Systems Biology of Vaccination for EV71 Vaccine in Humans

NCT01679665 | Completed Phase 2

• 1 other identifier: JSVCT012
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Systems Biology; Early Gene; EV71 Vaccine

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (4)

• 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 after second vaccination

  28 days after second vaccination

• the safety of EV71 vaccine in healthy children aged 2-5 years

  28 days after the first dose

• the safety of EV71 vaccine in healthy children aged 2-5 years

  28 days after the second dose

Study Arms (2)

320U /0.5ml in children (from 2 to 5 years old)

EXPERIMENTAL

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

0/0.5ml placebo in children (from 2 to 5 years old)

PLACEBO COMPARATOR

0/0.5ml placebo in 24 children aged 2-5 years old on day 0, 28

Biological: 0/0.5ml placebo

Interventions

320U /0.5ml BIOLOGICAL

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

320U /0.5ml in children (from 2 to 5 years old)

0/0.5ml placebo BIOLOGICAL

0/0.5ml placebo, two doses, 4 weeks interval

0/0.5ml placebo in children (from 2 to 5 years old)

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Bejing Vigoo Biological Co., LTD: collaborator

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2012
• First Posted: September 6, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

CN (1)