BiondVax Reports Positive Phase 2b Clinical Trial Results for Universal Flu Vaccine

BiondVax Pharmaceuticals and the UNISEC consortium reported statistically significant positive results from the Phase 2b clinical trial of M-001, BiondVax's universal flu vaccine candidate.

The study had two primary endpoints: Safety and influenza-specific cellular immune responses. Both endpoints were achieved.

The randomized placebo-controlled double-blind trial consisted of 3 arms; The 219 participants, aged 18 to 60 years, twice received either 0.5mg M-001, 1.0mg M-001, or saline placebo. All participants were then immunized with a partial dose of avian H5N1 pandemic vaccine.

The company previously reported and today confirms that M-001 has a good safety profile and is well-tolerated.

TH1 cytokines including Il-2, Interferon-gamma, and TNF-alpha are biological molecules with known anti-viral and anti-influenza virus activity. These cytokines are produced by CD4 immune system cells when activated as part of T-cell dependent immunity. In this trial, T-cell (also known as cellular) immunity was measured at baseline (prior to immunization), and after immunization with M-001. Compared to the placebo group, statistically significant elevated T-cell dependent immune responses were found in both dosage forms, more notably in the 1.0mg dose group.

The study's secondary endpoint evaluated antibody (HAI) response to avian H5N1 pandemic vaccination after M-001 or placebo administration. In one of the four H5N1 strains tested, a statistically significant HAI elevation was observed in participants who had received M-001.