BiondVax plans Phase 2 test of pandemic primer vaccine
M-001 is the universal flu vaccine candidate for a primer vaccine from BiondVax. As a primer vaccine, it would be administered weeks before the administration of a pandemic vaccine.
"The recognition of the potential of our technology by a foremost public health authority in the United States, is a significant milestone in our clinical development program,” BiondVax's President and CEO Ron Babecoff said. “This trial will assess our vaccine's ability to be used as the stockpiled flu vaccine for pandemic protection. The scenario is that immediately following a flu pandemic outbreak of any strain, our vaccine could be used from Day Zero, saving multiple lives and limiting the wild spread of a flu pandemic. This collaboration with NIAID brings us a significant step closer to our Phase 3 clinical trial."
The U.S. trial, which is part of a partnership between the NIAID and BiondVax, is scheduled for this year and next.
"This important trial is examining the use of M-001 in the event of an H7 avian influenza outbreak,” BiondVax's Chief Scientific Officer Tamar Ben-Yedidia said. “It is complementary to a previous clinical trial in the elderly that concluded successfully, showing enhanced immunogenicity against the H1N1 swine pandemic virus in participants that received our M-001 vaccine as primer. This study is also complementary to our upcoming European clinical trial in which the M-001 will serve as a primer to the H5N1 avian pandemic vaccine."