Safety of and Immune Response to a Tick-Borne Encephalitis Vaccine (LGT(TP21)/DEN4) in Healthy Adults
Phase 1 Study of the Safety and Immunogenicity of Tick-Borne Langat/Dengue 4 Chimera (LGT(TP21)/DEN4), a Live Attenuated Vaccine for Tick-Borne Encephalitis
2 other identifiers
interventional
28
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 8, 2005
CompletedFirst Posted
Study publicly available on registry
July 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJanuary 21, 2008
January 1, 2008
2 years
July 8, 2005
January 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Frequency of vaccine-related adverse effects, graded by intensity and severity through active and passive surveillance
Throughout study
Immunogenicity of vaccine against anti-Langat neutralizing antibody
At Days 0, 28, 42, and 180
Secondary Outcomes (3)
Recovery of virus from the blood of a vaccinee or seroconversion
Throughout study
Immunogenicity of the LGT(TP21)/DEN4 vaccine against other TBE viruses
Throughout study
Durability of antibody responses to Langat and other TBE viruses
At Day 180
Study Arms (3)
1
EXPERIMENTALOne 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.
2
EXPERIMENTALOne 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.
3
PLACEBO COMPARATOROne 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.
Interventions
Eligibility Criteria
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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232-2581, United States
Related Publications (4)
Beran J. Immunisation against tick-borne encephalitis by widely used vaccines: short-term history and current recommendations. Clin Microbiol Infect. 2005 May;11(5):424-6. doi: 10.1111/j.1469-0691.2005.01115.x. No abstract available.
PMID: 15819877BACKGROUNDChang GJ, Kuno G, Purdy DE, Davis BS. Recent advancement in flavivirus vaccine development. Expert Rev Vaccines. 2004 Apr;3(2):199-220. doi: 10.1586/14760584.3.2.199.
PMID: 15056045BACKGROUNDLai CJ, Monath TP. Chimeric flaviviruses: novel vaccines against dengue fever, tick-borne encephalitis, and Japanese encephalitis. Adv Virus Res. 2003;61:469-509. doi: 10.1016/s0065-3527(03)61013-4.
PMID: 14714441BACKGROUNDPletnev AG, Bray M, Hanley KA, Speicher J, Elkins R. Tick-borne Langat/mosquito-borne dengue flavivirus chimera, a candidate live attenuated vaccine for protection against disease caused by members of the tick-borne encephalitis virus complex: evaluation in rhesus monkeys and in mosquitoes. J Virol. 2001 Sep;75(17):8259-67. doi: 10.1128/jvi.75.17.8259-8267.2001.
PMID: 11483771BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Durbin, MD
Center for Immunization Research, Johns Hopkins School of Public Health
- PRINCIPAL INVESTIGATOR
Peter Wright, MD
Vanderbilt University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 8, 2005
First Posted
July 12, 2005
Study Start
July 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
January 21, 2008
Record last verified: 2008-01