Safety Study of a Vaccine (DENV-1 PIV) to Prevent Dengue Disease

Completed · Phase 1

Conditions studied: Dengue Fever

In brief

This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever.

Key facts

Study ID

NCT01502735

Run by

U.S. Army Medical Research and Development Command

People needed

20

Starts

2011-12-01

Expected to finish

2013-09-01

Last updated by the study team

2015-04-22

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females 18 years of age or the legal age of consent (whichever is greater) to 50 (inclusive) years of age
• Negative screening laboratory test against dengue, Japanese Encephalitis, West Nile, and Yellow Fever viruses
• Healthy
• All subjects must agree to use contraception or to abstain from sex from enrollment through trial completion
• Able to provide informed consent and able to be followed throughout the trial period

You may not qualify if…

• History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, West Nile virus, Yellow fever, and dengue
• Have a known or suspected hypersensitivity or adverse reaction to vaccines
• Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0
• Are pregnant or breastfeeding
• Known HIV, Hepatitis B and/or Hepatitis C infection
• Have any acute illness, including an oral body temperature greater than 100.4°F at the day of vaccination
• Have any occupational, social, or medical concerns that would impact subject safety, interfere with protocol adherence, or affect a subject's ability to give informed consent
• Have been using immunomodulatory therapy (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) within the past 6 months; medications or nutritional supplements known to or which potentially could affect organ function within 30 days prior to the initial injection
• Have received an investigational drug or vaccine or participated in a drug product or vaccine study within a period of 30 days prior to Day 0
• Have received or donated blood or plasma within 90 days of Day 0 (or plan on receiving or donating blood or plasma during the study)

Where it is running

• WRAIR, Clinical Trials Center (CTC) — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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