SATURDAY, OCTOBER 1, 2016

Phase 2 trial of Novavax RSV vaccine candidate begins

Novavax announced on Monday that it has begun enrollment for its Phase 2 clinical trial of its respiratory syncytial virus vaccine candidate.

The vaccine, targeted at women of childbearing age, will be distributed in a randomized, blinded, placebo-controlled Phase 2 study, which is meant to evaluate the immunogenicity and safety of numerous formulations of Novavax' RSV-F protein nanoparticle candidate with aluminum phosphate as an adjuvant. The study looks to enroll 720 women who will either be given one or two intramuscular injections at both dose levels of the vaccine, or a placebo at days 0 and 28. The results will be evaluated over three month and six month periods, respectively.

"This trial represents important progress for our RSV vaccine, which is being developed to protect young infants through maternal immunization," Gregory Glenn, the senior vice president and chief medical officer of Novavax, said. "This study will help define the dose and dose regimen and expand the safety database for our maternal immunization strategy. These are all essential steps in the advancement of this important vaccine towards licensure."

Novavax is a clinical-stage biopharmaceutical company that makes novel vaccines and vaccine adjuvants to deal with numerous infectious diseases around the world.