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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hand, Foot and Mouth Disease

Intervention / Treatment
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* Biological: vaccine against EV71 of 320U/0.5ml
* Biological: vaccine against EV71 of 640U/0.5ml
* Biological: vaccine against EV71 of 160U/0.5ml
* Biological: vaccine against EV71 of 320U/0.5ml
* Biological: vaccine against EV71 of 640U/0.5ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 320U /0.5ml in young adults<br>inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 20 young adults aged 16-22 years old on day0,28 | Biological: vaccine against EV71 of 320U/0.5ml<br>* inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28,modern medicines<br>|
| Experimental: 640U /0.5ml in young adults<br>inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 20 young adults aged 16-22 years old on day0,28 | Biological: vaccine against EV71 of 640U/0.5ml<br>* inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28<br>|
| Experimental: 160U /0.5ml in children<br>inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 20 children aged 5-15 years old on day0,28 | Biological: vaccine against EV71 of 160U/0.5ml<br>* inactivated vaccine(vero cell) against EV71 of 160U/0.5ml on 0,28 day<br>|
| Experimental: 320U /0.5ml in children<br>inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 20 children aged 6-15 years old on day0,28 | Biological: vaccine against EV71 of 320U/0.5ml<br>* inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28<br>|
| Experimental: 640U /0.5ml in children<br>inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 20 children aged 6-15 years old on day0,28 | Biological: vaccine against EV71 of 640U/0.5ml<br>* inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the seroconversion rate of Antinuclear antibodies in serum after first vaccination | to evaluate the seroconversion rate of Antinuclear antibodies in serum 28 days after first vaccination | 28 days after the first vaccination | 
| to evaluate the seroconversion rate of Antinuclear antibodies in serum after second vaccination | to evaluate the seroconversion rate of Antinuclear antibodies in serum 28 days after second vaccination | 28 days after second vaccination | 
| to evaluate the abnormity change of live and kidney function indexes in serum after first vaccination | to evaluate the abnormity change of live and kidney function indexes in serum 3 days after first vaccination | 3 days after first vaccination | 
| to evaluate the abnormity change of live and kidney function indexes in serum after second vaccination | to evaluate the abnormity change of live and kidney function indexes in serum 3 days after second vaccination | 3 days after second vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccines Adverse Reaction