A Phase II, Safety and Efficacy Study of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese 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 was completed, during four months, in Guangxi Province, China. The phase II clinical trial has been carried out, from July 2011. The purpose of phase II is to evaluate the safety and efficacy of the formalin-inactivated EV71 vaccine in Chinese infants (from 6 to 36 months old).

Conditions

• The Study Focused on the Safety of Inactivated EV71 Vaccine (Human Diploid Cell) Against Hand, Foot and Mouth Disease in Chinese Children and Infants

Interventions

BIOLOGICAL

160Eu/0.5ml in infants (6-11 months old)

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 60 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

320Eu/0.5ml in infants (6-11 months old)

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 60 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

640Eu/0.5ml in infants (6-11 months old)

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

1280Eu/0.5ml (without adjuvant) in infants (6-11 months old)

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 40 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

0Eu/0.5ml in infants (6-11 months old)

0Eu/0.5ml placebo in 80 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

160Eu/0.5ml in infants (12-23 months old)

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 30 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

320Eu/0.5ml in infants (12-23 months old)

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 30 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

640Eu/0.5ml in infants (12-23 months old)

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

1280Eu/0.5ml (without adjuvant) in infants (12-23 months old)

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 40 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

0Eu/0.5ml in infants (12-23 months old)

0Eu/0.5ml placebo in 50 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

160Eu/0.5ml in children (24 months-5 years old)

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 30 children aged 24 months-5 years months old on day 0, 28

BIOLOGICAL

320Eu/0.5ml in children (24 months-5 years old)

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 30 children aged 24 months-5 years months old on day 0, 28

BIOLOGICAL

640Eu/0.5ml in children (24 months-5 years old)

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 children aged 24 months-5 years months old on day 0, 28

BIOLOGICAL

1280Eu/0.5ml (without adjuvant) in children (24 months-5 years old)

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml in 40 children aged 24 months-5 years months old on day 0, 28

BIOLOGICAL

0Eu/0.5ml in children (24 months-5 years old)

0Eu/0.5ml placebo in 50 children aged 24 months-5 years 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

5 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2012-01-31

Completion

2012-02-29

Countries

• China

Study Locations