Clinical Trial: TDENV PIV and LAV Dengue Prime-boost Strategy

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

Official Title: A Phase 1, Randomized, Open-label, Single-center, Study of TDENV-PIV and LAV Dengue Vaccine Platforms as Part of a Heterologous Prime-boost Strategy in Healthy Adults in a

Brief Summary: The potential synergistic effect of administering 2 dengue vaccine candidates that were previously shown to be safe and immunogenic in humans will be evaluated in this study. A prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with alum and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17) will gather data to help better understand the human immune response to dengue vaccination and infection.

Detailed Summary:
Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome:

  • Number of solicited adverse events [ Time Frame: 21 days after each vaccination ]
  • Number of unsolicited adverse events [ Time Frame: 28 days after each vaccination ]
  • Number of hematological and biochemistry abnormalities [ Time Frame: 7 and 28 days and each vaccination ]
  • Number of serious adverse events [ Time Frame: Day 208 or day 360 ]
  • Number of potential immune-mediated diseases [ Time Frame: Day 208 or day 360 ]
  • Number of medically attended adverse events [ Time Frame: Day 208 or day 360 ]


Original Primary Outcome:

  • Number of solicited adverse events [ Time Frame: 7 days after each vaccination ]
  • Number of unsolicited adverse events [ Time Frame: 28 days after each vaccination ]
  • Number of hematological and biochemistry abnormalities [ Time Frame: 7 and 28 days and each vaccination ]
  • Number of serious adverse events [ Time Frame: Day 208 or day 360 ]
  • Number of potential immune-mediated diseases [ Time Frame: Day 208 or day 360 ]
  • Number of medically attended adverse events [ Time Frame: Day 208 or day 360 ]


Current Secondary Outcome: Microneutralizing (MN) dengue antibody titers [ Time Frame: Up to 1 year ]

Original Secondary Outcome:

Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: September 10, 2014
Date Started: November 2014
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017