Clinical trial NCT00319592: A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
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®).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Japanese Encephalitis
Keywords: Japanese encephalitis
ChimeriVax™-JE
JE-VAX®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2006-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Day 0 (pre-vaccination) and up to Day 56 post-vaccination
measure: Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
timeFrame: Day 0 up to Day 56 post-vaccination
measure: Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.
timeFrame: Day 0 (Pre-vaccination) and up to Month 12 After First Dose
measure: Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®
timeFrame: Day 0 (pre-vaccination) up to month 12 post-vaccination
measure: Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
timeFrame: Day 0 up to Day 6 post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Clinical Pharamacology Center
state: Kansas
Study officials:
affiliation: PRA Health Sciences
name: Nancy L Abdou, MD
role: PRINCIPAL_INVESTIGATOR
References: