VaxInnate begins phase II trial of quadrivalent seasonal influenza vaccine candidate

Biotechnology firm VaxInnate has started an active comparator controlled phase II trial to evaluate the safety and immunogenicity of its VAX2012Q quadrivalent seasonal influenza vaccine candidate, in the US.

Fluzone Quadrivalent, a commercially available vaccine, is the active comparator in the VAX2012Q clinical trial.

Around 450 healthy adults, aged 18-64, will be enrolled for the trial.

They will receive, in a blinded fashion, a single dose of vaccine, either VAX2012Q at 2mcg or 3mcg per component or the standard 15mcg per component dose of Fluzone Quadrivalent.

The trial is also designed to measure immune response to each of the four components of VAX2012Q.

VaxInnate president and CEO Wayne Pisano said: "We believe our proprietary recombinant vaccine production technology offers significant benefits over traditional manufacturing methods, including reliability and cost effectiveness.

"In addition, our technology also has the important benefit of speed, which can be essential when reacting to unexpected strain drifts, as we witnessed earlier in 2015.

"The initiation of this phase II study represents another important milestone on our path to commercialization, and we look forward to seeing top-line results later this year."

Under the trial, the company will monitor immunogenicity and safety after 21 and 90 days, and patients will be followed for one year after their vaccination to evaluate long-term safety.

Patient enrollment in the trial is expected to be completed by mid-2015 and preliminary results will be reported in the second half.

The company recently concluded a phase I trial of VAX2012Q in healthy adults 18-40 years of age. The trial showed that doses as low as 2mcg per component elicited robust immune responses to each of the four vaccine components.

The phase II trial is being fully funded by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS).

Image: VaxInnate's quadrivalent seasonal influenza vaccine candidate VAX2012Q will be evaluated in about 450 healthy. Photo: courtesy of Baitong333 / Freedigitalphotos.net.