One year ago, a new technology predicted that significant outbreaks of the H1N1 flu virus would occur within 6 to 12 months. One year later, the H1N1 flu virus triggered a stage 5 pandemic alert from the World Health Organization.
While the ability to accurately predict influenza outbreaks and their locations is extraordinary, the same technology can be used to develop flu vaccines.
The predictions, made by Replikins, were based on correlations of flu virus specimen and Pub Med documentation of major outbreaks during the past 90 years, focusing on concentrations of, and spacings between, replikins—the lysine and histidine residues in the hemagglutinin unit genetic sequences of the eight major genes in the influenza virus.
Sam Bogoch, M.D., Ph.D., chairman of Replikins, says those replikins are strain-specific and determine the virus’ rate of replication. High counts (e.g., seven replikins per 100 amino acids) indicate an outbreak is imminent. Lower counts (four per 100 amino acids) indicate the virus will remain dormant indefinitely. The analysis showed a point-for-point correlation between high replikin counts and outbreaks.
Dr. Bogoch notes that the company’s PanFlu™, a vaccine that interferes with replikins, is ready for clinical trials. A similar vaccine has proved effective in blocking H5N1 transmission among chickens, and has conferred 91% protection against the lethal Taura syndrome in shrimp populations, he points out, adding that because the replikins are conserved, this strategy has the potential to become a broad-spectrum flu vaccine. That vaccine can be manufactured in seven days, he explains.
Novavax plans to create a virus-like particle-based (VLP) vaccine against the H1N1 strain, according to Rahul Singhvi, Sc.D., president and CEO. “Our recombinant VLP technology obviates the need for a live virus seed for manufacturing,” he says. Therefore, “We can cut the cycle time from strain identification to production of the first vaccine to just 10 to 12 weeks.”
The VLPs contain the proteins that make the virus’ outer shell and the surface proteins, without the RNA required for replication. “There’s no genetic material in these VLPs, and they are unable to replicate,” Dr. Singhvi emphasizes.
The vaccine includes three immunologically important proteins (hemagglutinin, neuraminidase, and matrix1) and is matched to the wild-type virus that causes influenza in humans.