A Protected Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and Children

Summary

Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in the Asia-Pacific region. Notably, there is evidence that the most severe cases from these epidemic outbreaks are associated with neurological disorders with CNS involvement caused by EV71 infection. Because of these EV71 infection-related public health issues, the research and development of EV71 vaccine candidates have been heavily promoted. Recently, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, including inactivated vaccine, attenuated vaccine, subunit vaccine, DNA vaccine, epitope peptide vaccine, virus-like particles (VLPs). Basing on the previous studies of elicited protection in mice and rhesus monkeys, a formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by SFDA in China, Dec. 2010. The phase I clinical and phase II trials were completed, in Guangxi Province, China. The results of these clinical trials showed that this vaccine was safe and could induce effective antibodies for the infants. The purpose of phase III is to evaluate the protected and efficacy of the formalin-inactivated EV71 vaccine in Chinese infants and children (from 6 to 71 months old).

Timeline

Start

2012-03

Primary completion

2013-03

Completion

2013-03

Outcome

Met primary endpoint

paper Over the course of two epidemic seasons, the vaccine efficacy was 97.4% (95% confidence interval [CI], 92.9 to 99.0) according to the intention-to-treat analysis PMID 24571755 ↗

Publications

• Zhang W, Kong Y, Jiang Z, Li C, Wang L, Xia J. Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial. Hum Vaccin Immunother. 2016 Apr 2;12(4):922-30. doi: 10.1080/21645515.2015.1115934. Epub 2016 Feb 2.
• Liu L, Mo Z, Liang Z, Zhang Y, Li R, Ong KC, Wong KT, Yang E, Che Y, Wang J, Dong C, Feng M, Pu J, Wang L, Liao Y, Jiang L, Tan SH, David P, Huang T, Zhou Z, Wang X, Xia J, Guo L, Wang L, Xie Z, Cui W, Mao Q, Liang Y, Zhao H, Na R, Cui P, Shi H, Wang J, Li Q. Immunity and clinical efficacy of an inactivated enterovirus 71 vaccine in healthy Chinese children: a report of further observations. BMC Med. 2015 Sep 17;13:226. doi: 10.1186/s12916-015-0448-7.
• Li R, Liu L, Mo Z, Wang X, Xia J, Liang Z, Zhang Y, Li Y, Mao Q, Wang J, Jiang L, Dong C, Che Y, Huang T, Jiang Z, Xie Z, Wang L, Liao Y, Liang Y, Nong Y, Liu J, Zhao H, Na R, Guo L, Pu J, Yang E, Sun L, Cui P, Shi H, Wang J, Li Q. An inactivated enterovirus 71 vaccine in healthy children. N Engl J Med. 2014 Feb 27;370(9):829-37. doi: 10.1056/NEJMoa1303224.

Drugs

Indications

No indication recorded.