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Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam (JECEVAX-3)

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Phase 3
Locations
Vietnam
Study Type
Interventional
Intervention
JEVAX
JECEVAX
Sponsored by
National Institute of Hygiene and Epidemiology, Vietnam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Japanese Encephalitis focused on measuring Japanese Encephalitis, JECEVAX, Vietnam

Eligibility Criteria

9 Months - 24 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy children of both sexes, 9-24 months of age;
  • Have not been vaccinated with JE vaccine;
  • Parents/legally guardians agree their children to participate in the study and sign the paper informed consent.

Exclusion Criteria:

  • Currently has chronic diseases (cardiovascular, liver and spleen related etc);
  • Currently has acute diseases;
  • Use of immunocompromised treatment within 4 weeks of enrollment;
  • Being immunocompromised and autoimmune diseases (HIV, lupus);
  • The family history of immunocompromised;
  • History of febrile seizure;
  • Allergic to any vaccine component;
  • Fever (>38 Celsius degree) within 3 days before vaccination or at enrollment;
  • Malnourished (2nd grade or above);
  • Blood disorder;
  • Use of vaccines which have not been licenced 7 days before enrolment in this study

Sites / Locations

  • Hoa Binh Provincial Preventive Medicine Center
  • Hoa Binh City Health Center
  • District Health Center
  • Phu Tho Preventive Medicine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

JECEVAX

JEVAX

Arm Description

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days

JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days

Outcomes

Primary Outcome Measures

Percent of participants with treatment-related adverse events during study period.
Percent of participants with solicited and unsolicited adverse events after each dose of vaccine: immediately injection site and systemic AEs after vaccination (within 30 min), solicited AEs within 7 days after each dose, unsolicited AEs from date 1st dose 1 to date of dose 2 and from date of 2nd dose to 28-34 day post 2nd dose (3rd visit), as assessed by CTCAE v.4.0.
Percent of participants who has antibody sero-conversion in study group and control group at 28-34 days post dose 2.
Serum samples will be taken before 1 dose and 28-34 days post 2nd dose to be tested for JE antibody by PRNT.

Secondary Outcome Measures

Frequencies of participants with treatment-related SAE during study period
Frequencies of participants with treatment-related SAE during study period of JECEVAX compared to that of JEVAX, as assessed by CTCAE ver 4.0

Full Information

First Posted
July 1, 2017
Last Updated
September 14, 2018
Sponsor
National Institute of Hygiene and Epidemiology, Vietnam
Collaborators
Ministry of Science and Technology, Vietnam, Ministry of Health, Vietnam
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1. Study Identification

Unique Protocol Identification Number
NCT03282370
Brief Title
Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam
Acronym
JECEVAX-3
Official Title
Evaluate the Safety and Immunogenicity of a Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) Produced by VABIOTECH (Vietnam) in Vietnamese Children Aged 9-24 Months
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
April 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Hygiene and Epidemiology, Vietnam
Collaborators
Ministry of Science and Technology, Vietnam, Ministry of Health, Vietnam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study of the study vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess the safety of the study vaccine compares to licenced vaccine. Two hundred and twenty children are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data included immediate reaction at the injection site and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34 days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start of first dose to 28-34 days after second dose).
Detailed Description
Mouse brain-derived Japanese Encephalitis (JE) vaccine was developed in Vietnam since 1989 with the support from WHO and BIKEN institute, Japan. It helped Viet Nam prevents Japanese Encephalitis outbreaks successfully during those years. However, mouse brain-derived JE vaccine production requires companies to compliance various requirements from WHO. Especially, WHO has a plan to replace the mouse brain-derived JE vaccines with Cell culture-derived JE vaccines. Vero cell-derived vaccine technology shows many advantages compares to Mouse brain-derived vaccine technology. VABIOTECH has been approved and sponsored by the Ministry of Science and Technology to produce Vero cell - derived JE vaccine. The vaccine demonstrated a good safety and immunogenicity profile in animal models. The vaccine has been proven safety in volunteer adults and in phase 2 which evaluated the safety and immunogenicity of 3 difference antigen concentrations. In this study, a selected dose of the studied vaccine (JECEVAX) derived from phase 2 will be compared the safety with a licensed vaccine (JEVAX-VABIOTECH Vietnam) in Vietnamese children, aged 9-24 months to assess the safety and immunogenicity. Two hundred and twenty children are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2 doses of investigate vaccines or control vaccine subcutaneously, at 28-34 days interval. Safety data included immediate reaction at the injection site and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34 days after first dose (up to date of 2nd dose) and from the second dose to 28-34 days after 2nd dose (up to date of 3rd visit). SAE (from start of first dose to 28-34 days after second dose - date of 3rd visit).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
Keywords
Japanese Encephalitis, JECEVAX, Vietnam

