Dengue Hemorrhagic Fever Clinical Trial
Official title:
Phase I Evaluation of the Safety and Immunogenicity of rDEN4delta30 Lot# 109A, a Live Attenuated DEN4 Vaccine, in Healthy Flavivirus-naïve Adult Volunteers.
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Center for Immunization Research, Johns Hopkins School of Public Health | Baltimore | Maryland |
United States | University of Vermont Vaccine Testing Center | Burlington | Vermont |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Swaminathan S, Khanna N. Dengue: recent advances in biology and current status of translational research. Curr Mol Med. 2009 Mar;9(2):152-73. Review. — View Citation
Tan GK, Alonso S. Pathogenesis and prevention of dengue virus infection: state-of-the-art. Curr Opin Infect Dis. 2009 Jun;22(3):302-8. doi: 10.1097/QCO.0b013e328329ae32. Review. — View Citation
Wiwanitkit V. Dengue vaccines: a new hope? Hum Vaccin. 2009 Aug;5(8):566-7. Epub 2009 Aug 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunogenicity of vaccine candidate, as assessed by neutralizing antibody titers to DEN4 | At Weeks 4 and 6 following vaccination | No | |
Primary | Safety of vaccine candidate, as assessed by the frequency of vaccine-related adverse events, graded by severity | Throughout study | Yes | |
Secondary | Frequency, quantity, and duration of viremia following vaccination | Throughout study | No | |
Secondary | Number of vaccinees infected with vaccine virus | Throughout study | No | |
Secondary | Infectivity rates, safety, and immunogenicity of a single dose of candidate vaccine compared with previous rates from a previous lot of similar vaccine | Throughout study | Yes | |
Secondary | Durability of antibody response | At 26 Weeks following vaccination | No | |
Secondary | Phenotype of peripheral blood mononuclear cells at primary infection with the rDEN4delta30 vaccine | Throughout study | No | |
Secondary | Immunopathological mechanism of vaccine-associated rash in those volunteers who are willing to undergo skin biopsy | Throughout study | No | |
Secondary | Cellular immune response to primary infection with the rDEN4delta30 vaccine | Throughout study | No |
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