Date: 2012-02-16
Type of information: Initiation of preclinical development
phase: 2
Announcement: results
Company: BiondVax Pharmaceuticals (Israel)
Product: multimeric-001 vaccine (M-001)
Action
mechanism: Multimeric-001 is an universal influenza vaccine
Disease: influenza
Therapeutic area: Infectious diseases
Country: Israel
Trial
details: This Phase II trial was a randomized, double-blind, placebo-controlled study in 120 elderly (65+) volunteers conducted at two clinical research centers in Israel – the Hadassah University Hospital in Jerusalem and the Tel Aviv Sourasky Medical Center.
Latest
news: BiondVax Pharmaceuticals has announced positive results from its second Phase II clinical trial (BVX-005) of the Universal Influenza Vaccine (Multimeric-001) developed by Biondvax for improving existing flu vaccines in elderly. The vaccine was found to be safe and well tolerated, and induced robust cellular and humoral immune responses in elderly patients (65+), successfully meeting the primary safety and secondary immunogenicity endpoints. In addition, when given as a primer before boosting with a commercially available seasonal influenza vaccine (trivalent inactivated vaccine, or TIV), Multimeric-001 vaccine enhanced the performance of the TIV by increasing immunity to influenza strains contained in the TIV (“prime-boost” regimen).
The Multimeric-001 vaccine improved immunity to influenza in the elderly without the need for any adjuvant. The effectiveness of priming with Multimeric-001 was determined by means of hemagglutination inhibition (HAI) assays. HAI-based immune measures are utilized by US and European regulatory authorities to approve and license existing influenza vaccines.
In light of the successful conclusion of this second Phase II clinical trial in the elderly in Israel, BiondVax is preparing to conduct a third Phase II trial in the elderly in Europe. This trial is expected to commence in the third quarter of 2012 and to be concluded in the first quarter of 2013.
Dr. Ben-Yedidia will report the results of this second Phase II clinical trial in April 2012 at the 2nd Annual Vaccines Congress in London, UK and at the World Vaccine Congress in Washington DC, USA, in a presentation entitled “Multimeric-001: Improving flu vaccines for elderly - new insights from a Phase II clinical trial”.
