Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-07 @ 11:30 AM
Study NCT ID:
NCT02873260
Status:
COMPLETED
Last Update Posted:
2018-03-08
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
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 rDEN3Δ30
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: