Systems Biology of Vaccination for EV71 Vaccine in Humans

Systems Biology Clinical Trial

Official title:

Systems Biology of Vaccination for EV71 Vaccine in Chinese Healthy Children Aged From 2 to 5 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679665
• Other study ID #: JSVCT012
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2012
• Last updated: May 7, 2013
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Early Gene
• EV71 Vaccine
• Systems Biology

Intervention

Biological:
• 320U /0.5ml
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 4 weeks interval
• 0/0.5ml placebo
0/0.5ml placebo, two doses, 4 weeks interval

Locations

Country	Name	City	State
China	Jiangsu Provincial Center for Diseases Control and Prevention	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	Bejing Vigoo Biological Co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine	Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 3 in children aged 2-5 years	Frame: 3 days after first dose	No
Primary	Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine	Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 7 in children aged 2-5 years	7 days after first dose	No
Primary	Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine	Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 28 in children aged 2-5 years	28 days after first dose	No
Primary	Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine	Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 56 in children aged 2-5 years	28 days after second dose	No
Primary	Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine	Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at month 6 in children aged 2-5 years	6 months after first dose	No
Secondary	GMT, seroconversion rate of anti-EV71 antibodies in serum after first vaccination	GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination	28 days after the first vaccination	No
Secondary	GMT, seroconversion rate of anti-EV71 antibodies in serum after second vaccination	GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination	28 days after second vaccination	No
Secondary	the safety of EV71 vaccine in healthy children aged 2-5 years	Frequency of systemic and local adverse reactions within 28 days after the first dose of EV71 vaccine in healthy children aged 2-5 years	28 days after the first dose	Yes
Secondary	the safety of EV71 vaccine in healthy children aged 2-5 years	Frequency of systemic and local adverse reactions within 28 days after the second dose of EV71 vaccine in healthy children aged 2-5 years	28 days after the second dose	Yes