NCT00118924.

Trial name or 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"
Methods	Randomized controlled trial; Phase I study
Participants	Inclusion criteria: healthy adults aged 18 to 50 years; willingness to use contraception Exclusion criteria: pregnancy; clinically significant diseases; blood diseases; history of encephalitis, alcohol or drug use, allergic reaction or anaphylaxis; human immunodeficiency virus‐1 (HIV‐1) or hepatitis C infection; use of corticosteroids or immunosuppressive drugs; previously immunization with other vaccines; history of tick‐borne encephalitis (TBE) or dengue or flavivirus infection
Interventions	1. Live‐attenuated LGT(TP21)/DEN4 vaccine (103 or 105 PFU) 2. Placebo Schedule: 2 doses subcutaneously administered 6 months apart
Outcomes	1. Immunogenicity of vaccine against anti‐Langat neutralizing antibody (at days 0, 28, 42, and 180) 2. Frequency of vaccine‐related adverse effects, graded by intensity and severity through active and passive surveillance (throughout study)
Starting date	July 2005
Contact information	Principal Investigators: Anna Durbin, MD (Center for Immunization Research, Johns Hopkins School of Public Health); Peter Wright, MD (Vanderbilt University School of Medicine)
Notes	Location: Tennessee Vanderbilt University School of Medicine, Nashville, Tennessee, USA