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

Purpose

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.

Condition	Intervention	Phase
Japanese Encephalitis	Biological: ChimeriVax™-JE Biological: Japanese Encephalitis Inactivated Mouse Brain Vaccine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine [ Time Frame: Day 42 Post-vaccination ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 42 Post Dose 1 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 42 Post Dose 1 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 42 Post-vaccination ] [ Designated as safety issue: No ]
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).

Enrollment:	96
Study Start Date:	January 2007
Study Completion Date:	December 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: JE-CV Group Participants will receive Japanese encephalitis chimeric virus vaccine (JE-CV)	Biological: ChimeriVax™-JE 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
Active Comparator: MBDV Group Participants will receive the mouse brain-derived vaccine (MBDV)	Biological: Japanese Encephalitis Inactivated Mouse Brain Vaccine 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

Eligibility

Ages Eligible for Study:	9 Months to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441259

Locations

India
Dr Atul's Child Hospital
Jaipur, Rajasthan, India, 302016
Government Medical College
Baroda, India, 390001
Maulana Azad Medical College
New Delhi, India, 110002

Sponsors and Collaborators

Sanofi

Investigators

Principal Investigator:	Anand Dubey, M.D	Maulana Azad Medical College, New Delhi, India
Principal Investigator:	Bakul B. Javadekar, M.D.	Government Medical College, Baroda, India
Principal Investigator:	Atul Shanker, Dr.	Dr Atul's Child Hospital, Jaipur, Rajasthan, India

More Information

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00441259 History of Changes
Other Study ID Numbers:	H-040-004
Study First Received:	February 27, 2007
Results First Received:	June 6, 2012
Last Updated:	July 24, 2012
Health Authority:	United States: Food and Drug Administration India: Drugs Controller General of India

Keywords provided by Sanofi:

Japanese Encephalitis

Additional relevant MeSH terms:

Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 16, 2013