A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children

NCT05099029 | Active Not Recruiting Phase 3

• 1 other identifier: EV-BR1701
• Study Type: interventional
• Target: 3,982
• Locations: 2 countries
• Sites: 8

Brief Summary

The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.

Conditions

Enterovirus Infections

Keywords

Foot-and-Mouth Disease; Vaccines; Hand, foot and mouth Disease; EV71 vaccine

Outcome Measures

Primary Outcomes (2)

• The incidence rate of Hand, Foot and Mouth disease caused by EV71 after the second vaccination.

  Evaluate the efficacy of EV71 vacccine against HFMD caused by EV71

  From 28 days after the second vaccination to two year

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

  Evaluate the immunogenicity by the response rate

  28 days after the second vaccination

Secondary Outcomes (3)

• The incidence rate of the severe complications and hospitalization of EV71 associated HFMD/HA disease after the second vaccination.

  From 28 days after the second vaccination to two year

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

  Day 0,56,196,and 392

• Adverse events of EV71 vaccine

  Day 0 to Day 392

Study Arms (2)

EV71 Vaccine

EXPERIMENTAL

Biological: EV71 vaccine

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

EV71 vaccine BIOLOGICAL

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

EV71 Vaccine

Placebo BIOLOGICAL

Placebo (\[ adjuvant 150 μg AI(OH)3\] per dose) Two vaccinations at 28 days apart

Placebo

Eligibility Criteria

• Age: 2 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged from 2 months to 6 years old (i.e. \>= 2 months old and \< 7 years old) 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℃.

You may not qualify if:

• Subject with previous known Enterovirus 71 (EV71) infection or investigational EV71 vaccination.
• Subject with a history of herpangina, hand-foot-mouth disease, and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 30 days.
• 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.
• Subject under 2 years old with gestation \<34weeks or a birth weight \<2200g.
• History of epilepsy, seizures or non-febrile convulsions that may affect subject participation in the study in the opinion of the investigator.
• Severe malnutrition or dysgenopathy at the screening visit.
• Major congenital defects or serious chronic illness, including perinatal brain damage at the screening visit.
• 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) that may affect subject participation in the study in the opinion of the investigator.
• Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
• Any acute febrile illness 3 days prior to administrating the first vaccination.
• Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during Visit 1 to Visit 4 (Day 0 to Day 196).
• Administration of any vaccine within 14 days prior to each study vaccination.
• Use of immunoglobulins or any blood products within 3 months prior to vaccination.
• Chronic administration (defined as \> 14 day of continuous use) of systemic immunosuppressants, other systemic immunomodulators, or systemic corticosteroids within 6 months prior to vaccination.
• Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.

Sponsors & Collaborators

• Enimmune Corporation: lead

Study Sites (8)

Changhua Christian Hospital

Changhua, Taiwan

Location

National Taiwan University Hospital HsinChu Branch

Hsinchu, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Pasteur Institute of HCMC

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Enterovirus Infections; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Animal Diseases; Coxsackievirus Infections

Study Officials

• Chin-Fen Yang

  Enimmune Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 29, 2021
• Study Start: June 27, 2018
• Primary Completion: August 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

TW (7); VN (1)