By Gary Thomas
Novavax, the biopharmaceutical company that develops vaccines for a range of diseases, announced that its Senior Vice President and Chief Medical Officer, Gregory Glenn, M.D., presented the findings of the preclinical and clinical study for Novavax’s respiratory syncytial virus (RSV) vaccine development program at the first conference on Modern Vaccines Adjuvants and Delivery Systems at Copenhagen in Denmark.
Dr. Glenn reported that the results of the recently concluded Phase I trial were aligned with the results from the preclinical study carried out on pertinent animal models. This reportedly demonstrates that Novavax’s Fusion (F) protein nanoparticle RSV vaccine is immunogenic, well tolerated and generates functional antibodies capable of neutralizing the virus. RSV is the leading source of pneumonia in adults and the leading source of pneumonia and bronchiolitis in children less than a year old. The development of an RSV vaccine is a challenge and to date, there are no known vaccines for the prevention of RSV infection.
The data from the preclinical and clinical studies provided insight into RSV infection that could greatly aid the synthesis of suitable vaccines. It was found that while subjects with RSV infection showed the presence of anti F-antibodies, specific antigenic sites on the Fusion (F) protein of RSV, labeled as site II showed no presence of the antibodies. Clinical studies revealed that antibodies like palivizumab (trade name Synagis), which is already in use around the world for RSV disease prevention in premature babies, proved to be very effective in RSV prevention. The Novavax RSV F nanoparticle vaccine contains numerous copies of the antigenic site II epitope. Preclinical studies on cotton rats show that the vaccine induced anti-RSV IgG offers protection against the virus. The administration of the vaccine to healthy adults in the Phase I placebo-controlled trial also showed promising results, making the RSV F nanoparticle vaccine a promising candidate for protection against RSV infection.