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news.Novavax has initiated enrolment in Phase 2 randomised, blinded, placebo-controlled, dose-ranging trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age.
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The study, being conducted in collaboration with PATH that will fund approximately $2m to support the trial, will evaluate the immunogenicity and safety of two dose levels of Novavax’s RSV-F protein nanoparticle vaccine with and without aluminum phosphate as an adjuvant.
Novavax senior vice president and chief medical officer Gregory Glenn said the study will determine the optimal dosing regimen for future studies and the potential adjuvant effect of aluminum phosphate besides the evaluation of the safety and immunogenicity of RSV vaccine candidate in an important patient population.
"Previous clinical and preclinical findings have suggested that immunization with our nanoparticle vaccine produces functional neutralizing antibodies to multiple sites on the F protein," Glenn added.
"We expect to report top-line results from this trial, through Day 56 observations, in the first quarter of 2013."
The study will enroll around 330 women of childbearing age who will receive either one or two intramuscular injections at each dose level of vaccine or placebo at days 0 and 28.
According to the study design, the safety and immunogenicity will be evaluated over six and four month periods, respectively.