Systems Biology of Vaccination for EV71 Vaccine in Humans

This study has been completed.
Sponsor:
Collaborator:
Bejing Vigoo Biological Co., LTD
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01679665
First received: September 1, 2012
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Systems Biology
Early Gene
EV71 Vaccine
Biological: 320U /0.5ml
Biological: 0/0.5ml placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Systems Biology of Vaccination for EV71 Vaccine in Chinese Healthy Children Aged From 2 to 5 Years Old

Resource links provided by NLM:


Further study details as provided by Jiangsu Province Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine [ Time Frame: Frame: 3 days after first dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7 days after first dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days after first dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days after second dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after first dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days after the first vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days after second vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days after the first dose ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 28 days after the second dose ] [ Designated as safety issue: Yes ]
    Frequency of systemic and local adverse reactions within 28 days after the second dose of EV71 vaccine in healthy children aged 2-5 years


Enrollment: 72
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01679665

Locations
China, Jiangsu
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
  More Information

No publications provided

Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01679665     History of Changes
Other Study ID Numbers: JSVCT012
Study First Received: September 1, 2012
Last Updated: May 7, 2013
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on October 01, 2014