A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX

Phase 2CompletedNCT00319592

Sanofi60 enrolled

Overview

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Japanese Encephalitis

Interventions

ChimeriVax™-JE vaccineBIOLOGICAL

0.5 mL, subcutaneously

JE-VAX® vaccineBIOLOGICAL

1.0 mL, subcutaneously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 48 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent obtained. * Aged ≥18 to \<49 years. * In good general health. * Available for the study duration, including all planned follow-up visits. * Females must have negative pregnancy test and be using adequate form of contraception Exclusion Criteria: * Clinically significant abnormalities on laboratory and vital sign assessments. * Anaphylaxis or other serious adverse reactions * Administration of another vaccine within 30 days of study treatment period. * Physical examination indicating any significant medical condition. * Intention to travel out of the area prior to the study visit on Day 56. * Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen. * Pregnancy. * Excessive alcohol consumption, drug abuse. * Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.

Locations (1)

Clinical Pharamacology Center

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of \< 1:10.

Time frame: Day 0 (pre-vaccination) and up to Day 56 post-vaccination

Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).

Time frame: Day 0 up to Day 56 post-vaccination

Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. \[Seropositive status can be 'Yes' or 'No'\]

Time frame: Day 0 (Pre-vaccination) and up to Month 12 After First Dose

Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®

Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).

Time frame: Day 0 (pre-vaccination) up to month 12 post-vaccination

Data from ClinicalTrials.gov

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