DGAP-News

Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing Age

DGAP-News: Novavax, Inc. /
Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase
2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing
Age

28.04.2014 / 22:18

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-- Vaccine candidate was well-tolerated with no vaccine-related serious
adverse events
-- Highest immune responses observed with a single dose of vaccine combined
with aluminum phosphate adjuvant
-- Women with the lowest baseline levels of RSV neutralizing antibodies had
the largest increases following immunization, consistent with prior data
-- Palivizumab-like antibodies exceeded levels observed in previous trials
-- High levels of antibodies developed within 14 days after immunization and
persisted over the 91-day observation period
-- Data permit selection of vaccine formulation and regimen for planned Phase
2 clinical trial in pregnant women

GAITHERSBURG, Md., April 28, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc.
(Nasdaq:NVAX) today announced positive top-line safety and immunogenicity data
from its RSV-F protein nanoparticle vaccine candidate in a Phase 2 clinical
trial in women of childbearing age. The randomized, blinded, placebo-controlled
Phase 2 study was designed to evaluate the immunogenicity and safety of
multiple formulations of Novavax' RSV-F protein nanoparticle vaccine adjuvanted
with aluminum phosphate. The primary outcome of the trial was safety and immune
response (measured by levels of serum IgG antibody specific for the F protein).
The study enrolled 720 healthy women between the ages of 18 and 35 years, who
received either one or two intramuscular injections featuring two different
dose levels of vaccine antigen with a range of doses of aluminum phosphate
adjuvant. These top-line data relate to the safety and immunogenicity over the
91-day period following first immunization and support Novavax' maternal
immunization strategy.

Highlights of the interim results:

-- The RSV-F vaccine candidate was well-tolerated, with no vaccine-related
serious adverse events, at all doses and formulations. The safety profile
was consistent with data from prior Phase 1 and 2 studies.
-- Significant increases in RSV-F antibody levels were observed across all
doses and formulations, consistent with prior studies. Peak RSV-F antibody
levels were observed in the group that received a single dose of vaccine
containing 120 ug of antigen with one-third of the aluminum phosphate dose
used in prior studies.