Recently, Novavax (NASDAQ:NVAX) announced final results from a phase II trial of its trivalent seasonal influenza Virus-like particle [VLP] vaccine in adults 18-49 years of age. Initial results from the trial were reported in 2009.
The initial analysis carried out on 190 people (aged 18 to 49 years) showed strong immune system responses against three flu strains (H3N2, H1N1 and B) without any major adverse events.
The complete study was conducted on 232 people out of whom 49 were on placebo while 19 received another trivalent influenza vaccine Fluzone at 15 mcg/dose. Novavax’s VLP vaccine was administered in two dosages of 15 mcg (83 candidates) and 60 mcg (81). It has been observed that the VLP vaccine induced a robust hemagglutination inhibition (HAI) antibody response against all the three strains.
Novavax is conducting another head to head trial of its VLP vaccine with Fluzone in adults above 60 years of age. Results of this trial are awaited.
The company also came out with positive results from the first stage of a two stage study evaluating the safety and effectiveness of its VLP vaccine against the H1N1 virus. This study is being conducted in collaboration with Avimex Laboratories of Mexico and GE Healthcare. If final results are encouraging enough, Novavax is looking at registering the vaccine in Mexico.
At the time of announcing fourth quarter results, Novavax said that it has identified a vaccine candidate for the prevention of respiratory syncytial virus [RSV]. The company plans to complete preparations for its Investigational New Drug [IND] filing for the vaccine in 2010.