Clinical Trial: Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Evaluation of the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2

Brief Summary: Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority. This study will evaluate the ability of a single dose of a trivalent dengue vaccine to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6 months after the trivalent dengue vaccine.

Detailed Summary:

There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each capable of causing dengue illness ranging from a mild illness to life-threatening disease. This study will evaluate a trivalent live attenuated dengue admixture vaccine that contains 3 different monovalent dengue vaccine candidates, representing 3 of the 4 dengue serotypes (DENV-1, DENV-3, and DENV-4). Study researchers will evaluate the safety and protective efficacy of a single dose of the trivalent dengue vaccine against viremia and rash induced by infection with an attenuated DENV-2 virus (rDEN2Δ30-7169), administered 6 months after the trivalent dengue vaccine.

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 trivalent dengue vaccine admixture or placebo. On Day 180, all participants will receive the rDEN2Δ30-7169 vaccine. Study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 180, 184, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. Visits will include physical examinations and blood collection. All participants will record their temperature 3 times a day for 16 days after each vaccination.


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

Current Primary Outcome:

  • Frequency of trivalent dengue vaccine admixture and rDEN2Δ30-7169-related adverse events (AEs) [ Time Frame: Measured through Day 360 ]
    Classified by both severity and seriousness, through active and passive surveillance.
  • Dengue virus neutralizing antibody titers (measured through blood collection) [ 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: April 27, 2015
Date Started: September 2015
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017