Clinical trial NCT05099029: A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children
Official title: A Phase III, Multiple-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of an Adjuvanted, Inactivated Enterovirus 71 (EV71) Vaccine in Healthy Infants and Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Enterovirus Infections
Keywords: Foot-and-Mouth Disease
Vaccines
Hand, foot and mouth Disease
EV71 vaccine
Lead sponsor: Enimmune Corporation
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 3982
Sex: ALL
Minimum age (years): 2
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The clinical trial designed in this Study is a placebo-controlled, double-blinded Phase III and is aimed to evaluate the vaccine efficacy, safety, immunogenicity and immune persistence of cell culture-based inactivated EV71 vaccine in children age of 2 months to \<6 years old. Two doses of Alum-adjuvanted 1.0 μg per dose of EV71 vaccine candidate will be administrated to subjects. The efficacy will be evaluated within a two year period after receiving 2-regimen vaccination by comparing the EV71-associated disease rates between the vaccine and placebo groups. Whereas, the immunogenicity will be assessed on Day 56 and Day 196, and the immune persistence will be evaluated on Day 392. Safety will be followed up to Day 392.

Eligibility criteria: Inclusion Criteria:

1. 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.
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℃.

Exclusion Criteria:

1. Subject with previous known Enterovirus 71 (EV71) infection or investigational EV71 vaccination.
2. Subject with a history of herpangina, hand-foot-mouth disease, and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 30 days.
3. 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.
4. Subject under 2 years old with gestation \<34weeks or a birth weight \<2200g.
5. History of epilepsy, seizures or non-febrile convulsions that may affect subject participation in the study in the opinion of the investigator.
6. Severe malnutrition or dysgenopathy at the screening visit.
7. Major congenital defects or serious chronic illness, including perinatal brain damage at the screening visit.
8. 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.
9. Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
10. Any acute febrile illness 3 days prior to administrating the first vaccination.
11. 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).
12. Administration of any vaccine within 14 days prior to each study vaccination.
13. Use of immunoglobulins or any blood products within 3 months prior to vaccination.
14. Chronic administration (defined as \> 14 day of continuous use) of systemic immunosuppressants, other systemic immunomodulators, or systemic corticosteroids within 6 months prior to vaccination.
15. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
16. Subject with any confirmed or suspected immunodeficiency.

Primary outcomes:
measure: The incidence rate of Hand, Foot and Mouth disease caused by EV71 after the second vaccination.
timeFrame: From 28 days after the second vaccination to two year
measure: Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
timeFrame: 28 days after the second vaccination
Secondary outcomes:
measure: The incidence rate of the severe complications and hospitalization of EV71 associated HFMD/HA disease after the second vaccination.
timeFrame: From 28 days after the second vaccination to two year
measure: Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
timeFrame: Day 0,56,196,and 392
measure: Adverse events of EV71 vaccine
timeFrame: Day 0 to Day 392
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital HsinChu Branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Pasteur Institute of HCMC
Study officials:
affiliation: Enimmune Corporation
name: Chin-Fen Yang
role: STUDY_DIRECTOR
References: