Systems Biology of Vaccination for EV71 Vaccine in Humans

Phase 2

Completed

• Conditions: Systems Biology; Early Gene; EV71 Vaccine
• Interventions: Biological: 320U /0.5ml; Biological: 0/0.5ml placebo

• Registration Number: NCT01679665
• Lead Sponsor: Jiangsu Province Centers for Disease Control and Prevention

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-01
• Study First Submitted QC: 2012-09-01
• Study First Posted: 2012-09-06
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Healthy subjects aged from 2 to 5 years old as established by medical history and clinical examination
• The pre-vaccination neutralizing antibody against EV71 <1:8 which is determined by ELISA
• The subjects' 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
• Subjects with temperature <37.1°C on axillary setting

Exclusion Criteria

• Subject who has a medical history of HFMD
• <= 37 weeks gestation
• Subjects with a birth weight <2.5 kg
• 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
• Severe malnutrition or dysgenopathy
• Major congenital defects or serious chronic illness, including perinatal brain damage
• Autoimmune disease
• Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
• Any acute infections in last 7 days
• Any prior administration of immunodepressant or corticosteroids in last 6month
• Any prior administration of blood products in last 3 month
• Any prior administration of other research medicines in last 1month
• Any prior administration of attenuated live vaccine in last 28 days
• Any prior administration of inactivated vaccines in last 14 days, such as pneumococcal vaccine
• Under the anti - TB prevention or therapy
• Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
320U /0.5ml in children (from 2 to 5 years old)	320U /0.5ml	inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 48 children aged 2-5 years old on day 0,28
0/0.5ml placebo in children (from 2 to 5 years old)	0/0.5ml placebo	0/0.5ml placebo in 24 children aged 2-5 years old on day 0, 28

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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

Trial Locations

Locations (1)

Jiangsu Provincial Center for Diseases Control and Prevention; 🇨🇳 Nanjing, Jiangsu, China