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Well-tolerated and without any vaccine related serious adverse events (SAEs)
Anti-F IgG antibodies to the F protein in serum rose 6 to 16-fold across all doses (60 and 90 µg). Addition of adjuvant enhanced response with both first and second vaccinations
Neutralizing antibody responses were seen with both doses and with a similar magnitude following first or second vaccinations
Data provides basis for ongoing development of an RSV vaccine
Conference call/webcast Wednesday, April 3 rd at 10:00 am EDT
ROCKVILLE, Md., April 2, 2013 (GLOBE NEWSWIRE)
-- Novavax, Inc. (Nasdaq:NVAX)
today announced that top-line data from the Phase II dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age accomplished the trial's protocol-specified objectives and supports progression to the next stage of advanced clinical testing. The trial represents an important step towards establishing the safety and immunogenicity of the vaccine candidate for use in a maternal immunization strategy. In such a strategy, the antibodies in vaccinated women can be expected to be naturally transferred to their infants in utero and thereby may confer passive protection at the earliest stage of life when these infants are extremely vulnerable to severe respiratory disease due to RSV.
This randomized, blinded, placebo-controlled Phase II clinical trial evaluated the safety and immunogenicity of two-dose levels of Novavax' RSV F protein nanoparticle vaccine candidate with and without aluminum phosphate (alum) as an adjuvant. The study enrolled 330 women of childbearing age who received either one or two intramuscular injections of a single-dose of vaccine or placebo, at study day 0 and day 28. Doses of 60 and 90 µg were tested, either with or without alum as an adjuvant. Safety and immunogenicity data for this clinical trial have been evaluated through day 56. Safety will continue to be evaluated over a total period of six months and immunogenicity for four months for each participant. The clinical trial is being conducted in collaboration with PATH, an international nonprofit organization that transforms global health through innovation. PATH committed funding of approximately $2 million to support this trial with the aim of advancing the development of an RSV vaccine to protect infants through maternal immunization in low-resource countries.