US NIH trials flu vaccines from Sanofi and Novartis

The US National Institutes of Health has begun testing an H7N9 avian influenza vaccine candidate in humans. The two concurrent Phase II clinical trials, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, will gather information about the safety of the candidate vaccine and the immune system responses it induces when administered at different dosages and with or without adjuvants, substances designed to boost the body’s immune response to vaccination.

Sanofi and Novartis vaccines tested

The two clinical trials, which will enroll healthy adults aged 19 to 64, will evaluate an investigational H7N9 vaccine developed by French drug major Sanofi (Euronext: SAN). The candidate vaccine was made from inactivated H7N9 virus isolated in Shanghai, China in 2013. Adjuvants are being tested with the investigational vaccine because previous vaccine research involving other H7 influenza viruses has suggested that two doses of vaccine without adjuvant may not produce an immune response adequate to provide effective protection. In pandemic situations, adjuvants also can be used as part of a dose-sparing strategy, which would allow production of more doses of vaccine from the available supply of the viral antigen, thereby allowing a greater number of people to be vaccinated more quickly.