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
655 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JECEVAX
Arm Type
Experimental
Arm Description
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
Arm Title
JEVAX
Arm Type
Active Comparator
Arm Description
JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
Intervention Type
Biological
Intervention Name(s)
JEVAX
Intervention Description
JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 28-34 days interval
Intervention Type
Biological
Intervention Name(s)
JECEVAX
Intervention Description
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
Primary Outcome Measure Information:
Title
Percent of participants with treatment-related adverse events during study period.
Description
Percent of participants with solicited and unsolicited adverse events after each dose of vaccine: immediately injection site and systemic AEs after vaccination (within 30 min), solicited AEs within 7 days after each dose, unsolicited AEs from date 1st dose 1 to date of dose 2 and from date of 2nd dose to 28-34 day post 2nd dose (3rd visit), as assessed by CTCAE v.4.0.
Time Frame
Up to 28-34 days after 2nd dose
Title
Percent of participants who has antibody sero-conversion in study group and control group at 28-34 days post dose 2.
Description
Serum samples will be taken before 1 dose and 28-34 days post 2nd dose to be tested for JE antibody by PRNT.
Time Frame
Up to 28-34 days after 2nd dose
Secondary Outcome Measure Information:
Title
Frequencies of participants with treatment-related SAE during study period
Description
Frequencies of participants with treatment-related SAE during study period of JECEVAX compared to that of JEVAX, as assessed by CTCAE ver 4.0
Time Frame
Up to 28-34 days after the 2nd dose (3rd visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy children of both sexes, 9-24 months of age; Have not been vaccinated with JE vaccine; Parents/legally guardians agree their children to participate in the study and sign the paper informed consent. Exclusion Criteria: Currently has chronic diseases (cardiovascular, liver and spleen related etc); Currently has acute diseases; Use of immunocompromised treatment within 4 weeks of enrollment; Being immunocompromised and autoimmune diseases (HIV, lupus); The family history of immunocompromised; History of febrile seizure; Allergic to any vaccine component; Fever (>38 Celsius degree) within 3 days before vaccination or at enrollment; Malnourished (2nd grade or above); Blood disorder; Use of vaccines which have not been licenced 7 days before enrolment in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thiem D Vu, MD., PhD.
Organizational Affiliation
National Institute of Hygiene and Epidemiology, Vietnam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoa Binh Provincial Preventive Medicine Center
City
Hòa Bình
State/Province
Hoa Binh
ZIP/Postal Code
350000
Country
Vietnam
Facility Name
Hoa Binh City Health Center
City
Hòa Bình
State/Province
Hoa Binh
ZIP/Postal Code
35000
Country
Vietnam
Facility Name
District Health Center
City
Thanh Son
State/Province
Phu Tho
Country
Vietnam
Facility Name
Phu Tho Preventive Medicine Center
City
Viet tri
State/Province
Phu Tho
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual data with identification removed are to be available for Ethical committee, Ministry of Health and National Foundation of Science and Technology Development to avoid misuse of data. Public shared data will be in the form of summarised tables and figures.

Learn more about this trial

Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam

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