Early Gene, EV71 Vaccine, Systems Biology
Conditions
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.
Interventions
BIOLOGICAL320U /0.5ml
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 4 weeks interval
BIOLOGICAL0/0.5ml placebo
0/0.5ml placebo, two doses, 4 weeks interval
Sponsors
Bejing Vigoo Biological Co., LTD
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine | Frame: 3 days after first dose | Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 3 in children aged 2-5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 first dose | Frequency of systemic and local adverse reactions within 28 days after the first dose of EV71 vaccine in healthy children aged 2-5 years |
Countries
China
Outcome results
None listed