Novavax releases data from Phase 2 of maternal vaccination clinical trial
The new vaccine is indicated for the protection of infants via maternal vaccination. The third phase of the clinical trial, which will be administered to pregnant women, will be funded through a grant of up to $89 million awarded to Novavax by the Bill & Melinda Gates Foundation.
That phase is set to start in the first quarter of 2016.
The goal of the Phase 2 trial was to determine the safety and immunogenicity of the RSV F Vaccine in healthy pregnant women as well as to evaluate 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.
"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," Gregory Glenn, senior vice president for research and development, said.
Novavax CEO and President Stanley Erck agreed.
"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," he said. "We look forward to advancing our maternal immunization program to a Phase 3 clinical trial with the support of the Bill & Melinda Gates Foundation."
Additional information about Novavax is available at www.novavax.com.