NCT02433652

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant live attenuated trivalent dengue vaccine	Contains 10\^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10\^3.3 PFU/mL of rDEN3Δ30/31-7164 and 10\^3.3 PFU/mL of rDEN4Δ30. It is administered in 0.5 mL containing 10\^3.0 PFU of each component.
BIOLOGICAL	Placebo
BIOLOGICAL	rDEN2Δ30-7169 vaccine	Live recombinant attenuated DENV-2 candidate vaccine virus; will be administered at a dose of 10\^3 PFU

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-11-01
• First posted: 2015-05-05
• Last updated: 2018-02-28

Locations

2 sites across 1 country: United States