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

NCT00118924 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2008-01-21

No results posted yet for this study

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.

Conditions

  • Tick-Borne Encephalitis

Interventions

BIOLOGICAL

LGT(TP21)/DEN4

Live attenuated LGT(TP21)/DEN4 vaccine (one of two doses)

BIOLOGICAL

Placebo

Placebo for LGT(TP21)/DEN4 vaccine

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Anna Durbin, MD · Center for Immunization Research, Johns Hopkins School of Public Health

  • Peter Wright, MD · Vanderbilt University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00118924 on ClinicalTrials.gov