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

Japanese Encephalitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441259
• Other study ID #: H-040-004
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2007
• Last updated: July 24, 2012
• Start date: January 2007
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 10 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

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
• 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

Locations

Country	Name	City	State
India	Government Medical College	Baroda
India	Dr Atul's Child Hospital	Jaipur	Rajasthan
India	Maulana Azad Medical College	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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 Dose 1	No
Secondary	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).	Day 42 Post-vaccination	No