Evaluating the Safety and Effectiveness of a Dengue Virus Vaccine in Healthy Adults
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue viruses can cause dengue illness ranging from a mild illness to life-threatening
      disease. The purpose of this study is to evaluate the protective effectiveness of a dengue
      virus vaccine in healthy adults.
    

Detailed description: 
      There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4); each can cause dengue
      illness ranging from a mild illness to life-threatening disease. More than 2 billion persons
      in tropical and subtropical regions of the world are at risk for acquiring dengue, which is
      why development of a dengue vaccine is a top public health priority.

      The purpose of this study is to evaluate the ability of a single dose of TetraVax-DV-TV003
      (TV003) vaccine to protect against infection with rDEN2∆30, an attenuated candidate DENV-2
      vaccine.

      This study will enroll healthy adults with no history of previous infection with a flavivirus
      (any of a group of viruses that includes the dengue virus). Participants will be randomly
      assigned to receive either the TV003 vaccine or placebo vaccine on Day 0 (study entry). At
      Day 180, all participants will receive an injection of the "challenge" virus, rDEN2∆30, an
      attenuated (weakened) DENV-2 vaccine. For at least 30 minutes after each vaccination,
      participants will remain in the study clinic to be monitored for any adverse effects of the
      vaccines. Participants will record their temperature at least 3 times a day for 16 days after
      the first and second vaccinations.

      In addition to vaccination visits at Day 0 and Day 180, participants will attend study visits
      at Day 2, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 182, 184, 186, 188, 190, 192, 194,
      196, 201, 208, 236, 270, and 360. At all study visits, participants will give a medical
      history and undergo a blood collection; at most study visits, participants will undergo a
      physical examination. Female participants will have a pregnancy test at select study visits.
    

Intervention name(s): TetraVax-DV-TV003; rDEN2∆30-7169; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): TetraVax-DV-TV003 is a live attenuated recombinant tetravalent dengue virus vaccine, which will be administered as a 0.5 mL dose containing 10^3.0 plaque forming units (PFUs) each of DENV-1, DENV-2, DENV-3, and DENV-4. It will be delivered by subcutaneous injection in the deltoid region of the upper arm.; The challenge virus, rDEN2∆30-7169, is a live recombinant attenuated DENV-2 candidate vaccine virus and will be administered as a 0.5 mL dose containing 10^3 PFUs of rDEN2∆30-7169. It will be delivered by subcutaneous injection in the deltoid region of the upper arm.; The placebo vaccine is the vaccine diluent 1X L-15, which will be administered as a 0.5 mL dose delivered by subcutaneous injection in the deltoid region of the upper arm.
Other intervention name(s): TV003
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention