Systems Biology of Vaccination for EV71 Vaccine in Humans
Study Details
Study Description
Brief Summary
Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1 and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the candidate vaccine for the phase 3 clinical trial.
This clinical trial is a supplementary phase 2 trial, which is designed to study the gene expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5 years old use a systems biology approach combined with microarray analysis，RT-PCR and neutralizing antibody testing for PBMC and serum collected form the studied children population, to predict immunogenicity, and explore mechanistic insights about the EV71 vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 320U /0.5ml in children (from 2 to 5 years old) inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 48 children aged 2-5 years old on day 0,28 |
Biological: 320U /0.5ml
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 4 weeks interval
|
| Placebo Comparator: 0/0.5ml placebo in children (from 2 to 5 years old) 0/0.5ml placebo in 24 children aged 2-5 years old on day 0, 28 |
Biological: 0/0.5ml placebo
0/0.5ml placebo, two doses, 4 weeks interval
|
Outcome Measures
Primary Outcome Measures
- Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine [Frame: 3 days after first dose]
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 3 in children aged 2-5 years
- Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine [7 days after first dose]
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 7 in children aged 2-5 years
- Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine [28 days after first dose]
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 28 in children aged 2-5 years
- Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine [28 days after second dose]
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 56 in children aged 2-5 years
- Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine [6 months after first dose]
Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at month 6 in children aged 2-5 years
Secondary Outcome Measures
- GMT, seroconversion rate of anti-EV71 antibodies in serum after first vaccination [28 days after the first vaccination]
GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination
- GMT, seroconversion rate of anti-EV71 antibodies in serum after second vaccination [28 days after second vaccination]
GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination
- the safety of EV71 vaccine in healthy children aged 2-5 years [28 days after the first dose]
Frequency of systemic and local adverse reactions within 28 days after the first dose of EV71 vaccine in healthy children aged 2-5 years
- the safety of EV71 vaccine in healthy children aged 2-5 years [28 days after the second dose]
Frequency of systemic and local adverse reactions within 28 days after the second dose of EV71 vaccine in healthy children aged 2-5 years
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy subjects aged from 2 to 5 years old as established by medical history and clinical examination
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The pre-vaccination neutralizing antibody against EV71 <1:8 which is determined by ELISA
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The subjects' guardians are able to understand and sign the informed consent
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Had never received the vaccine against EV71
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Subjects who can and will comply with the requirements of the protocol
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Subjects with temperature <37.1°C on axillary setting
Exclusion Criteria:
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Subject who has a medical history of HFMD
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<= 37 weeks gestation
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Subjects with a birth weight <2.5 kg
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Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
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Family history of seizures or progressive neurological disease
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Family history of congenital or hereditary immunodeficiency
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Severe malnutrition or dysgenopathy
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Major congenital defects or serious chronic illness, including perinatal brain damage
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Autoimmune disease
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Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
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Any acute infections in last 7 days
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Any prior administration of immunodepressant or corticosteroids in last 6month
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Any prior administration of blood products in last 3 month
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Any prior administration of other research medicines in last 1month
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Any prior administration of attenuated live vaccine in last 28 days
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Any prior administration of inactivated vaccines in last 14 days, such as pneumococcal vaccine
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Under the anti - TB prevention or therapy
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Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu | China | 210009 |
Sponsors and Collaborators
- Jiangsu Province Centers for Disease Control and Prevention
- Bejing Vigoo Biological Co., LTD
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JSVCT012