Evaluation of the Safety and Immune Response of Five 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 of five 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 five versions of a live, attenuated,
      tetravalent dengue virus vaccine called TetraVax-DV.

      This study will enroll healthy adults 18-50 years old. Participants will be randomly assigned
      to receive one of the five versions of TetraVax-DV or placebo. At the vaccination study
      visit, participants will undergo a medical history review, physical examination, blood and
      urine collection, and vital sign measurements. Participants will then receive one 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. At home, participants
      will monitor and record their temperature three times a day for 16 days. Additional study
      visits will occur at Days 2, 4, 6, 8, 10, 12, 14, 16, 21, 28, 42, and 180 for physical exams,
      assessment of symptoms, and blood and urine collection. Some participants will attend an
      additional study visit at Day 60.

      Participants who received one of the five versions of the vaccine will be asked to take part
      in an optional substudy that will evaluate the safety and immunogenicity of a second
      vaccination 6 months after the first vaccination. In the substudy, participants will be
      randomly assigned to receive either the same vaccine they received in the first part of the
      study or a placebo vaccine. For 6 months following the second vaccination, participants will
      attend study visits and take part in the same study procedures that occurred in the first
      part of the study.
    

Intervention name(s): TetraVax-DV Vaccine-Admixture 1; TetraVax-DV Vaccine-Admixture 2; TetraVax-DV Vaccine-Admixture 3; TetraVax-DV Vaccine-Admixture 4; Placebo; TetraVax-DV Vaccine-Admixture 5
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 1 (10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3-3´D4Δ30, 10^3 PFU of rDEN4Δ30); One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 2 (10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3-3´D4Δ30, 10^3 PFU of rDEN4Δ30-200,201); One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 3 (10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, 10^3 PFU of rDEN4Δ30); One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 4 (10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, 10^3 PFU of rDEN4Δ30-200,201); One subcutaneous injection of a placebo containing vaccine diluent but no actual vaccine; One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 5 (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)
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