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

Enimmune Corporation4 sites in 1 country140 target enrollmentJuly 2016

ConditionsEnterovirus Infections

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Enterovirus Infections
Sponsor: Enimmune Corporation
Enrollment: 140
Locations: 4
Primary Endpoint: Seroconversion rate (SCR) based on neutralizing antibody titers
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

December 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Enimmune Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
•Subject is able and can comply with the requirements of the protocol.
•Subject with body temperature ≤38°C.

Exclusion Criteria

•Subject with previous known exposure to Enterovirus 71 (EV71).
•Subject with a history of herpangina, hand-foot-mouth disease,and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
•Subject with gestation \< 37 weeks.
•Subject with birth weight \<2.5 kg.
•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.
•Family history of seizures or progressive neurological disease.
•Family history of congenital or hereditary immunodeficiency.
•Severe malnutrition or dysgenopathy.
•Major congenital defects or serious chronic illness, including perinatal brain damage.
•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).

Outcomes

Primary Outcomes

Seroconversion rate (SCR) based on neutralizing antibody titers

Time Frame: Day 196

Evaluate the immunogenicity change of SCR from baseline on Day 196

Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

Time Frame: Day 196

Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 196

Secondary Outcomes

Serum neutralizing antibody titers (NT) induced by the EV71 vaccine(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)