Evaluating the Safety and Immune Response to Two Admixtures of a Tetravalent Dengue Virus Vaccine
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue viruses can cause dengue fever and other serious health conditions, primarily
      affecting people living in tropical regions of the world. This study will evaluate the safety
      and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy
      adults.
    

Detailed description: 
      Dengue viruses cause dengue fever and the more severe condition, dengue hemorrhagic
      fever/shock syndrome. Dengue viruses are common in most tropical and subtropical regions of
      the world and infection with dengue viruses is the leading cause of hospitalization and death
      in children in many tropical Asian countries. For these reasons, the World Health
      Organization (WHO) has made the development of a dengue virus vaccine a top priority. This
      study will evaluate the safety and immunogenicity of two doses of a live, attenuated,
      tetravalent dengue virus vaccine called TetraVax-DV in healthy adults. Two different versions
      of the TetraVax-DV vaccine will be evaluated.

      This study will enroll healthy adults 18-50 years old. Participants will be randomly assigned
      to receive one of two admixtures of the TetraVax-DV vaccine or a placebo. At a baseline study
      visit, participants will undergo a medical history review, physical examination, blood
      collection, vital sign measurements, and a pregnancy test for females. Participants will then
      receive one injection of their assigned vaccine in the upper arm. After receiving the
      vaccine, participants will remain in the clinic for 30 minutes for observation and
      monitoring. At home, participants will monitor and record their temperature three times a day
      for 16 days. Additional study visits will occur at Days 3, 8, 10, 12, 14, 16, 21, 28, 56, 90,
      and 150 and will include a physical examination, assessment of symptoms, and blood
      collection. On Day 180, participants will receive a second injection of the same vaccine they
      received at the baseline study visit. Follow-up study visits will occur at Days 183, 188,
      190, 192, 194, 196, 201, 208, 236, 270, and 360, and will include the same study procedures
      and monitoring that occurred after the first vaccination.
    

Intervention name(s): TetraVax-DV Vaccine - Admixture TV003; TetraVax-DV Vaccine - Admixture TV005; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant TetraVax-DV vaccine, Admixture TV003 (10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30(ME), 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30); One subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant TetraVax-DV vaccine, Admixture TV005 (10^3 PFU of rDEN1Δ30, 10^4 PFU of rDEN2/4Δ30(ME), 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30); One subcutaneous injection at Day 0 and Day 180 of placebo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Virus; Dengue Fever; Dengue Vaccine; Dengue Hemorrhagic Fever; Dengue Shock Syndrome