Influenza A/H5N1 clinical trials

Safety and Immunogenicity of IVACFLU-A/H5N1 in Vietnamese Adult

Influenza is one of the major infectious disease threats to the human population due to both the adverse health impact of annual influenza epidemics and the detrimental global consequences of influenza pandemics. Since 1997, highly pathogenic A/H5N1 avian viruses have caused both widespread outbreaks in poultry with high mortality and sporadic, severe, and fatal disease in humans. Southeast Asian countries, including Vietnam, have been affected by influenza A/H5N1. From 2003 through March 2015, 826 confirmed human cases of A/H5N1 influenza infection have been reported by the World Health Organization; including 440 fatal cases. Southeast Asian countries accounted for 42% of all confirmed influenza A/H5N1 cases reported since 2003, and influenza A/H5N1 infection in animals is now thought to be endemic in the region. As of March 2015, Vietnam has reported 127 confirmed human cases and 64 deaths. In 2014, 2 cases of A/H5N1 avian influenza were reported in Vietnam. Therefore, the risk of transmission to human is still present. Currently, no influenza A/H5N1 vaccine has been licensed in Vietnam. If a pandemic emerged, vaccine demand could be huge. This is a Phase 2, double-blind, randomized, placebo-controlled trial to test the safety and immunogenicity of two doses given 21 days apart of the IVAC A/H5N1 vaccine.