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

Purpose

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.

Condition	Intervention	Phase
Japanese Encephalitis	Biological: ChimeriVax™-JE vaccine Biological: JE-VAX® vaccine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official 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®).

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 0 up to Day 56 post-vaccination ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 0 (Pre-vaccination) and up to Month 12 After First Dose ] [ Designated as safety issue: No ]
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® [ Time Frame: Day 0 (pre-vaccination) up to month 12 post-vaccination ] [ Designated as safety issue: No ]
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® [ Time Frame: Day 0 up to Day 6 post-vaccination ] [ Designated as safety issue: No ]
Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.

Enrollment:	60
Study Start Date:	May 2005
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ChimeriVax™-JE 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 0.5 mL, subcutaneously Other Name: ChimeriVax™-JE
Active Comparator: JE-VAX® Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.	Biological: JE-VAX® vaccine 1.0 mL, subcutaneously Other Name: JE-VAX®

Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319592

Locations

United States, Kansas
Clinical Pharamacology Center
Lenexa, Kansas, United States, 66219

Sponsors and Collaborators

Sanofi

PRA International

Investigators

Principal Investigator:

Nancy L Abdou, MD

PRA International

More Information

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00319592 History of Changes
Other Study ID Numbers:	H-040-008
Study First Received:	April 28, 2006
Results First Received:	July 11, 2012
Last Updated:	August 16, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi:

Japanese encephalitis
ChimeriVax™-JE
JE-VAX®

Additional relevant MeSH terms:

Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on June 18, 2013