GlaxoSmithKline has announced that its H5N1 vaccine achieved a high immune response in a clinical trial in Belgium.
Investigators immunized 400 healthy adults with a vaccine that contained an inactivated H5N1 virus and a proprietary adjuvant. Subjects were vaccinated twice.
The lowest strength tested was 3.8 mcg of antigen, along with three higher doses. At 3.8 mcg, 80% of the patients demonstrated a seroprotective response.
The vaccine has not received marketing approval from any regulatory agency, although Jean-Pierre Garnier, GSK's chief executive officer, said the company will apply for approval in the coming months.
“This is the first time such a low dose of H5N1 antigen has been able to stimulate this level of strong immune response,” Mr. Garnier said. “There is still a lot more work to be done with this program, but this validation of our approach provides us with the confidence to continue developing the vaccine, including assessment of its ability to offer cross-protection to variants of the H5N1 strain.”