hVIVO preps phase 3 for ‘universal’ flu vaccine

A nurse preparing a medical injection
A more sensitive assay helped the vaccine hit its primary endpoint in a phase 2b trial. (Getty/scyther5)

U.K. biotech hVIVO is on course to start a phase 3 program for a flu vaccine that doesn’t need to have its composition tweaked every year—and as a result has been tipped by some analysts as a potential blockbuster.

hVIVO’s AIM-listed shares surged after the company revealed additional results for its phase 2b trial of FLU-v showing that it was able to significantly reduce mild to moderate influenza disease (MMID) compared to placebo, the study’s primary endpoint.

Last year, the National Institute of Allergy and Infectious Diseases (NIAID)—which is running the study—said that the vaccine had hit secondary targets including a reduction in flu symptoms, but there was a delay in getting the primary readout because patient samples needed further testing to confirm influenza infection.

A less sensitive assay was used initially which only showed a trend toward significance on the MMID outcome measure, so the NIAID retested samples using an improved assay that “identified more cases of influenza infection than had originally been determined, resulting in the achievement of statistical significance,” said hVIVO Executive Chairman Trevor Phillips, Ph.D., in a statement (PDF).

The trial represents the first time that a universal flu vaccine has been shown to reduce symptoms as well as stimulate an immunological response, according to Phillips.

In addition to sidestepping the need for the annual scramble to identify the prevailing influenza strains for inclusion in traditional flu vaccines, Flu-V is also designed to minimize the virus’ impact by reducing symptoms, potentially relegating it to a much milder disease.

The synthetic polypeptide vaccine is also less likely to result in a mismatch in flu strains, which can leave vulnerable patients at risk of infection even if they receive a shot. There is also hope that it could confer protection against emerging unexpected strains that can cause global epidemics, such as the H1N1 outbreak in 2009.

Moving Flu-V to phase 3 will be a big deal for hVIVO, which focuses mainly on providing viral challenge trial services to other pharma companies rather than developing its own products. It has set up a joint venture with fellow U.K. company SEEK Group—called Imutex—to develop the flu vaccine and has a 49% stake in that company.

Universal flu vaccine R&D programs are also being run by other groups, including Israel’s BiondVax Pharmaceuticals, which reported phase 3 results for its M-001 candidate at the World Vaccine Congress in San Diego last November.