Clinical trial NCT00314132: Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
Official title: Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Encephalitis
Japanese Encephalitis
Keywords: Japanese Encephalitis
Encephalitis virus
ChimeriVax™-JE Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-13
Enrollment: 2004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained from the subject.
* Aged 18 years or above at screening.
* In good general health
* Subject available for the study duration
* For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.

Exclusion Criteria:

* A history of vaccination against or infection with JE.
* Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.
* History of thymoma, thymic surgery (removal) or myasthenia gravis.
* Clinically significant abnormalities on laboratory assessment
* Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).
* Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30.
* Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30.
* Physical examination indicating any clinically significant medical condition.
* Oral temperature \>38°C (100.4°F) or acute illness within 3 days prior to inoculation.
* Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30.
* Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.
* Lactation or intended pregnancy in female subjects.
* Excessive alcohol consumption, drug abuse, significant psychiatric illness.
* A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).
* Participation in another clinical study within 30 days of the screening visit for this study.
* Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study.
* Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study.

Primary outcomes:
measure: Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
timeFrame: Day 0 up to 30 days post-vaccination
measure: Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
timeFrame: Day 0 up to 30 days post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Burbank
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Davis
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Vallejo
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Iowa City
country: United States
state: Iowa
city: Overland Park
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Livonia
country: United States
state: Michigan
city: Sprnigfield
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Winston Salem
country: United States
state: North Carolina
city: Fort Worth
country: United States
state: Texas
city: Darlinghurst
country: Australia
city: Enoggera
country: Australia
city: Heidelbeg West
country: Australia
city: Kippa-Ring
country: Australia
city: Mill Park
country: Australia
city: Toorak Gardens
country: Australia
Study officials:
affiliation: Vince and Associates Clinical Research
name: Steven G Hull, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.