Status:
COMPLETED
Safety of and Immune Response to a Tick-Borne Encephalitis Vaccine (LGT(TP21)/DEN4) in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
Conditions:
Tick-Borne Encephalitis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Tick-borne encephalitis (TBE) is a viral illness common in the Northern Hemisphere, especially Europe and Asia. TBE infection may lead to central nervous system problems and death. The purpose of this...
Detailed Description
TBE is a common illness in Europe and Asia, where it is usually associated with mild illness but sometimes leads to long-term symptoms and even death. This study will evaluate the safety and immunogen...
Eligibility Criteria
Inclusion
- Willing and available to be followed for the duration of the study
- Willing to use acceptable means of contraception
- Good general health
Exclusion
- Pregnancy or breastfeeding
- Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
- Blood disease
- History of migraine headaches
- History of encephalitis
- Alcohol or drug use that has caused medical, occupational, or family problems within 12 months prior to study entry
- History of severe allergic reaction or anaphylaxis
- Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry
- HIV-1 infected
- Hepatitis C virus infected
- Hepatitis B surface antigen positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
- Live vaccine within 4 weeks prior to study entry
- Killed vaccine within 2 weeks prior to study entry
- Blood products within 6 months prior to study entry
- Investigational drug or vaccine within 3 months prior to study entry
- Previously received a licensed or experimental yellow fever, tick-borne encephalitis, or dengue vaccine
- Surgical removal of spleen
- History of tick-borne encephalitis
- History of dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus, Japanese encephalitis virus)
- Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00118924
Start Date
July 1 2005
End Date
July 1 2007
Last Update
January 21 2008
Active Locations (1)
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1
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232-2581