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 trial has been carried out, during four months, in Guangxi Province, China. The purpose of this study is to evaluate the safety, tolerability and immunogenicity of the formalin-inactivated EV71 vaccine in Chinese adults (from 18 to 49 years old), children (from 3 to 11 years old) and infants (from 6 to 35 months old).
Age range
6 Months – 49 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.
Timeframe: within the first 14 days after the first vaccination
Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.
Timeframe: within the first 4 days after the second vaccination
Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
Timeframe: within the first 14 days after the first vaccination
Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
Timeframe: within the first 4 days after the second vaccination
Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.
Timeframe: within the first 28 days after the first vaccination
Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.
Timeframe: within the first 28 days after the second vaccination