Safety and Immunogenicity of JECEVAX in Young Children

June 24, 2016 updated by: Vu Dinh Thiem, National Institute of Hygiene and Epidemiology, Vietnam

Safety and Immunogenicity of an Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Vietnamese Children

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Phu Tho
      • Thanh Son, Phu Tho, Vietnam
        • District Health Center
      • Viet tri, Phu Tho, Vietnam
        • Phu Tho Preventive Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 2 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: JECEVAX-1
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1.0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12days
Biological: JECEVAX-1
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Other Names:
  • JECEVAX-HI
EXPERIMENTAL: JECEVAX-0.8
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Biological: JECEVAX-0.8
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Other Names:
  • JECVAX-MED
EXPERIMENTAL: JECEVAX-0.5
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Biological: JECEVAX-0.5
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Other Names:
  • JECEVAX-LOW
ACTIVE_COMPARATOR: JEVAX
JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Biological: JEVAX
JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 10-12 days interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events during study period.
Time Frame: Up to 30 days after 2nd dose
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.
Up to 30 days after 2nd dose
Number of participants have sero-conversion at 20-22 days post 2nd dose (compared to pre-vaccination)
Time Frame: Up to 20-22 days after the 2nd dose
Sero-conversion rate of each JECEVAX regimen and JEVAX at 20-22 days after 2 doses of vaccines
Up to 20-22 days after the 2nd dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related SAE during study period
Time Frame: Up to 30 days after the 2nd dose
Number of participants with treatment-related SAE during study period of JECEVAX compared to that of JEVAX, as assessed by CTCAE ver 4.0
Up to 30 days after the 2nd dose
Number of participants with abnormal laboratory value.
Time Frame: Up to 20-22 days after the 2nd dose.
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.
Up to 20-22 days after the 2nd dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Hygiene and Epidemiology, Vietnam

Collaborators

Ministry of Health, Vietnam
Ministry of Science and Technology, Vietnam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (ESTIMATE)

June 28, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-JECEVAX-2R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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