Biotechnology firm VaxInnate has commenced a Phase II study to assess the safety and immunogenicity of its quadrivalent seasonal influenza vaccine candidate, VAX2012Q.
Fluzone Quadrivalent, which is a commercially available vaccine, is the active comparator in the study.
The double-blind, randomised and active comparator controlled trial is being funded by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), and the Department of Health and Human Services (HHS) in the US.
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."
The company will enrol around 450 healthy adults, aged between 18 to 64 years for the trial, at six locations in the US.
The participants in the study will receive a single dose of vaccine blind, either VAX2012Q at 2mcg or 3mcg per component, or the standard 15mcg per component dose of Fluzone Quadrivalent.
According to the firm, the trial will evaluate immune responses to each of the four components of VAX2012Q.
In the study, the company will monitor immunogenicity and safety after 21 and 90 days, and participants will be followed for one year after their vaccination to evaluate long-term safety.
Patient enrolment in the trial is expected to be complete by the middle of this year, and preliminary results will be revealed in the second half of this year.
VaxInnate has already completed Phase I trials of VAX2012Q in healthy adults of 18 to 40 years of age, in which doses as low as 2mcg per component elicited better immune responses to each of the four vaccine components.
