Safety of and Immune Response to DEN4 Vaccine Component Candidate for Dengue Virus

Completed · Phase 1 · Has a placebo group

Conditions studied: Dengue Shock Syndrome, Dengue Hemorrhagic Fever

In brief

Infection with dengue viruses is one of the leading causes of hospitalization and death in children in several tropical Asian counties. The World Health Organization (WHO) estimates that these viruses are responsible for more than 50 million cases of dengue fever (DF) and approximately 0.5 million cases of the more severe disease, dengue hemorrhagic fever/ shock syndrome (DHF/DSS) annually. Because dengue viruses are endemic in most tropical and subtropical regions, keeping more than 2 billion persons at risk for acquiring dengue, the WHO has made development of a dengue vaccine a top priority. The purpose of this study is to evaluate the safety and effectiveness of a candidate DEN4 vaccine aimed at preventing infection with dengue virus serotype 4.

Key facts

Study ID

NCT00919178

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

70

Starts

2009-07-01

Expected to finish

2010-05-01

Last updated by the study team

2013-01-03

Who can join

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

You may qualify if…

• Willing and able to provide informed consent
• Good general health as determined by physical examination, laboratory screening, and review of medical history
• Available for the duration of the study, approximately 26 weeks postvaccination
• Willing to use acceptable forms of birth control. More information on this criterion can be found in the study protocol.

You may not qualify if…

• Currently breast-feeding, or pregnant
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
• Behavioral, cognitive, or psychiatric disease that in the opinion of the Investigator affects the ability of the volunteer to understand and cooperate with the requirements of the study protocol
• Screening laboratory values of Grade 1 or above for absolute neutrophil count(ANC), ALT, and serum creatinine, as defined in this protocol
• Any other condition that in the opinion of the Investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the volunteer unable to comply with the protocol
• Any significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by volunteer history
• History of a severe allergic reaction or anaphylaxis
• Severe asthma (emergency room visit or hospitalization within the last 6 months)
• Positive HIV-1 serology by screening and confirmatory assays
• Positive for hepatitis C virus (HCV) by screening and confirmatory assays
• Positive for hepatitis B virus (HBV) by hepatitis B surface antigen (HBsAg) screening
• Any known immunodeficiency syndrome
• Use of anticoagulant medications
• Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. Immunosuppressive dose of corticosteroids is defined as 10 mg or more prednisone equivalent per day for 14 or more days.
• Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 42 days following vaccination
• History of a surgical splenectomy
• Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following vaccination
• History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
• Previous receipt of a flavivirus vaccine (licensed or experimental)
• Receipt of any investigational agent in the 42 days before or after vaccination
• Volunteer has definite plans to travel to a dengue endemic area during the study

Where it is running

• Center for Immunization Research, Johns Hopkins School of Public Health — Baltimore, Maryland, United States
• University of Vermont Vaccine Testing Center — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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