[Safety and immunogenicity of inactivated bivalent EHF vaccine in humans]

Safety and immunogenicity of inactivated bivalent EHF vaccine in humans were evaluated in the epidemic area of Zhejiang province, China.

Susceptible persons with negative anti-EHF were selected in Jiande county, Zhejiang province to receive 3 doses of inactivated bivalent EHF vaccine at 0, 7, 28 days. A booster injection was given one year after the primary immunization. Antibody responses were measured in human volunteers by IFA and MCPENT. Local and general reactions were recorded within 72 hours after each vaccination by physicians.

Two weeks after the primary vaccination, 99.04% of the subjects developed significant hantavirus antibody titre measured by IFA which had a 37.34% drop one year after the primary vaccination. Seroconversion rate increased to 100% two weeks after the booster dose. Neutralising antibody titres paralleled this trend with 100% of vaccine recipients producing neutralising antibody two weeks after the primary doses. However, it dropped to 80% one year after the primary vaccination. One hundred percent of the vaccine recipients started to respond two weeks after boosting. The geometric mean titre (GMT) of neutralising antibody against 76 - 118 and UR were 18.27 +/- 2.21 and 12.47 +/- 2.16 respectively after the primary injections, but it increased to 37.09 +/- 2.24 and 32.61 +/- 2.05 respectively after the secondary immunization. General and local reaction rates were 0.46% and 1.98%, with no severe side effects observed in the vaccinees.

The vaccine was well tolerated and could induce good humoral immune response.