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

NCT00441259 | Completed Phase 2 Results DMC

• 1 other identifier: H-040-004
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

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.

Conditions

Japanese Encephalitis

Keywords

Japanese Encephalitis

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

  Day 14 up to Day 42 Post-vaccination

• Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

  Day 14 up to Day 42 Post-vaccination

• 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).

  Day 42 Post-vaccination

• 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).

  Day 42 Post Dose 1

Secondary Outcomes (2)

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

  Day 42 Post Dose 1

• Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine

  Day 42 Post-vaccination

Study Arms (2)

JE-CV Group

EXPERIMENTAL

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

Biological: ChimeriVax™-JE

MBDV Group

ACTIVE COMPARATOR

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

Biological: Japanese Encephalitis Inactivated Mouse Brain Vaccine

Interventions

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

JE-CV Group

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

MBDV Group

Eligibility Criteria

• Age: 9 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Dr Atul's Child Hospital

Jaipur, Rajasthan, 302016, India

Location

Government Medical College

Baroda, 390001, India

Location

Maulana Azad Medical College

New Delhi, 110002, India

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: February 28, 2007
• Study Start: January 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 27, 2012
• Results First Posted: August 27, 2012

Record last verified: 2012-07

Locations

IN (3)