A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects

Phase 2

Completed

• Conditions: Enterovirus Infections
• Interventions: Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose); Biological: EV71 vaccine ([1 μg total protein ] per dose); Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)

• Registration Number: NCT03268083
• 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 Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-04
• Primary Completion: 2017-08
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Study Completion: 2017-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and < 7 years old) for Part A,and from 2 to 35 months old (i.e. ≥ 2 months old and < 36 months old) for Part B at the time of first vaccination.
2. Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
3. Subject is able and can 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,and 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 hemostatic difficulties with IM injections or blood draws.
12. Any acute infections 7 days prior to administrating 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 vaccines within 14 days prior to randomization.
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 or planned use during the study period.
17. Subjects who had ever received investigational EV-71 vaccine prior to randomization.
18. Under anti-tuberculosis prevention or therapy.
19. 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 AI(OH)3] per dose)	3 to 6 years
Group A3	EV71 vaccine ([1 μg total protein ] per dose)	3 to 6 years
Group B2	EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)	2 to 35 months
Group A2	EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)	3 to 6 years
Group B3	EV71 vaccine ([1 μg total protein ] per dose)	2 to 35 months
Group B1	EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)	2 to 35 months

Primary Outcome Measures

Name	Time	Method
Seroconversion rate (SCR) based on neutralizing antibody titers	Day 196	Evaluate the immunogenicity change of SCR from baseline on Day 196
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine	Day 196	Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 196

Secondary Outcome Measures

Name	Time	Method
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine	Day 364	Evaluate the immunogenicity of serum neutralization antibody titer induced by the EV 71 vaccine on Day 364
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
The occurrence of EV 71 breakthrough infection after Visit 3	Day 57 to Day 364

Trial Locations

Locations (4)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan