Novavax have reported positive results of a Phase II clinical trial of its respiratory syncytial virus (RSV) vaccine candidate as a maternal immunization strategy. Novavax say that the randomized, blinded, placebo-controlled, dose-ranging Phase II clinical trial of the RSV F protein nanoparticle vaccine candidate accomplished the trial's protocol-specified objectives and supports progression to the next stage.
Maternal immunization is a strategy that can be used to protect infants from infectious diseases, as vaccine-induced maternal antibodies cross the placenta into the foetus. Such a strategy could be used for protecting infants against RSV, which is a common cause of childhood respiratory infection and causes approximately 160,000 deaths annually.
330 women of childbearing age were enrolled in the study which evaluated the safety and immunogenicity of the vaccine with and without alum adjuvant. The results showed that the vaccine candidate was generally well-tolerated, with a similar safety profile to the Phase I clinical trial.
"These results confirm that our RSV vaccine candidate has the potential to induce clinically useful immunity and has raised no safety concerns. The primary immunogenicity measures confirmed that the vaccine is a potent antigen and the aluminum phosphate adjuvant further enhanced the antibody responses. The results answered key questions regarding dose regimens and the use of aluminum phosphate as adjuvant," said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax in a press release. "With respect to secondary and exploratory objectives, we also observed that the vaccine induced peak neutralizing antibodies in excess of those seen in our Phase I trial, as well as reproducing palivizumab-like antibody responses. Neutralizing antibodies have been associated with decreased risk of hospitalization in infants and palivizumab is a licensed monoclonal antibody, marketed as SynagisÂ®, that is used to prevent high-risk infant hospitalization due to RSV. The findings from this clinical trial indicate that our RSV F vaccine candidate has the potential to induce functional immune responses at levels that would be predicted to protect infants through maternal immunization. Overall, we are buoyed by these data and believe these findings warrant the pursuit of later-stage clinical trials."
The trial is being conducted in collaboration with PATH.
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See the Novavax press release. Read more about RSV vaccine development: Respiratory syncytial virus (RSV): Potential significant opportunity for effective vaccine