Clinical trial NCT02777411: A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
Official title: An Open-label, Dose-finding, Phase II Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Enterovirus Infections
Keywords: Vaccines
Hand, Foot and Mouth Disease
EV71 enteroviruses vaccine
Lead sponsor: Enimmune Corporation
Sponsor class: INDUSTRY
First posted: 2016-05-19
Enrollment: 122
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.


Eligibility criteria: Inclusion Criteria:

1. Healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and \< 7 years old) for Part A; from 6 to 35 months old (i.e. ≥ 6 months old and \< 36 months old) for Part B at the time of first vaccination.
2. Subject's guardians were able and willing to comply with study procedures and give written informed consent.
3. Subject was able and could comply with the requirements of the protocol.
4. Subject with body temperature ≤38°C.

Exclusion Criteria:

1. Subject with previous known exposure to Enterovirus 71 (EV71).
2. Subject with a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
3. Subject with gestation \< 37 weeks.
4. Subject with birth weight \<2.5 kg.
5. Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
6. Family history of seizures or progressive neurological disease.
7. Family history of congenital or hereditary immunodeficiency.
8. Severe malnutrition or dysgenopathy.
9. Major congenital defects or serious chronic illness, including perinatal brain damage.
10. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura).
11. Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws.
12. Any acute infections 7 days prior to administrate the first vaccination.
13. Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period.
14. Administration of any attenuated live vaccine within 7 days prior to vaccination.
15. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
16. Chronic administration (defined as \> 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination.
17. Under anti-tuberculosis prevention or therapy.
18. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.

Primary outcomes:
measure: Solicited adverse events
timeFrame: 7 days after each vaccination
measure: Unsolicited adverse events
timeFrame: 28 days after each vaccination
measure: The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)
timeFrame: Day 0 to Day 196
Secondary outcomes:
measure: immunoglobulin G (IgG) titers induced by the EV71 vaccine ( determined by ELISA)
timeFrame: Day 28, Day 56, Day 196
measure: serum neutralizing antibody titers (NT) induced by the EV71 vaccine
timeFrame: Day 28, Day 56, Day 196
measure: Seroconversion rate (SCR) based on neutralizing antibody titers
timeFrame: Day 28, Day 56, Day 196
measure: change in the laboratory results based on hematology tests in each visit
timeFrame: Day 28, Day 56, Day 196
measure: change in the laboratory results based on biochemistry tests in each visit
timeFrame: Day 28, Day 56, Day 196
measure: change in heart rates at each visit (for the 3 to 6 years old group only)
timeFrame: Day 28, Day 56, Day 196
measure: change in blood pressures at each visit (for the 3 to 6 years old group only)
timeFrame: Day 28, Day 56, Day 196
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Tao Yuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
References: