Phase 1-2 Completed for Universal Influenza Vaccine

BiondVax Pharmaceuticals Ltd, an Israeli biopharmaceutical company, has completed Phase 1–2 clinical trials of its Multimeric-001 universal flu vaccine.

According to the test results, the Multimetric-001 universal flu vaccine, produced in E. coli, activates both the antibody and cellular arms of the human immune system. “This makes the BiondVax universal vaccine different from other universal vaccines, which only stimulate a humoral response,” said Tamar Ben-Yadidia, PhD, director of research and development at BiondVax. “It also contributes to the universality of the vaccine.”

BiondVax’s Multimeric-001 Universal Flu Vaccine also stimulated both humoral (antibody) and cellular responses against both influenza type A (including H1N1) and influenza type B. Other universal vaccines that are currently under development provide protection against influenza type A only.

The Phase 1–2 trial was a randomized, single-blind, placebo-controlled, escalating double-dose safety study in which a total of 60 participants, males and females aged 18–49, received two intramuscular injections containing the Multimeric-001 vaccine, either with or without the Montanide ISA 51 VG adjuvant, and at two different dose levels. The clinical trial results showed that BiondVax’s Multimeric-001 universal flu vaccine is safe to use at all doses tested, both with and without adjuvant.

This trial is the first of two Phase 1–2 clinical trials of the Multimeric-001 universal flu vaccine being conducted by BiondVax. The second trial has already commenced with 60 participants aged 55–75, and is expected to be completed in the first quarter of 2010.

BiondVax is one of several companies developing a universal vaccine. VaxInnate Dynavax, and Acambis (now part of Sanofi Aventis), all have universal vaccines in various stages of development.