Status:
COMPLETED
Safety Study of a Vaccine (DENV-1 PIV) to Prevent Dengue Disease
Lead Sponsor:
U.S. Army Medical Research and Development Command
Conditions:
Dengue Fever
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever.
Detailed Description
DENV infections can cause self-limited but incapacitating acute illness lasting four to seven days. The illness is characterized by fever, headache, severe pain in muscles, joints, pain behind the eye...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01502735
Start Date
December 1 2011
End Date
September 1 2013
Last Update
April 22 2015
Active Locations (1)
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1
WRAIR, Clinical Trials Center (CTC)
Silver Spring, Maryland, United States, 20910