NCT02450838

Evaluating the Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005)

A Phase I Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Tetravalent Recombinant Subunit Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Dengue viruses are mosquito-borne flaviviruses. Each year, dengue viruses infect millions of people throughout the tropics and subtropics. This study will evaluate the safety, tolerability, and immunogenicity of a tetravalent recombinant subunit dengue vaccine (V180) in healthy adults who previously received a live-attenuated tetravalent dengue vaccine (TV003 or TV005).

Detailed description

Dengue fever is caused by any one of four viral serotypes (DENV1, DENV2, DENV3, and DENV4) and infection by any serotype creates life-long immunity against that serotype. V180 is an experimental tetravalent recombinant subunit dengue vaccine that would protect against all four serotypes (DENV1, DENV2, DENV3, and DENV4). The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of adjuvanted (with Alhydrogel™) and nonadjuvanted formulations of V180 in healthy adults who have previously received the live-attenuated tetravalent dengue vaccine TV003 or TV005. Participants will be randomly assigned to receive one intramuscular injection of either adjuvanted V180, nonadjuvanted V180, or placebo at study entry (Day 1). Participants will record their temperature and any adverse events for 14 days after receiving the vaccination. Additional study visits will occur on Days 15, 28 and 180. Visits will include a physical examination and blood and urine collection. Study staff will contact participants by telephone at Days 7 and 90 (and at other occasional time points between Days 90 and 180) for health and safety follow-up monitoring.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	V180	Tetravalent recombinant subunit dengue vaccine; V180 will contain 10 µg, 10 µg, 10 µg, and 20 µg of the DENV1, DENV2, DENV3, and DENV4 antigens, respectively.
BIOLOGICAL	Alhydrogel™	Aluminum hydroxide gel adjuvant
BIOLOGICAL	Placebo

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-05-21
• Last updated: 2016-04-04

Locations

3 sites across 1 country: United States