Novavax Announces Positive Top-Line Data from Phase 2 Clinical Trial of RSV F Vaccine to Protect Infants via Maternal Immunization
The purpose of the Phase 2 trial was to evaluate the safety and immunogenicity of the RSV F Vaccine in healthy pregnant women. The trial also assessed the transplacental transfer of maternal antibodies induced by the vaccine, the impact of maternal immunization on infant safety during the first year of life and RSV-specific antibody levels through the infants' first six months of life.
The trial was a randomized, blinded, placebo-controlled Phase 2 trial which enrolled 50 healthy pregnant women in their third trimester. Women were randomized to receive either placebo or 120 micrograms of RSV F Vaccine adjuvanted with 0.4 mg of aluminum phosphate. They were followed through the remainder of their pregnancies, delivery and for an additional 180 days postpartum to assess safety and immunogenicity as measured by serum RSV anti-F IgG, microneutralizing, and palivizumab-competing antibody (PCA) titers. Upon delivery, umbilical cord blood samples were obtained to determine the titers of RSV PCA, anti-F IgG, and microneutralizing titers in their infants. Additional serum samples from the infant participants were obtained over the following six month period to provide a preliminary estimate of the half-life of vaccine-induced maternal antibodies.
Women in the vaccinated group demonstrated a geometric mean 14-fold rise in anti-F IgG, 29-fold rise in PCA, and 2-fold rise in microneutralization titers. In contrast, women who received placebo demonstrated no significant change in their antibody levels. At delivery, the geometric mean anti-F IgG antibody titer in immunized women was 7,244 Elisa Units (EU) and on average, the infants' antibody titer equaled 100% of the mothers' anti-F IgG antibody titer. The geometric mean PCA antibody titer was 212 micrograms/mL in immunized mothers and the average PCA antibody transfer within the mother-infant pairs was 90%. Finally, geometric mean microneutralizing antibody titers in immunized mothers were 759 and 481 micrograms/mL for RSV/A and RSV/B respectively, and the average microneutralizing antibody transfer within the mother-infant pairs was 90% for RSV/A and 100% for RSV/B. The estimated half-lives of infant PCA, anti-F IgG, RSV/A and RSV/B microneutralizing antibodies, based on data through day 60, were 41, 30, 36 and 34 days, respectively.
"Maternal immunization is an elegant and accepted approach to protect infants in the first few months of life, the time period when they are most vulnerable to RSV," said
"These data illustrate the promise of our RSV F Vaccine to protect infants via maternal immunization, demonstrating robust immune responses in women with antibody transfer to infants. We look forward to advancing our maternal immunization program to a Phase 3 clinical trial with the support of the
A fact sheet on maternal immunization is available at the
About RSV
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, respectively1. In the US, RSV is the leading cause of hospitalization of infants2. Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common3,4. Currently, there is no approved RSV vaccine available. Palivizumab is a monoclonal antibody, licensed and sold by MedImmune as Synagis®, that targets the RSV F protein and is used for prophylaxis against RSV disease in high risk infants.
About
References:
- Nair, H. et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet, 2010; 375: 1545-1555.
- Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.
- Glezen, W.P. et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546.
- Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine, 2015; In press. http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
Contact: | Novavax, Inc. |
Barclay A. Phillips | |
SVP, Chief Financial Officer and Treasurer | |
Andrea N. Flynn, Ph.D. | |
Senior Manager, Investor Relations | |
240-268-2000 | |
Russo Partners, LLC | |
David Schull | |
Todd Davenport, Ph.D. | |
212-845-4271 |
Photo - http://photos.prnewswire.com/prnh/20150925/271009
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/novavax-announces-positive-top-line-data-from-phase-2-clinical-trial-of-rsv-f-vaccine-to-protect-infants-via-maternal-immunization-300149808.html
SOURCE