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

Phase 2

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: ChimeriVax™-JE vaccine; Biological: JE-VAX® vaccine

• Registration Number: NCT00319592
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Posted: 2006-04-27
• Study First Submitted: 2006-04-28
• Study First Submitted QC: 2006-04-28
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Results First Submitted: 2012-07-11
• Results First Submitted QC: 2012-07-11
• Status Verified: 2012-08
• Results First Posted: 2012-08-16
• Last Update Submitted: 2012-08-16
• Last Update Posted: 2012-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ChimeriVax™-JE	ChimeriVax™-JE vaccine	Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
JE-VAX®	JE-VAX® vaccine	Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.

Primary Outcome Measures

Name	Time	Method
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	Day 0 (pre-vaccination) and up to Day 56 post-vaccination	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.
Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE	Day 0 up to Day 56 post-vaccination	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).
Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.	Day 0 (Pre-vaccination) and up to Month 12 After First Dose	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. \[Seropositive status can be 'Yes' or 'No'\]
Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®	Day 0 (pre-vaccination) up to month 12 post-vaccination	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).
Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®	Day 0 up to Day 6 post-vaccination	Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.

Trial Locations

Locations (1)

Clinical Pharamacology Center; 🇺🇸 Lenexa, Kansas, United States