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 who have previously been infected with a dengue virus or other flavivirus or have
      previously received a flavivirus vaccine.
    

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 (18-50 years old) who
      have previously been infected with a dengue virus or other flavivirus or have previously
      received a flavivirus vaccine. Two different formulations of the TetraVax-DV vaccine will be
      evaluated.

      Participants will be randomly assigned to receive one of two admixtures of the TetraVax-DV
      vaccine or a placebo. At a baseline study visit (Day 0), 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 subcutaneous (SC) injection of
      their assigned vaccine or placebo 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 after
      the first vaccination (from Day 0 through Day 16) and for 16 days after the second
      vaccination (from Day 180 through Day 196). 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, vital sign
      measurements, and blood collection. On Day 180, participants will receive a second SC
      injection of their assigned vaccine or placebo. Additional study visits will then 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 SC injection at Day 0 and Day 180 of the TetraVax-DV Vaccine, Admixture TV003 (10^3 plaque-forming unit [PFU] of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30); One SC injection at Day 0 and Day 180 of the 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 SC 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