VaxInnate begins H5N1 avian flu Phase I clinical trial

VaxInnate, a Cranbury, New Jersey-based biotechnology company, announced on Tuesday that enrollment has commenced for its phase I clinical trial to evaluate an H5N1 vaccine candidate for pandemic avian flu.

The clinical trial to evaluate VAX161, a novel H5 vaccine candidate for preventing bird flu, is being conducted under the company's contract with the Biomedical Advanced Research and Development Authority. The study will evaluate the immunogenicity and safety of two doses of VAX161 given by intramuscular injection three weeks apart at six dose levels. Results from the study are anticipated later this year.

"The objective of this study is to optimize the dose, based on the immunogenicity and safety of VAX161," David Taylor, the chief medical officer of VaxInnate, said. "We believe our vaccine candidate has the potential to be a highly effective and much-needed vaccine for pandemic avian flu."

VAX161 is a recombinant fusion protein prototype that could become a single-component, two-dose vaccine against pandemic avian flu. While H5N1 is typically an influenza virus in birds, there have been 584 humans infected since 1987, leading to 345 deaths in 15 countries. Person-to-person transmission has been limited, but scientists are concerned that mutation or genetic recombination could eventually result in a human pandemic.

"We believe VaxInnate's approach to vaccine development holds a great deal of promise for avian flu and look forward to learning more about the potential of VAX161 in this clinical trial," Casey Johnson, the principal investigator of Johnson County Clin-Trial in Lenexa, Kan., said.