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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)

NCT02450838 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-04-04

No results posted yet for this study

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).

Conditions

  • Dengue

Interventions

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

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Anna Durbin, MD · Center for Immunization Research (CIR), Johns Hopkins School of Public Health

  • Kristen Pierce, MD · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02450838 on ClinicalTrials.gov