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

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Brief Title

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

Official Title

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

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.
    

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 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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Frequency of vaccine-related adverse effects, graded by intensity and severity through active and passive surveillance

Secondary Outcome

 Recovery of virus from the blood of a vaccinee or seroconversion

Condition

Tick-Borne Encephalitis

Intervention

LGT(TP21)/DEN4

Study Arms / Comparison Groups

 1
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

28

Start Date

July 2005

Completion Date

July 2007

Primary Completion Date

July 2007

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
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Anna Durbin, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00118924

Organization ID

CIR 182

Secondary IDs

H.22.03.09.26.B2


Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

 Johns Hopkins Bloomberg School of Public Health

Study Sponsor

Anna Durbin, MD, Principal Investigator, Center for Immunization Research, Johns Hopkins School of Public Health


Verification Date

January 2008