* Vaccine found to be safe, induces immune responses
* Found to enhance performance of traditional flu vaccine
* Trial in elderly to begin in fourth quarter
TEL AVIV, June 16 (Reuters) - Israel’s BiondVax Pharmaceuticals said on Thursday it had positive results from the first Phase II clinical trial of its universal flu vaccine.
The Multimeric-001 vaccine was found to be safe and well tolerated and induced robust immune responses, successfully meeting both the primary safety and immunogenicity endpoints, as well as additional secondary endpoints.
It was also found that Multimeric-001, when used with a commercially available strain-dependant seasonal influenza vaccine, enhances the performance of the traditional vaccine.
“We have confirmed, in what is to our knowledge the first Phase II study of a universal influenza vaccine ever conducted in the world, that the Multimeric-001 vaccine is not only safe and immunogenic on its own, but it also has the potential to enhance the performance of traditional strain-dependant flu vaccines,” Ron Babecoff, BiondVax’s CEO, said.
The trial in 200 healthy volunteers was conducted at two clinical research centers in Israel.
The Multimeric-001 vaccine was safe and well tolerated and no vaccine-related severe adverse events were found in any of the participants.
The vaccine also induced both antibody and cell-mediated immune responses. Participants who received two doses of the Multimeric-001 vaccine showed a statistically significant increase in the level of IgG antibodies against the vaccine.
It was also found that the vaccine caused a statistically significant elevation in the secretion of Interferon-gamma, a known anti-viral agent, meeting one of the secondary endpoints.
The results of the trial “suggest that the Multimeric-001 has the potential, when administered in advance of future seasonal or pandemic influenza outbreaks, to raise the general level of preparedness of the population and thereby significantly improve the protection and broaden the cross-strain coverage offered by the strain-dependant influenza vaccines,” the company said.
BiondVax is preparing to conduct the next Phase II trial, in the elderly — the population group most at risk for influenza infections and for whom current vaccines are least effective.
It is expected that this trial will be conducted in two centers in Israel, in around 110 male and females aged 65 and over. This trial is expected to begin in the fourth quarter and to end in the first quarter of 2012. (Reporting by Tova Cohen; Editing by Erica Billingham)