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

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 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).

Conditions

• Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

160Eu/0.5ml in adults

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.

BIOLOGICAL

320Eu/0.5ml in adults

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.

BIOLOGICAL

640Eu/0.5ml in adults

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.

BIOLOGICAL

1280Eu/0.5ml (without adjuvant) in 12 adults

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 adults aged 18-49 years old on day 0, 14.

BIOLOGICAL

0Eu/0.5ml in adults

0Eu/0.5ml placebo in 24 adults aged 18-49 years old on day 0, 14.

BIOLOGICAL

160Eu/0.5ml in children

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.

BIOLOGICAL

320Eu/0.5ml in children

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.

BIOLOGICAL

640Eu/0.5ml in children

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.

BIOLOGICAL

1280Eu/0.5ml (without adjuvant) in children

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 children aged 3-11 years old on day 0, 14.

BIOLOGICAL

0Eu/0.5ml in children

0Eu/0.5ml placebo in 24 children aged 3-11 years old on day 0, 14.

BIOLOGICAL

160Eu/0.5ml in infants

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.

BIOLOGICAL

320Eu/0.5ml in infants

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.

BIOLOGICAL

640Eu/0.5ml in infants

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.

BIOLOGICAL

1280Eu/0.5ml (without adjuvant) in infants

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 24 infants aged 6-35 months old on day 0, 28.

BIOLOGICAL

0Eu/0.5ml in infants

0Eu/0.5ml placebo in 48 infants aged 6-35 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

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2011-06-30

Completion

2011-06-30

Countries

• China

Study Locations