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

Japanese Encephalitis Clinical Trial

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®).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319592
• Other study ID #: H-040-008
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2006
• Last updated: August 16, 2012
• Start date: May 2005
• Est. completion date: September 2006

Study information

• Verified date: August 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 48 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• ChimeriVax™-JE vaccine
0.5 mL, subcutaneously
• JE-VAX® vaccine
1.0 mL, subcutaneously

Locations

Country	Name	City	State
United States	Clinical Pharamacology Center	Lenexa	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	PRA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No