Safety and immunogenicity of bivalent inactivated vaccine against haemorrhagic fever with renal syndrome in a phase II trial on healthy Chinese volunteers

摘要

We have developed a cell culture-derived, inactivated bivalent vaccine against both Haemorrhagic Fever with Renal Syndrome (HFRS) viruses 84 Fli (type I) and L99 (type II). This purified vaccine was tested in the clinical phase I/II trial in healthy non-infected adults in China. About 518 volunteers in Southern region and 650 volunteers from the Northern region of China were vaccinated. Volunteers then received one or two boosts at two weeks post-vaccination. No obvious side effects were observed among vaccinees after each inoculation. More than 87% of vaccinees have exhibited high neutralising antibody liters by Plaque Reducing Neutralising Test (PRNT) against both types I and II viruses and 100% positive seroconversion of IgG antibody by ELISA. These results indicate that our purified cell culture-derived bivalent vaccine is safe, well-tolerated and capable of inducing a protective immunity.