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Safety and Immunogenicity of JECEVAX in Young Children

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
JEVAX
JECEVAX-1
JECEVAX-0.8
JECEVAX-0.5
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;
  • Not have any chronic disease;
  • Parents/legal guardians agree to participate their children in this study and sign the informed consent.

Exclusion Criteria:

  • Currently has chronic diseases (cardiovascular, liver and spleen related etc);
  • Currently has acute diseases;
  • Use (orally or injection) with corticosteroid containing drug (>1 mg / kg dose);
  • 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 (3rd grade or above);
  • Blood disorder;
  • Use of vaccines which have not been licenced 7 days before enrolment in this study

Sites / Locations

  • District Health Center
  • Phu Tho Preventive Medicine Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

JECEVAX-1

JECEVAX-0.8

JECEVAX-0.5

JEVAX

Arm Description

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1.0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12days

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events during study period.
Number 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 and unsolicited AEs within 7 days after each dose, unsolicited AEs from day 8 after dose 1 to date of dose 2 and from day 8 after dose 2 to day 30 post 2nd dose, as assessed by CTCAE v.4.0.
Number of participants have sero-conversion at 20-22 days post 2nd dose (compared to pre-vaccination)
Sero-conversion rate of each JECEVAX regimen and JEVAX at 20-22 days after 2 doses of vaccines

Secondary Outcome Measures

Number of participants with treatment-related SAE during study period
Number of participants with treatment-related SAE during study period of JECEVAX compared to that of JEVAX, as assessed by CTCAE ver 4.0
Number of participants with abnormal laboratory value.
Numbers of participants with abnormal laboratory values (blood cell counts, urea concentration, liver function (ALT, AST concentration) when administered with different JECEVAX formulations and with JEVAX before the first dose and 20-22 days after the 2nd dose.

Full Information

First Posted
June 23, 2016
Last Updated
June 24, 2016
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
NCT02816554
Brief Title
Safety and Immunogenicity of JECEVAX in Young Children
Official Title
Safety and Immunogenicity of an Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Vietnamese Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (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

Data Monitoring Committee
No

5. Study Description

Brief Summary
A dose escalating study with 3 different dosing regimens of the studied 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 and immunogenicity. Two hundred children are enrolled and randomly assigned into 4 groups (50 children/group), each of which receive 2 doses of study / control vaccine subcutaneously, at 10-12 days interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the first dose to 30 days after second dose; SAE (from start of first dose to 30 days after second dose), blood cell count, urea, ALT, AST. Immunogenicity outcomes include seroconversion of neutralizing antibodies (blood samples are taken prior to 1st dose and 20-22 days post 2nd 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. In this study, a dose escalating study with 3 different dosing regimens of the studied vaccine (JECEVAX) and a licensed vaccine (JEVAX-VABIOTECH Vietnam) is conducted in Vietnamese children, aged 9-24 months to assess the safety and immunogenicity. Two hundred children are enrolled and randomly assigned into 4 groups (50 children/group), each of which receive 2 doses of investigate vaccines or control vaccine subcutaneously, at 10-12 days interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the first dose to 30 days after second dose; SAE (from start of first dose to 30 days after second dose), blood cell count, urea, ALT, AST. Immunogenicity outcomes include seroconversion of neutralizing antibodies (blood samples are taken prior to 1st dose and 20-22 days post 2nd dose).

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JECEVAX-1
Arm Type
Experimental
Arm Description
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1.0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12days
Arm Title
JECEVAX-0.8
Arm Type
Experimental
Arm Description
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Arm Title
JECEVAX-0.5
Arm Type
Experimental
Arm Description
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 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 10-12 days
Intervention Type
Biological
Intervention Name(s)
JEVAX
Intervention Description
JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 10-12 days interval
Intervention Type
Biological
Intervention Name(s)
JECEVAX-1
Other Intervention Name(s)
JECEVAX-HI
Intervention Description
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Intervention Type
Biological
Intervention Name(s)
JECEVAX-0.8
Other Intervention Name(s)
JECVAX-MED
Intervention Description
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Intervention Type
Biological
Intervention Name(s)
JECEVAX-0.5
Other Intervention Name(s)
JECEVAX-LOW
Intervention Description
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events during study period.
Description
Number 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 and unsolicited AEs within 7 days after each dose, unsolicited AEs from day 8 after dose 1 to date of dose 2 and from day 8 after dose 2 to day 30 post 2nd dose, as assessed by CTCAE v.4.0.
Time Frame
Up to 30 days after 2nd dose
Title
Number of participants have sero-conversion at 20-22 days post 2nd dose (compared to pre-vaccination)
Description
Sero-conversion rate of each JECEVAX regimen and JEVAX at 20-22 days after 2 doses of vaccines
Time Frame
Up to 20-22 days after the 2nd dose
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related SAE during study period
Description
Number 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 30 days after the 2nd dose
Title
Number of participants with abnormal laboratory value.
Description
Numbers of participants with abnormal laboratory values (blood cell counts, urea concentration, liver function (ALT, AST concentration) when administered with different JECEVAX formulations and with JEVAX before the first dose and 20-22 days after the 2nd dose.
Time Frame
Up to 20-22 days after the 2nd dose.

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; Not have any chronic disease; Parents/legal guardians agree to participate their children in this study and sign the informed consent. Exclusion Criteria: Currently has chronic diseases (cardiovascular, liver and spleen related etc); Currently has acute diseases; Use (orally or injection) with corticosteroid containing drug (>1 mg / kg dose); 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 (3rd 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
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

Safety and Immunogenicity of JECEVAX in Young Children

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