Novavax, Inc. 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.
In this trial, the vaccine candidate was generally well-tolerated and the
safety profile was similar to that observed previously in the Phase I clinical
trial. The principal observation was transient mild to moderate injection site
pain, predictably somewhat more frequent in the adjuvanted vaccine recipients.
There were no clinically important differences in systemic adverse events
between placebo and active vaccine recipients and no vaccine related SAEs. The
most commonly reported systemic reactogenicity was comprised mainly of mild to
moderate headache, fatigue and muscle ache, which are frequently noted after
treatment by many vaccines. There were no differences in safety assessments
across doses (60 and 90 µg) or worsening of reactogenicity with a second-dose.
Laboratory testing did not reveal clinically significant changes in normal
blood chemistries or hematology parameters.
The primary objectives of the study measured the difference in anti-F IgG
elicited by the use of alum adjuvant, one versus two immunizations, and across
doses (60 and 90 µg). The use of alum enhanced both the single and two-dose
regimen anti-F IgG responses, with the greatest responses observed using a
two-dose regimen. Peak geometric mean titers of anti-F IgG in the two-dose
alum groups ranged from 12,000-14,000 representing a 13 to 16-fold rise,
compared to a 6 to 10-fold rise in the non-alum groups. Minimal increases were
observed by increasing the doses (60 to 90 µg). Peak geometric mean RSV A
neutralizing antibodies in the alum groups ranged from log[2] 9.5-10.5,
representing a 3.1 to 3.8-fold rise. Palivizumab-like antibody titers rose 8
to 9-fold, with four-fold rises in ≥92% of vaccinees in the two-dose alum
adjuvanted vaccine groups. Overall, the immune responses observed in this
Phase II clinical trial were similar to, or exceeded immune responses seen in
the Phase I clinical trial using the Novavax nanoparticle vaccine.
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