Novavax’s nanomedicine vaccine is being developed to protect infants from the respiratory syncytial virus. The Gaithersburg, Md.-based company presented top-line data from the Phase II trial in April 2014.
The randomized trial, which enrolled 720 women ages 18 to 35, assessed the safety and immunogenicity of the vaccine with and without varying doses of aluminum-phosphate adjuvant. Participants received either 1 or 2 intramuscular injections of vaccine or placebo at days 0 and 28.
The researchers observed that the vaccine prompted a significant antibody response, which peaked 14 days post-vaccination and persisted during the 3 month study period.
The team also confirmed results from the company’s previous trial using Western Blot – serologic evidence of a new RSV infection was present in 21% of patients in the placebo group compared to just 10% of the group that was vaccinated.
“The Western Blot finding from this trial, which demonstrates a reduction in recent RSV infections of approximately 52% in the vaccine relative to the placebo arms, is consistent with the Western Blot data we reported from a comparable trial and population in September of 2015. Together, these data suggest that the RSV F Vaccine provided protection against RSV infection in controlled trials of over 1,000 women,” president of R&D Dr. Gregory Glenn said in prepared remarks. “The results from this trial not only demonstrate significant increases in anti-F IgG, PCA and microneutralizing antibody titers in response to a 120 µg dose of the RSV F Vaccine with 0.4 mg aluminum, the same dose and regimen used in our global Phase 3 trial, Prepare, they are consistent with the immunogenicity results reported in our prior trial in women of child bearing age. While it was not the primary endpoint in the trial, the Western Blot data suggest the potential to protect both the pregnant mothers and their infants from RSV disease.”
NVAX shares were trading at $1.09 apiece in afternoon activity today, up 7%.