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

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins Bloomberg School of Public Health
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00118924
First received: July 8, 2005
Last updated: January 18, 2008
Last verified: January 2008

July 8, 2005
January 18, 2008
July 2005
July 2007   (final data collection date for primary outcome measure)
  • Frequency of vaccine-related adverse effects, graded by intensity and severity through active and passive surveillance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Immunogenicity of vaccine against anti-Langat neutralizing antibody [ Time Frame: At Days 0, 28, 42, and 180 ] [ Designated as safety issue: No ]
  • Frequency of vaccine-related adverse effects, graded by intensity and severity through active and passive surveillance
  • immunogenicity of vaccine against anti-Langat neutralizing antibody on Days 0, 28, 42, and 180
Complete list of historical versions of study NCT00118924 on ClinicalTrials.gov Archive Site
  • Recovery of virus from the blood of a vaccinee or seroconversion [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Immunogenicity of the LGT(TP21)/DEN4 vaccine against other TBE viruses [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Durability of antibody responses to Langat and other TBE viruses [ Time Frame: At Day 180 ] [ Designated as safety issue: No ]
  • Recovery of virus from the blood of a vaccinee or seroconversion
  • immunogenicity of the LGT(TP21)/DEN4 vaccine against other TBE viruses
  • durability of antibody responses to Langat and other TBE viruses at 6 months (180 days)
Not Provided
Not Provided
 
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

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.

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 immunogenicity of a live attenuated chimeric virus, LGT(TP21)/DEN4, which is derived from the Langat flavivirus and DEN4 dengue virus serotypes.

Each volunteer will be involved in the study for 180 days. Participants in Cohort 1 will be randomly assigned to receive LGT(TP21)/DEN4 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of LGT(TP21)/DEN4 or placebo.

After vaccination, participants will be asked to monitor their temperatures every day for 16 days and on Day 19. Study visits will occur every other day after vaccination until Day 16, followed by 5 additional visits at selected days through Day 180. Blood collection and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Tick-Borne Encephalitis
  • Biological: LGT(TP21)/DEN4
    Live attenuated LGT(TP21)/DEN4 vaccine (one of two doses)
  • Biological: Placebo
    Placebo for LGT(TP21)/DEN4 vaccine
  • Experimental: 1
    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.
    Intervention: Biological: LGT(TP21)/DEN4
  • Experimental: 2
    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.
    Intervention: Biological: LGT(TP21)/DEN4
  • Placebo Comparator: 3
    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.
    Intervention: Biological: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00118924
CIR 182, H.22.03.09.26.B2
Yes
Anna Durbin, MD, Center for Immunization Research, Johns Hopkins School of Public Health
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins Bloomberg School of Public Health
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
National Institute of Allergy and Infectious Diseases (NIAID)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP