Clinical Trial: Evaluating the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1 Evaluation of the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3

Brief Summary: This study will evaluate the ability of a single dose of the live attenuated recombinant tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005 vaccine.

Detailed Summary:

Dengue infection ranging from mild illness to life-threatening disease is widespread in most tropical and subtropical regions of the world. Infection with any of the four serotypes of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4) can cause dengue illness. TetraVax-DV-TV005 (referred to as TV005) is a live attenuated recombinant tetravalent dengue virus vaccine developed to protect against all four dengue virus serotypes. This study will evaluate the ability of a single dose of TV005 to protect against infection with rDEN3Δ30, a naturally attenuated DENV-3, given 6 months following vaccination with TV005.

This study will enroll healthy adults with no history of previous flavivirus infection. At Day 0 (study entry), participants will be randomly assigned to receive either the TV005 vaccine or placebo. On Day 180, all participants will receive the rDEN3Δ30 virus. All participants will record their temperature 3 times a day for 16 days after each vaccination. Additional study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 184, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. Study visits will include physical examinations and blood collection.


Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • Frequency of TV005 and rDEN3Δ30-related adverse events (AEs) [ Time Frame: Measured through Day 360 ]
    As classified by both severity and seriousness, through active and passive surveillance
  • Frequency of viremia [ Time Frame: Measured through Day 360 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: August 16, 2016
Date Started:
Date Completion: December 2017
Last Updated: September 15, 2016
Last Verified: September 2016