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

Enterovirus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777411
• Other study ID #: EV-RB1401
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2016
• Last updated: November 28, 2016
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: Enimmune Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Enterovirus Infections

Intervention

Biological:
• EV71 vaccine ([0.5 µg total protein + adjuvant 150 µg AIPO4] per dose)
Two vaccinations at 28 days apart
• EV71 vaccine ([1 µg total protein + adjuvant 150 µg AIPO4] per dose)
Two vaccinations at 28 days apart
• EV71 vaccine ([2 µg total protein + adjuvant 150 µg AIPO4] per dose)
Two vaccinations at 28 days apart
• EV71 vaccine (2 µg total protein per dose)
Two vaccinations at 28 days apart
• EV71 vaccine ([0.5 µg total protein + adjuvant 150 µg AIPO4] per dose)
Two vaccinations at 28 days apart
• EV71 vaccine ([1 µg total protein + adjuvant 150 µg AIPO4] per dose)
Two vaccinations at 28 days apart
• EV71 vaccine (1 µg total protein per dose)
Two vaccinations at 28 days apart

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Tao Yuan

Sponsors (1)

Lead Sponsor	Collaborator
Enimmune Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Solicited adverse events		7 days after each vaccination	Yes
Primary	Unsolicited adverse events		28 days after each vaccination	Yes
Primary	The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)		Day 0 to Day 196	Yes
Secondary	immunoglobulin G (IgG) titers induced by the EV71 vaccine ( determined by ELISA)		Day 28, Day 56, Day 196	No
Secondary	serum neutralizing antibody titers (NT) induced by the EV71 vaccine		Day 28, Day 56, Day 196	No
Secondary	Seroconversion rate (SCR) based on neutralizing antibody titers		Day 28, Day 56, Day 196	No
Secondary	change in the laboratory results based on hematology tests in each visit		Day 28, Day 56, Day 196	Yes
Secondary	change in the laboratory results based on biochemistry tests in each visit		Day 28, Day 56, Day 196	Yes
Secondary	change in heart rates at each visit (for the 3 to 6 years old group only)		Day 28, Day 56, Day 196	Yes
Secondary	change in blood pressures at each visit (for the 3 to 6 years old group only)		Day 28, Day 56, Day 196	Yes