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

Authors: Guan Mu Dong, Liang Han, An Qi, Wen Xue Liu, Yan Kong, Lihong H. Yang

Addresses: First Division of Viral Vaccine, The National Institute for the Control of Pharmaceutical and Biological Products, Tian Tan Xili #2, Beijing 100050, PR China. ' Changchun Institute of Biological Products, 158 Xian Main Road, Changchun 130062, PR China. ' First Division of Viral Vaccine, The National Institute for the Control of Pharmaceutical and Biological Products, Tian Tan Xili #2, Beijing 100050, PR China. ' First Division of Viral Vaccine, The National Institute for the Control of Pharmaceutical and Biological Products, Tian Tan Xili #2, Beijing 100050, PR China. ' First Division of Viral Vaccine, The National Institute for the Control of Pharmaceutical and Biological Products, Tian Tan Xili #2, Beijing 100050, PR China. ' First Division of Viral Vaccine, The National Institute for the Control of Pharmaceutical and Biological Products, Tian Tan Xili #2, Beijing 100050, PR China

Abstract: 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 titers 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.

Keywords: haemorrhagic fever with renal syndrome; HFRS; inactivated bivalent vaccine; cell culture based vaccine; immunogenicity; human clinical trials; safety; tolerance; China; neutralising antibody titers; protective immunity.

DOI: 10.1504/IJBT.2007.014246

International Journal of Biotechnology, 2007 Vol.9 No.3/4, pp.261 - 266

Available online: 27 Jun 2007 *

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