Novavax RSV F Vaccine Phase 2 Clinical Trial Data in Women of Child Bearing Age Published in Vaccine
The manuscript describes the randomized, observer-blinded, placebo-controlled dose-ranging trial which evaluated the safety and immunogenicity of the RSV F Vaccine with and without varying doses of aluminum-phosphate adjuvant. The trial enrolled 720 women of child bearing age (18-35 years) at 10 clinical trial sites in
The manuscript documents the significant antibody response elicited by the RSV F Vaccine, including 11.6 to 12.7-fold increases in anti-F IgG responses in women receiving a single dose of 120 µg RSV F Vaccine with 0.2 or 0.4 mg of aluminum. These antibody responses peaked 14 days post-vaccination and persisted at significantly elevated levels for the 3 month period during which immunogenicity was evaluated. Palivizumab-competing antibody (PCA) levels were low or undetectable at day 0 but increased to 341-423 µg/mL on day 14 for the 120 µg 1-dose regimens. While baseline levels of RSV/A and RSV/B microneutralizing titers did not vary in the placebo group, they more than doubled at day 28 against both RSV strains for the 120 µg, 0.4 mg aluminum formulation, which the Company selected for further development.
Importantly, confirming results from the Company's prior trial in a similar population, serologic evidence of a new RSV infection by Western Blot was present in 21% (18/84) of placebo recipients, compared to only 10% (36/352) of vaccinees, a 52% (p=0.009) overall reduction of infection.
"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," said
Prepare is a global pivotal Phase 3 clinical trial of RSV F Vaccine candidate for the protection of infants via maternal immunization. The Prepare trial is a randomized, observer-blinded, placebo-controlled trial in healthy pregnant women. Participants are being vaccinated at a number of global clinical sites in advance of each region's RSV season.
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.1 In the US, RSV is the leading cause of hospitalization of infants, and globally, is second only to malaria as a cause of death in children under 1 year of age. 2,3 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.4,5 Currently, there is no approved RSV vaccine available.
Statements herein relating to the future of
Director, Investor Relations
1 Nair, H., et al., (2010) Lancet. 375:1545 - 1555
2 Hall, C.B. et al. (2013) Pediatrics; 132(2):E341-348
4 Glezen, W.P. et al. (1986) Am J Dis Child; 140:543-546
5 Glenn, G.M. et al. (2016) JID; 213(3):411-12
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