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

Launched by U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND · Dec 29, 2011

Keywords

ClinConnect Summary

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 eyes, and a rash. DENV infection can be complicated by the development of hemorrhagic fever (DHF) or shock syndrome (DSS), which is manifested by plasma leakage and a bleeding diathesis or frank hemorrhage. DHF is fatal in at least 0.5% of pediatric cases but rarely in adults. People, particularly children, living in hyper-endemic areas who have antibodies from an earlier dengue infection with one...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)