NCT00319592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
12 months until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 28, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
6 years until next milestone

Results Posted

Study results publicly available

August 16, 2012

Completed
Last Updated

August 20, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

April 28, 2006

Results QC Date

July 11, 2012

Last Update Submit

August 16, 2012

Conditions

Japanese Encephalitis

Keywords

Japanese encephalitisChimeriVax™-JEJE-VAX®

Outcome Measures

Primary Outcomes (5)

  • 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.

    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).

    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. \[Seropositive status can be 'Yes' or 'No'\]

    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).

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

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

    Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.

    Day 0 up to Day 6 post-vaccination

Study Arms (2)

ChimeriVax™-JE

EXPERIMENTAL

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

Biological: ChimeriVax™-JE vaccine

JE-VAX®

ACTIVE COMPARATOR

Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.

Biological: JE-VAX® vaccine

Interventions

ChimeriVax™-JE vaccineBIOLOGICAL

0.5 mL, subcutaneously

Also known as: ChimeriVax™-JE
ChimeriVax™-JE
JE-VAX® vaccineBIOLOGICAL

1.0 mL, subcutaneously

Also known as: JE-VAX®
JE-VAX®

Eligibility Criteria

Age18 Years - 48 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharamacology Center

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Results Point of Contact

Title
Medical Director
Organization
Sanofi Pasteur Inc.
RegistryContactUs@sanofipasteur.com

Study Officials

  • Nancy L Abdou, MD

    PRA Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2006

First Posted

April 27, 2006

Study Start

May 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

August 20, 2012

Results First Posted

August 16, 2012

Record last verified: 2012-08

Locations

US(1)