BiondVax Pharmaceuticals Ltd. has announced it received the statistical analysis of results from a study which demonstrates that BiondVax's universal flu vaccine (M-001), administered in the BVX-005 phase II trial which took place in 2012, provided participants with increased immunogenicity against future strains which did not exist at the time of the study- in particular the current newly emerged H3N2 influenza (flu) strain that caused the epidemic in the United States in 2015.
In 2012, 120 elderly participants aged 65 or over, participated in the BVX-005 trial. This trial was concluded successfully, demonstrating induction of both humoral and cellular immune responses to BiondVax's vaccine and to multiple influenza viruses. In that trial, 90 participants were injected with the M-001 universal flu vaccine a few weeks prior to immunization with TIV (the commercially available seasonal flu vaccine of that time). The remaining group of 30 was a control group which was provided with a placebo followed by the TIV.
Three years later, in 2015, BiondVax exposed the blood plasma samples from the BVX-005 participants (taken following the completion of the trial in 2012) to the current influenza flu epidemic H3N2 strain (A/Switzerland/9715293/2013), which in 2012 did not yet exist.
BiondVax examined the immunogenicity (HAI) antibodies in each blood plasma sample and found significantly increased level of protective antibodies against the H3N2 strain in the samples taken from participants that received the M-001 vaccine in comparison to the control group. An average of 50% or greater of the participants in the experimental group receiving M-001 showed immunogenicity against this new strain versus only 10% on average in the control group, a result which has statistically high significance.
This concurs with the similar results found in BiondVax's recent BVX-006 phase II trial, showing increased antibody response to the H3N2 epidemic flu strain in those that received BiondVax's universal vaccine, although it was not included in the commercially available seasonal flu vaccine of the 2014/15 season. Management believe that this data confirms the universal nature of BiondVax's vaccine, protecting against all types of flu strains.
Ron Babecoff, BiondVax's President and CEO, commented, "We are happy that the participants which received our vaccine in the trial three years ago present a higher immunogenicity, even to actual flu strains in circulation now. The independently provided statistical analysis we reported today is very important as it demonstrates that M-001 provides a safety net by broadening the immunogenicity to existing and future flu strains - in this case, against a specific flu strain that back when the trial was conducted, did not yet exist. If our vaccine was approved by the necessary regulatory bodies and available in the market during the last winter, we believe that the recent epidemic could have been prevented. These results are another important data point showing the importance of our work for global public health and in particular for the elderly which are most vulnerable to this dangerous virus."