Oct 23 2015
Novavax, Inc., a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 2 rollover clinical trial of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in older adults enrolled in the prior Phase 2 trial.
The trial is a randomized, observer-blinded, placebo-controlled rollover trial designed to enroll the same 1600 adults 60 years of age and older (older adults) who participated in the recently concluded prior Phase 2 trial. Participants previously randomized to receive 135µg RSV F Vaccine or placebo will be re-enrolled and re-randomized in the current trial to receive either 135µg RSV F Vaccine or placebo. This will result in analysis of four separate study arms: a) participants receiving RSV F Vaccine in both the first trial and second trial; b) participants receiving placebo in the first trial and RSV F Vaccine in the second trial; c) participants receiving RSV F Vaccine in the first trial and placebo in the second trial; and d) participants receiving a placebo in both the first trial and second trial.
The primary endpoints of the trial will evaluate safety and serum anti-F IgG antibody concentrations in response to immunization with the RSV F Vaccine. Secondary endpoints will examine palivizumab-competing antibody (PCA) concentration and neutralizing antibody titer to at least one RSV/A and one RSV/B strain.
“It is estimated that 2.4 million adults 65 years of age or older are infected with RSV annually in the U.S., leading to as many as 900,000 medical interventions and 14,000 deaths each year,” said Stanley C. Erck, President and CEO. “This RSV F Vaccine rollover trial will provide important information on the amplitude and duration of immunogenicity in older adults, which will be a key data set as we develop the RSV F Vaccine for annual, seasonal vaccination.”
Source: http://www.novavax.com