Clinical Trials List
Protocol NumberEV-BR1501
NCT Number(ClinicalTrials.gov Identfier)NCT03268083
2016-02-01 - 2017-03-31
Phase II
Terminated1
ICD-10B08.4
Enteroviral vesicular stomatitis with exanthem
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
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Trial Applicant
STATPLUS, INC.
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Sponsor
Enimmune Corporation
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 黃文嬋 Division of Pediatrics
- Chun-yi Lu Division of Pediatrics
- 蔡幸真 Division of Pediatrics
- 賴貞吟 Division of Pediatrics
- Luan-Yin Chang Division of Pediatrics
- 楊宗儒 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Enterovirus Infections (EV71)
Objectives
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.
Test Drug
EV71 Vaccine
Active Ingredient
total protein + adjuvant Al(OH)3
Dosage Form
Injection
Dosage
0.5 μg/ 1μg total protein + adjuvant 150 μg Al(OH)3
Endpoints
1. Primary endpoint:
(1) Evaluate the immunogenicity change of serum neutralizing antibody titers induced by
the EV71 vaccine from baseline on Day 28, Day 56 and Day 196.
(2) Evaluate the immunogenicity change of seroconversion rate* (SCR) from baseline on
Day 28, Day 56 and Day 196.
* SCR is defined as the percentage of subjects achieving either a pre-vaccination neutralizing
antibody titer <1:8 and a post-vaccination neutralizing antibody titer ≥1:32 OR a
pre-vaccination neutralizing antibody titer ≥1:8 and a minimum 4-fold increase in
post-vaccination neutralizing antibody titer.
2. Secondary endpoints:
(1) The percentage, intensity and relationship to vaccination of local and systemic signs
and symptoms after the first and second vaccination, respectively:
o Solicited adverse events: during 7-days follow-up period
o Unsolicited adverse events: during 28-days follow-up period
o The occurrence of overall AEs and SAEs till Visit 4
(2) The change in the laboratory results in each visit till Visit 4:
o Hematology
o Biochemistry
(3) The change in vital signs post vaccination in each visit:
o Heart rate (HR), for the 3 to 6 years old group only
o Blood pressure (BP), for the 3 to 6 years old group only
(4) The occurrence of EV 71 breakthrough infection after Visit 3.
(5) To evaluate the immunogenicity of serum neutralization antibody titer induced by the
EV 71 vaccine on Visit 5.
(1) Evaluate the immunogenicity change of serum neutralizing antibody titers induced by
the EV71 vaccine from baseline on Day 28, Day 56 and Day 196.
(2) Evaluate the immunogenicity change of seroconversion rate* (SCR) from baseline on
Day 28, Day 56 and Day 196.
* SCR is defined as the percentage of subjects achieving either a pre-vaccination neutralizing
antibody titer <1:8 and a post-vaccination neutralizing antibody titer ≥1:32 OR a
pre-vaccination neutralizing antibody titer ≥1:8 and a minimum 4-fold increase in
post-vaccination neutralizing antibody titer.
2. Secondary endpoints:
(1) The percentage, intensity and relationship to vaccination of local and systemic signs
and symptoms after the first and second vaccination, respectively:
o Solicited adverse events: during 7-days follow-up period
o Unsolicited adverse events: during 28-days follow-up period
o The occurrence of overall AEs and SAEs till Visit 4
(2) The change in the laboratory results in each visit till Visit 4:
o Hematology
o Biochemistry
(3) The change in vital signs post vaccination in each visit:
o Heart rate (HR), for the 3 to 6 years old group only
o Blood pressure (BP), for the 3 to 6 years old group only
(4) The occurrence of EV 71 breakthrough infection after Visit 3.
(5) To evaluate the immunogenicity of serum neutralization antibody titer induced by the
EV 71 vaccine on Visit 5.
Inclution Criteria
Main 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.
(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
Main 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.
(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.
The Estimated Number of Participants
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Taiwan
84 participants
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Global
0 participants
