Safety of and Immune Response to a Tick-Borne Encephalitis Vaccine (LGT(TP21)/DEN4) in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Tick-Borne Encephalitis

In brief

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 study is to test the safety of and immune response to a TBE vaccine in healthy adults. The vaccine is related to a live attenuated virus developed against dengue virus infection.

Key facts

Study ID

NCT00118924

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

28

Starts

2005-07-01

Expected to finish

2007-07-01

Last updated by the study team

2008-01-21

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Willing and available to be followed for the duration of the study
• Willing to use acceptable means of contraception
• Good general health

You may not qualify if…

• 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

Where it is running

• Vanderbilt University School of Medicine — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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