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).

Conditions

• The Efficacy of Inactivated EV71 Vaccine (KMB17) Against HFMD in Chinese Children and Infants

Interventions

BIOLOGICAL

100U/0.5ml in 6-11 months old infants

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

100U/0.5ml in 12-23 months old infants

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

100U/0.5ml in 24-35 months old children

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1500 children aged 24-35 months old on day 0, 28

BIOLOGICAL

100U/0.5ml in 36-71 months old children

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1000 children aged 36-71 months old on day 0, 28

Sponsors & Collaborators

• Guangxi Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Institute of Medical Biology, Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Zhaojun Mo, Master · Guangxi Provincial Center for Diseases Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

71 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2013-03-31

Completion

2013-03-31

Countries

• China

Study Locations