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Completed

NCT Number: NCT00441259

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

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.

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Key information

Conditions

Japanese Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Japanese Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

9 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr Atul's Child Hospital, Jaipur, Rajasthan, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ChimeriVax™-JE

Biological

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

Japanese Encephalitis Inactivated Mouse Brain Vaccine

Biological

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 outcomes

  1. 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

  2. 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

  3. Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

    Time frame: Day 42 Post-vaccination

    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).

  4. 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

    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 outcomes

  1. 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

    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).

  2. 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

    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).

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2007
Registry last updated
Aug 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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