Novavax, Inc. (NASDAQ:NVAX) has announced that data recorded from Phase II clinical trials for its RSV F vaccine have been published in the Vaccine journal.
The Phase II clinical trial data pertains to RSV F which was designed as a protein recombinant nanoparticle vaccine for women of child-bearing age. Additionally, the company allowed the data to be shared even before a reveal at any scientific conferences. The data is expected to be discussed in detail once the firm is ready to present it at an official conference soon.
The RSV F Vaccine looks promising
Novavax had previously announced positive results for the trials in 2014 and it is currently developing the drug with the aim of protecting infants from RSV disease. The Vaccine journal reveals details about the Observer-blinded, randomized, and placebo-controlled dose-ranging clinical trials. It sought to establish the safety of the RSV F vaccine with the presence and absence of different doses of aluminum-phosphate adjuvant.
Trials involved 720 female participants from the U.S., aged between 18 and 35 years. The trial was carried out at 10 different clinical trial locations and every participant received either one or two intramuscular injections of vaccine or placebo from the first day to the 28th day. According to the publication, there was significant antibody response caused by the RSV F vaccine. This includes 11.6 to 12.7-fold increases in anti-F IgG responses for the patients receiving a single dose of 120 µg together with 0.2 or 0.4 mg of aluminum.
The highest levels of antibody responses were recorded 14 days after vaccination. They also continued to demonstrate significantly elevated levels throughout the three months that the trial was carried out. Palivizumab-competing antibody (PCA) were reportedly very low during the first day of the drug trials but they increased to 341-423 µg/mL on the 14th day for those under the 120 µg 1-dose regimens. RSV/A and RSV/B microneutralizing titers did not show varying baseline levels in the placebo group though they more than doubled on the 28th day for the 20 µg, 0.4 mg aluminum formulation.
Novavax stock closed the latest trading session on Wednesday at $1.05.