Novavax, Inc. (Nasdaq:NVAX) announced on 5/7/18 it has reached a significant milestone in the Prepare Phase 3 clinical trial of its respiratory syncytial virus F protein recombinant nanoparticle vaccine (RSV F Vaccine) for infants via maternal immunization. Enrollment has reached approximately 4,600 participants, of whom, at least 3,000 have received the RSV F Vaccine.
Prepare is a global, pivotal Phase 3 clinical trial of the RSV F Vaccine, in healthy, third trimester pregnant women, which initiated in December 2015. The primary objective of the Prepare trial is to determine the efficacy of maternal immunization with the RSV F Vaccine against medically significant RSV-positive lower respiratory tract infection (LRTI) in infants through a minimum of the first 90 days of life and up through the first six months of life.
“Reaching this enrollment target for the Prepare trial is a significant milestone in the advancement of our RSV F Vaccine franchise,” said Stanley C. Erck, President and CEO of Novavax, Inc. “RSV remains an urgent global unmet medical need due to the mortality and morbidity associated with RSV disease in infants and the absence of a vaccine to prevent such disease. We look forward to completing the interim analysis of the Prepare trial as this is the next step on the path to filing marketing applications in the U.S. and Europe for the first-ever RSV vaccine.”
The Prepare trial is supported by a grant of up to $89.1 million from the Bill & Melinda Gates Fund. This grant supports development activities, product licensing efforts and World Health Organization pre-qualification of the RSV F Vaccine.
The FDA has granted the RSV F Vaccine fast track status and it could potentially be eligible for priority review. Novavax expects to report on interim data in early 2019. Assuming successful interim analysis results, the trial would be concluded without further enrollment and Novavax would file a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) with the European Medicines Agency (EMA) by the first quarter of 2020.
In 2016 Novavax released disappointing results of a Ph III study of the RSV F vaccine in older adults. In the Resolve trial, the vaccine failed to reach primary or secondary efficacy objectives.
