Influenza A/H5N1 Clinical Trial
Official title:
A Phase 2 Double Blinded, Randomized, Placebo-controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC
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.
In the Phase 2 study, 300 healthy adult subjects will be randomised to 3 groups (100 subjects/group), receiving 2 doses of vaccine (either 15ug/dose or 30ug/dose) or 2 doses of saline placebo. Safety and immunogenicity after each dose of vaccine will be assessed in all 300 subjects. Although full evaluation of the safety will continue through Day 91, there will be an early evaluation of the safety and immunogenicity data collected through Day 43 of Phase 2 to determine whether to proceed to Phase 3 and which vaccine dose to select. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention