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

Enterovirus Infections Clinical Trial

Official title:

An Open-Label, Dose-Finding, Phase II Study to Evaluate the Immunogenicity and Safety of the Bioreactor-generated EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 2 to 35 Months Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268083
• Other study ID #: EV-BR1501
• Status: Completed
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: October 2021
• Source: Enimmune Corporation
• Contact: n/a
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 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,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.

Related Conditions & MeSH terms

• Enterovirus Infections

Intervention

Biological:
• EV71 vaccine ([0.5 µg total protein + adjuvant 150 µg AI(OH)3] per dose)
Two vaccinations at 28 days apart
• EV71 vaccine ([1 µg total protein + adjuvant 150 µg AI(OH)3] 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	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Enimmune Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum neutralizing antibody titers (NT) induced by the EV71 vaccine	Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 56	Day 56
Primary	Seroconversion rate (SCR) based on neutralizing antibody titers	Evaluate the immunogenicity change of SCR from baseline on Day 56	Day 56
Primary	Serum neutralizing antibody titers (NT) induced by the EV71 vaccine	Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 28	Day 28
Primary	Serum neutralizing antibody titers (NT) induced by the EV71 vaccine	Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 196	Day 196
Primary	Seroconversion rate (SCR) based on neutralizing antibody titers	Evaluate the immunogenicity change of SCR from baseline on Day 28	Day 28
Primary	Seroconversion rate (SCR) based on neutralizing antibody titers	Evaluate the immunogenicity change of SCR from baseline on Day 196	Day 196
Secondary	Solicited adverse events		7 days after each vaccination
Secondary	Unsolicited adverse events		28 days after each vaccination
Secondary	The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)		Day 0 to Day 196
Secondary	The occurrence of EV 71 breakthrough infection after Visit 3		Day 57 to Day 364
Secondary	Serum neutralizing antibody titers (NT) induced by the EV71 vaccine	Evaluate the immunogenicity of serum neutralization antibody titer induced by the EV 71 vaccine on Day 364	Day 364