Evaluate its Vaccine Against Respiratory Syncytial Virus

Novavax, Inc. (Rockville, MD) has begun patient enrollment in a Phase 1 clinical trial to assess the safety, immunogenicity, and tolerability of a vaccine candidate against respiratory syncytial virus (RSV). In this blinded, placebo-controlled, escalating-dose study of healthy adults 18 to 49 years old, a total of 100 subjects will be allocated to four cohorts and randomized to receive vaccine treatment or saline placebo in a 4:1 ratio. It is expected that interim data from the trial will be available in the third quarter of 2011.

Novavax has evaluated its RSV vaccine candidate in well-accepted animal models of toxicity and disease and found it to be safe at all doses tested. Preclinical results have shown induction of neutralizing antibodies and protection from RSV challenge with no disease enhancement and no detection of disease in any of the animals immunized with the vaccine at any dose level tested. Novavax's vaccine uses highly purified recombinant particles of RSV-F fusion protein normally found in the virus.

There are no vaccines currently approved for RSV disease, which is the most important viral cause of lower respiratory tract infection in infants and children worldwide and is a major cause of respiratory illness in elderly adult. The global disease burden is estimated at 64 million cases and 160,000 deaths every year.