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

December 4, 2012 updated by: Sanofi

A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

820

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • Melbourne, Australia
      • New South Wales, Australia
      • Queensland, Australia
      • Victoria, Australia
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60610
    • Kansas
      • Shawnee Mission, Kansas, United States, 66216
    • Montana
      • Missoula, Montana, United States, 59802
    • Texas
      • Dallas, Texas, United States, 75231
    • Washington
      • Tacoma, Washington, United States, 98403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects aged 18 or above
  • Subjects in good general health.
  • Females must have negative pregnancy test and be using adequate form of contraception

Exclusion Criteria:

  • History of vaccination/infection with JE or Yellow fever or other flaviviruses
  • History of residence/travel to flavivirus endemic regions
  • History of anaphylaxis/serious adverse reactions
  • Administration of vaccine within 30 days of study or during treatment period
  • Clinically significant physical exam/medical history/lab abnormalities
  • Pregnancy
  • Excessive alcohol/drug abuse
  • Hypersensitivity to constituents of JE-VAX®
  • Blood transfusion/treatment with blood product within 6months of study and during study treatment period
  • Known/suspected immunodeficiency
  • Compromised blood brain barrier
  • Employees of Clinical Research Organization (CRO)/study site staff
  • Any other condition which would exclude subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ChimeriVax™-JE
Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms.
Biological: ChimeriVax™-JE
0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)
ACTIVE_COMPARATOR: JE-VAX®
Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30.
Biological: JE-VAX®
0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Time Frame: Up to Day 60 post-first vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Up to Day 60 post-first vaccination
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Time Frame: Day 0 (Pre-vaccination) up to 60 days post-first vaccination

Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.

Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.
Day 0 (Pre-vaccination) up to 60 days post-first vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Time Frame: Up to Day 60 post-first vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Up to Day 60 post-first vaccination
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Time Frame: Day 60 post-first vaccination
Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Day 60 post-first vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: Luis Angles, M.D., Heart of America Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 12, 2006

First Posted (ESTIMATE)

April 13, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-040-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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