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Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

Primary Purpose

Japanese Encephalitis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
ChimeriVax™-JE
Japanese Encephalitis Inactivated Mouse Brain Vaccine
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

9 Months - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All aspects of the Protocol explained and written informed consent obtained from the subject's parent or guardian and assent from the child if ≥ 8 years of age.
  • Aged ≥ 9 months to < 10 years
  • In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results
  • Subject had to be available for the study duration for the study duration, including all planned follow-up visits.

Exclusion Criteria:

  • A history of vaccination against, or infection with, JE or other flaviviruses (e.g. Kyanasur Forest Disease, West Nile virus, dengue fever). Previous JE vaccination was to be determined by history (interview of subject's parent or guardian) or by inspecting the child's official vaccination record.
  • Demonstration of parasitemia on malaria blood smear at Screening.
  • History of residence in or travel to a JE-endemic region of India or elsewhere in Asia (for periods of 4 weeks or more).
  • hypersensitivity to thimerosal or gelatin
  • Have received a transfusion of blood, blood products or serum globulin in the preceding 6 months,
  • Have an immunodeficiency or neurological disorder, or take drugs that suppress the immune system,
  • Have a history of severe reaction to other vaccines,
  • Have a chronic condition requiring medication,
  • Intend to travel out of the area during the study period,
  • Have spent at least 4 weeks in a JE-endemic region,
  • Plan to receive any other vaccination within the double-blind treatment period, or who have received a vaccination in the month preceding Screening,
  • Exhibit signs of secondary or tertiary malnutrition,
  • Are seropositive to human immunodeficiency virus (HIV), Hepatitis B or C,
  • Have malaria infection, or who have a fever within 3 days before vaccination.
  • Those with an acute fever, or with previously scheduled vaccinations, may be rescheduled.
  • Consideration of the routine immunisation schedule should be made such that it is ensured that routine vaccinations due are either given before entry to the trial, or afterwards if delayed because of the trial.

Sites / Locations

  • Dr Atul's Child Hospital
  • Government Medical College
  • Maulana Azad Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

JE-CV Group

MBDV Group

Arm Description

Participants will receive Japanese encephalitis chimeric virus vaccine (JE-CV)

Participants will receive the mouse brain-derived vaccine (MBDV)

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).

Secondary Outcome Measures

Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).

Full Information

First Posted
February 27, 2007
Last Updated
July 24, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00441259
Brief Title
Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age
Official Title
Randomised, Double Blind, Controlled, Safety, Tolerability and Immunogenicity Phase II Trial of ChimeriVax™-JE and Japanese Encephalitis Inactivated Mouse Brain Vaccine in Children of Descending Age.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period. Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JE-CV Group
Arm Type
Experimental
Arm Description
Participants will receive Japanese encephalitis chimeric virus vaccine (JE-CV)
Arm Title
MBDV Group
Arm Type
Active Comparator
Arm Description
Participants will receive the mouse brain-derived vaccine (MBDV)
Intervention Type
Biological
Intervention Name(s)
ChimeriVax™-JE
Intervention Description
One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged > 3 years and 0.5 ml to children and infants aged < 3 years administered subcutaneously
Intervention Type
Biological
Intervention Name(s)
Japanese Encephalitis Inactivated Mouse Brain Vaccine
Intervention Description
Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged > 3 years and 0.5 ml is given to children and infants aged < 3 years administered subcutaneously
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time Frame
Day 14 up to Day 42 Post-vaccination
Title
Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Time Frame
Day 14 up to Day 42 Post-vaccination
Title
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Description
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Time Frame
Day 42 Post-vaccination
Title
Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Description
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Time Frame
Day 42 Post Dose 1
Secondary Outcome Measure Information:
Title
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Description
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).
Time Frame
Day 42 Post Dose 1
Title
Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine
Description
Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).
Time Frame
Day 42 Post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All aspects of the Protocol explained and written informed consent obtained from the subject's parent or guardian and assent from the child if ≥ 8 years of age. Aged ≥ 9 months to < 10 years In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results Subject had to be available for the study duration for the study duration, including all planned follow-up visits. Exclusion Criteria: A history of vaccination against, or infection with, JE or other flaviviruses (e.g. Kyanasur Forest Disease, West Nile virus, dengue fever). Previous JE vaccination was to be determined by history (interview of subject's parent or guardian) or by inspecting the child's official vaccination record. Demonstration of parasitemia on malaria blood smear at Screening. History of residence in or travel to a JE-endemic region of India or elsewhere in Asia (for periods of 4 weeks or more). hypersensitivity to thimerosal or gelatin Have received a transfusion of blood, blood products or serum globulin in the preceding 6 months, Have an immunodeficiency or neurological disorder, or take drugs that suppress the immune system, Have a history of severe reaction to other vaccines, Have a chronic condition requiring medication, Intend to travel out of the area during the study period, Have spent at least 4 weeks in a JE-endemic region, Plan to receive any other vaccination within the double-blind treatment period, or who have received a vaccination in the month preceding Screening, Exhibit signs of secondary or tertiary malnutrition, Are seropositive to human immunodeficiency virus (HIV), Hepatitis B or C, Have malaria infection, or who have a fever within 3 days before vaccination. Those with an acute fever, or with previously scheduled vaccinations, may be rescheduled. Consideration of the routine immunisation schedule should be made such that it is ensured that routine vaccinations due are either given before entry to the trial, or afterwards if delayed because of the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Dubey, M.D
Organizational Affiliation
Maulana Azad Medical College, New Delhi, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bakul B. Javadekar, M.D.
Organizational Affiliation
Government Medical College, Baroda, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Atul Shanker, Dr.
Organizational Affiliation
Dr Atul's Child Hospital, Jaipur, Rajasthan, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Atul's Child Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302016
Country
India
Facility Name
Government Medical College
City
Baroda
ZIP/Postal Code
390001
Country
India
Facility Name
Maulana Azad Medical College
City
New Delhi
ZIP/Postal Code
110002
Country
India

12. IPD Sharing Statement

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Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

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