Avian Influenza Clinical Trial
Official title:
A Phase 2/3 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
The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested.
Although the A/H1N1 (2009) pandemic has subsided and the virus has become endemic, the threat
of another pandemic due to avian influenza A/H5N1 remains constant. 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, WHO
has reported 826 confirmed human cases of A/H5N1 influenza infection; including 440 fatal
cases (World Health Organization, 2015). 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 (World Health Organization, 2015). As of
March 2015, Vietnam has reported 127 confirmed human cases and 64 deaths. In 2014, two cases
of A/H5N1 avian influenza were reported in Vietnam. Therefore, the risk of transmission to
human is still present.
At the time of the study, no influenza A/H5N1 vaccine had been licensed in Vietnam.
IVACFLU-A/H5N1 is an influenza A/H5N1 vaccine produced by Institute of Vaccines and Medical
Biologicals (IVAC) using embryonated chicken eggs. IVACFLU-A/H5N1 is a whole virus vaccine,
collected in a linear sucrose density gradient solution using a continuous flow centrifuge
(Alfa Wassermann, West Caldwell, NJ) and inactivated with formaldehyde. The vaccine is alum
adjuvanted. Vaccine strain NIBRG-14 derived from original influenza A/Vietnam/1194/2004 was
provided to IVAC by the National Institute for Biological Standards and Control of the Health
Protection Agency of the United Kingdom. A clinical trial of IVACFLU-A/H5N1 vaccine conducted
in 75 subjects at the Ben Luc Health District in Vietnam in 2014 showed that the vaccine is
safe and immunogenic at doses of 7.5 and 15 mcg.
This study was conducted in two stages: Phase 2 was a dose selection study where subjects
were randomized to one of the three groups (15 mcg IVACFLU-A/H5N1 vaccine, 30 mcg
IVACFLU-A/H5N1 vaccine or placebo) at a 1:1:1 ratio. The conduct of Phase 3 was dependent on
showing hemagglutination inhibition (HAI) response titer of ≥1:40 in ≥60% of vaccine
recipients in at least one of the two Phase 2 IVACFLU-A/H5N1 vaccine groups. Based on the
review of immunogenicity and safety results from the Phase 2 study, a dose of study vaccine
was selected for Phase 3. Subjects were randomized at two sites (Khanh Hoa and Hai Phong) to
receive the IVACFLU-A/H5N1 vaccine dose selected in Phase 2 or placebo . Safety was assessed
in all subjects and immunogenicity was measured in a subset of subjects at the Hai Phong
study site.
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