Safety of and Immune Response to a Tick-Borne Encephalitis Vaccine (LGT(TP21)/DEN4) in Healthy Adults
Tick-Borne Encephalitis
About this trial
This is an interventional prevention trial for Tick-Borne Encephalitis focused on measuring Dengue Vaccine, Tick-Borne Illnesses, Flavivirus
Eligibility Criteria
Inclusion Criteria: Willing and available to be followed for the duration of the study Willing to use acceptable means of contraception Good general health Exclusion Criteria: 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
Sites / Locations
- Vanderbilt University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
1
2
3
One subcutaneous vaccination with a 10^3 PFU dose of LGT(TP21)/DEN4 vaccine given in the deltoid region of either arm. A second booster vaccination will be given 6 months after the first vaccination.
One subcutaneous vaccination with a 10^5 PFU dose of LGT(TP21)/DEN4 vaccine given in the deltoid region of either arm. A second booster vaccination will be given 6 months after the first vaccination. This arm may enroll after Arm 1 depending on the immunological response of Arm 1.
One subcutaneous vaccination with a placebo vaccine given in the deltoid region of either arm. A second placebo vaccination will be given 6 months after the first vaccination.