NCT02317900

Evaluation of the Safety and Efficacy of a Single Dose of a Dengue Vaccine (TV005) in Healthy Adults

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 Attenuated DENV-2, rDEN2∆30-7169

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Dengue viruses are widespread in most tropical and subtropical regions of the world. This study will evaluate the safety and protective efficacy of a dengue vaccine (called TV005) against viremia and rash induced by a DENV-2 vaccine virus (called rDEN2∆30-7169) in healthy adults.

Detailed description

There are four types of dengue viruses (DENV-1, DENV-2, DENV-3, and DENV-4), each of which can cause mild to life-threatening illness. This study will evaluate the protective efficacy of TV005 (a dengue virus vaccine) administered at Day 0 against viremia and rash induced by rDEN2∆30-7169 (a live attenuated candidate DENV-2 vaccine) administered at Day 180. The safety and immunogenicity of the TV005 and rDEN2∆30-7169 vaccines will also be evaluated. This study will enroll healthy adults with no history of previous infection with a dengue virus or a flavivirus. Participants will be randomly assigned to receive a single injection of TV005 or placebo at study entry (Day 0). All participants will receive a single injection of rDEN2∆30-7169 on Day 180. For at least 30 minutes after each vaccination, participants will remain in the study clinic to be monitored for any adverse effects of the vaccines. Participants will record their temperature three times a day for 16 days after the first and second vaccinations. In addition to study visits at Day 0 and 180, participants will attend study visits at Day 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. At select study visits, participants will undergo a physical examination, medical history review, blood collection, and a pregnancy test for female participants.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	TV005	TV005 is a live attenuated recombinant tetravalent dengue virus vaccine. It will be administered as a 0.5 mL dose containing 10\^3 plaque forming units (PFUs) of each component (10\^3.3 PFUs/mL of rDEN1∆30, 10\^4.3 PFU/mL of rDEN2/4∆30(ME), 10\^3.3 PFU/mL of rDEN3∆30/31-7164 and 10\^3.3 PFU/mL of rDEN4∆30). It will be delivered by subcutaneous injection in the deltoid region of the upper arm.
BIOLOGICAL	Placebo	The placebo vaccine will be administered as a 0.5 mL dose delivered by subcutaneous injection in the deltoid region of the upper arm.
BIOLOGICAL	rDEN2∆30-7169	rDEN2∆30-7169 is a live recombinant attenuated DENV-2 candidate vaccine virus. It will be administered as a 0.5 mL dose containing 10\^3 PFUs of rDEN2∆30-7169. It will be delivered by subcutaneous injection in the deltoid region of the upper arm.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-11-01
• First posted: 2014-12-17
• Last updated: 2017-02-01

Locations

2 sites across 1 country: United States