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

Phase 2

Completed

• Conditions: Enterovirus Infections
• Interventions: Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose); Biological: EV71 vaccine (2 μg total protein per dose); Biological: EV71 vaccine (1 μg total protein per dose); Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose); Biological: EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)

• Registration Number: NCT02777411
• Lead Sponsor: Enimmune Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-19
• Status Verified: 2016-08
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A1	EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)	3 to 6 years
Group A4	EV71 vaccine (2 μg total protein per dose)	3 to 6 years
Group B4	EV71 vaccine (1 μg total protein per dose)	6 to 35 months
Group A2	EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)	3 to 6 years
Group B2	EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)	6 to 35 months
Group B3	EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)	6 to 35 months
Group A3	EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)	3 to 6 years

Primary Outcome Measures

Name	Time	Method
Unsolicited adverse events	28 days after each vaccination
Solicited adverse events	7 days after each vaccination
The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)	Day 0 to Day 196

Secondary Outcome Measures

Name	Time	Method
immunoglobulin G (IgG) titers induced by the EV71 vaccine ( determined by ELISA)	Day 28, Day 56, Day 196
serum neutralizing antibody titers (NT) induced by the EV71 vaccine	Day 28, Day 56, Day 196
change in the laboratory results based on hematology tests in each visit	Day 28, Day 56, Day 196
change in blood pressures at each visit (for the 3 to 6 years old group only)	Day 28, Day 56, Day 196
Seroconversion rate (SCR) based on neutralizing antibody titers	Day 28, Day 56, Day 196
change in the laboratory results based on biochemistry tests in each visit	Day 28, Day 56, Day 196
change in heart rates at each visit (for the 3 to 6 years old group only)	Day 28, Day 56, Day 196

Trial Locations

Locations (4)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Tao Yuan, Taiwan