This study will evaluate the safety and immunogenicity of a tetravalent dengue vaccine TetraVax-DV TV005 in adults 50 to 70 years of age with no history of previous flavivirus infection.
Dengue viruses (DENV) are widespread in most tropical and subtropical regions of the world. There are four serotypes of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4); each can cause dengue infection. Infection with dengue viruses can range from mild illness to life-threatening disease. TetraVax-DV TV005 (also referred to as TV005) is a live attenuated recombinant tetravalent dengue virus vaccine developed to protect against all four dengue virus serotypes. The purpose of this study is to evaluate the safety and immunogenicity of TV005 in adults 50 to 70 years of age with no history of previous flavivirus infection. Participants will be randomly assigned to receive a subcutaneous injection of either TV005 or placebo at study entry (Day 0). After receiving the injection, participants will record their temperature 3 times a day through Day 16. Additional study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 180. Visits will include a physical examination and blood collection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
28
Contains 10\^3 plaque-forming units (PFUs) of rDEN1Δ30, 10\^4 PFUs of rDEN2/4Δ30(ME), 10\^3 PFUs of rDEN3Δ30/31-7164, and 10\^3 PFUs of rDEN4Δ30; administered by subcutaneous injection in the deltoid region of the upper arm
Administered by subcutaneous injection in the deltoid region of the upper arm
Center for Immunization Research, Johns Hopkins School of Public Health
Baltimore, Maryland, United States
Frequency of TV005-related adverse events (AEs)
AEs classified by both severity and seriousness, through active and passive surveillance
Time frame: Measured through Day 180
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