A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children

Summary

Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community.

The development of vaccine against EV71 is active and ongoing in Asian countries now. Several studies have examined the effectiveness of inactivated viral vaccines against EV71 in animal model. A wide range of experimental EV71 vaccine approaches have been studied including heat-inactivated or formaldehyde-inactivated virion, EV71 virus-like particles (VLP) , VP1 recombinant protein ,VP1 DNA vaccine , VP1 peptide-based vaccine targeting the neutralizing domain, bacterial or viral vector expressing VP1, and a Vero cell-adapted live attenuated virus. Furthermore, neutralizing antibodies against EV71 have been suggested as one of the most important factors in prevention of the severe EV71 infection. Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase Ia is armed to evaluate safety and tolerance in Chinese healthy adults and children.

Conditions

• Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

vaccine against EV71 of 320U/0.5ml

inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28,modern medicines

BIOLOGICAL

vaccine against EV71 of 640U/0.5ml

inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28

BIOLOGICAL

vaccine against EV71 of 160U/0.5ml

inactivated vaccine(vero cell) against EV71 of 160U/0.5ml on 0,28 day

BIOLOGICAL

vaccine against EV71 of 320U/0.5ml

inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28

BIOLOGICAL

vaccine against EV71 of 640U/0.5ml

inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28

Sponsors & Collaborators

• Bejing Vigoo Biological Co., LTD

  collaborator INDUSTRY

• Jiangsu Province Centers for Disease Control and Prevention

  lead NETWORK

Principal Investigators

• Fengcai Zhu, Master · Jiangsu Provincial Center for Diseases Control and Prevention

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2011-05-31

Completion

2011-06-30