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Completed

NCT Number: NCT00314145

A Safety and Efficacy Study 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Adelaide, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ChimeriVax™-JE

Biological

0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)

JE-VAX®

Biological

0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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®)

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 13, 2006
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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