Clinical trial NCT01679665: Systems Biology of Vaccination for EV71 Vaccine in Humans
Official title: Systems Biology of Vaccination for EV71 Vaccine in Chinese Healthy Children Aged From 2 to 5 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systems Biology
Early Gene
EV71 Vaccine
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Bejing Vigoo Biological Co., LTD
First posted: 2012-09-06
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility 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

Primary outcomes:
measure: Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
timeFrame: Frame: 3 days after first dose
measure: Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
timeFrame: 7 days after first dose
measure: Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
timeFrame: 28 days after first dose
measure: Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
timeFrame: 28 days after second dose
measure: Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine
timeFrame: 6 months after first dose
Secondary outcomes:
measure: GMT, seroconversion rate of anti-EV71 antibodies in serum after first vaccination
timeFrame: 28 days after the first vaccination
measure: GMT, seroconversion rate of anti-EV71 antibodies in serum after second vaccination
timeFrame: 28 days after second vaccination
measure: the safety of EV71 vaccine in healthy children aged 2-5 years
timeFrame: 28 days after the first dose
measure: the safety of EV71 vaccine in healthy children aged 2-5 years
timeFrame: 28 days after the second dose
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Center for Diseases Control and Prevention
state: Jiangsu
Study officials:
References: