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)

Dengue Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Dengue

Clinical Trial Details

NCT number	NCT02450838
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 1
Start date	April 2015
Completion date	October 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.