A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
A Phase Ia Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
1 other identifier
interventional
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2011
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2010
CompletedFirst Posted
Study publicly available on registry
December 29, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 10, 2011
January 1, 2011
4 months
December 28, 2010
June 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
to evaluate the safety of EV71 vaccine in Chinese healthy adults and children
to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children
28 days after the first vaccination
to evaluate the safety of EV71 vaccine in Chinese healthy adults and children
to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children
28 days after the second vaccination
Secondary Outcomes (4)
to evaluate the seroconversion rate of Antinuclear antibodies in serum after first vaccination
28 days after the first vaccination
to evaluate the seroconversion rate of Antinuclear antibodies in serum after second vaccination
28 days after second vaccination
to evaluate the abnormity change of live and kidney function indexes in serum after first vaccination
3 days after first vaccination
to evaluate the abnormity change of live and kidney function indexes in serum after second vaccination
3 days after second vaccination
Study Arms (5)
320U /0.5ml in young adults
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 20 young adults aged 16-22 years old on day0,28
640U /0.5ml in young adults
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 20 young adults aged 16-22 years old on day0,28
160U /0.5ml in children
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 20 children aged 5-15 years old on day0,28
320U /0.5ml in children
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 20 children aged 6-15 years old on day0,28
640U /0.5ml in children
EXPERIMENTALinactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 20 children aged 6-15 years old on day0,28
Interventions
inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28,modern medicines
inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28
inactivated vaccine(vero cell) against EV71 of 160U/0.5ml on 0,28 day
Eligibility Criteria
You may qualify if:
- Healthy subjects aged from 5 to 22 years old as established by medical history and clinical examination
- The subjects or their guardians are able to understand and sign the informed consent
- Had never received the vaccine against EV71
- Subjects who can and will comply with the requirements of the protocol
You may not qualify if:
- Subject that has a medical history of HFMD
- subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Family history of congenital or hereditary immunodeficiency
- Women of pregnancy, lactation or about to be pregnant in 60 days
- Autoimmune disease or immunodeficiency
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- Any prior administration of administration of immunoglobulins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Meng FY, Li JX, Li XL, Chu K, Zhang YT, Ji H, Li L, Liang ZL, Zhu FC. Tolerability and immunogenicity of an inactivated enterovirus 71 vaccine in Chinese healthy adults and children: an open label, phase 1 clinical trial. Hum Vaccin Immunother. 2012 May;8(5):668-74. doi: 10.4161/hv.19521. Epub 2012 May 1.
PMID: 22634437DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengcai Zhu, Master
Jiangsu Provincial Center for Diseases Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
December 28, 2010
First Posted
December 29, 2010
Study Start
January 1, 2011
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
June 10, 2011
Record last verified: 2011-01