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Completed

NCT Number: NCT00319592

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

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.

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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–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Pharamacology Center

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

ChimeriVax™-JE vaccine

Biological

0.5 mL, subcutaneously

Other names: ChimeriVax™-JE

JE-VAX® vaccine

Biological

1.0 mL, subcutaneously

Other names: JE-VAX®

Primary outcomes

  1. 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

    Time frame: 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.

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

    Time frame: 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).

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

    Time frame: 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']

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

    Time frame: 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).

  5. Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • PRA Health Sciences

Registry information

Official study title

Randomized, Double-blind, Phase II Study of the Safety, Tolerability and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™ JE) Compared With Mouse Brain-derived Inactivated JE Vaccine (JE VAX®).

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 27, 2006
Registry last updated
Aug 20, 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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