Candidate RSV Vaccine Passes Safety and Efficacy Study

The effort to develop a vaccine to protect children and the elderly from respiratory syncytial virus (RSV) passed a major milestone with the successful completion of a preclinical safety and efficacy study.

The recombinant F-protein (fusion protein) candidate vaccine was produced by the biotechnology company Novavax Inc. (Rockville, MD, USA). Novavax is a clinical-stage biotechnology company creating novel vaccines using advanced proprietary virus-like-particle (VLP) technology.

In the current study, conducted on the well-known cotton rat model of RSV, investigators at Novavax vaccinated the animals with 1 μg, 6 μg, or 30 μg of the candidate RSV-F vaccine on days 1 and 21. Some of the animals received the vaccine with an alum adjuvant.

Results of the experiment showed that all dose groups produced antibodies that neutralized RSV, and with adjuvant, only a single injection of RSV-F was needed to induce high levels of neutralizing antibodies.

In a challenge, study animals that had not been vaccinated displayed high levels of virus in their lungs, while no RSV was detected in the lungs of animals immunized with any dose of the Novavax RSV-F vaccine, with or without adjuvant.

"We are excited to report steady progress towards the development of a vaccine against RSV, an important virus that is the leading cause of viral death in infants," said Dr. Rahul Singhvi, president and CEO of Novavax. "A safe and effective vaccine against RSV is especially needed in very young children since RSV infection does not provoke lasting immunity. An effective vaccine would also be important in adults, especially the elderly, where RSV illness is common. There is currently no approved vaccine for the prevention of RSV and the market potential for such a vaccine could exceed $1 billion annually."

Complementing the successful safety study, the successful scale up of the manufacturing process for the RSV-F vaccine candidate was announced. Vaccine produced with this process is currently being used in a formal toxicology study in rabbits.

Related Links:
Novavax Inc.