Safety and Immune Response to Two Doses of rDEN2/4delta30 Dengue Vaccine
- Conditions
- Dengue Fever
- Registration Number
- NCT00920517
- Brief Summary
Dengue fever, caused by dengue viruses, is a major health problem in the tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.
- Detailed Description
Dengue viruses, which cause dengue fever and dengue shock syndrome, are a major cause of morbidity and mortality in several of the world's tropical and subtropical regions. The rDEN2/4delta30(ME) vaccine is a live attenuated dengue virus vaccine that may be protective against dengue virus serotype 2 (DEN2). The purpose of this study is to evaluate the safety and immunogenicity of the rDEN2/4delta30(ME) vaccine in healthy adults.
This study will last approximately 5 to 7 months with 25 study visits. Participants will be randomly assigned into one of two cohorts. Participants in Cohort 1 will receive an injection of rDEN2/4delta30(ME) or placebo vaccine at Days 0 and 180. Participants in Cohort 2 will receive an injection of rDEN2/4delta30(ME) or placebo vaccine at Days 0 and 120. Participants will be asked to record their temperature in a diary for 16 days after each vaccination. At each study visit a physical examination, symptom history, and blood and urine collection will occur.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Good general health as determined by means of the screening procedures.
- Available for the duration of the study (32 weeks for cohort 1 and 23 weeks for cohort 2)
- Willing to use effective methods of contraception
- 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 will affect the ability of the volunteer to understand and cooperate with the requirements of the study protocol
- Neutropenia as defined by an ANC ≤1500/mm3
- ALT level above the laboratory-defined upper limit of normal
- Serum creatinine level above the laboratory-defined upper limit of normal
- 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 subject unable to comply with the protocol.
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- 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 hepatitis B surface antigen (HBsAg) by enzyme-linked immunosorbent assay (ELISA)
- Known immunodeficiency syndrome
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study
- Receipt of a live vaccine within the 4 weeks or a killed vaccine within the 2 weeks prior to entry into the study
- Has had spleen surgically removed
- Receipt of blood products within the 6 months prior to study entry
- 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 yellow fever or dengue vaccine (licensed or experimental)
- Persons who have received any investigational agent in the 30 days prior to study entry
- Persons who have definite plans to travel to a dengue endemic area during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Determine the frequency of vaccine related AEs for each dose, graded by severity. Throughout study Compare the immunogenicity of the two 2-dose regimens of the rDEN2/4Δ30(ME) candidate vaccine as assessed by neutralizing antibody titers to DEN2 At 4 and 6 weeks after each vaccination
- Secondary Outcome Measures
Name Time Method Assess the frequency, quantity, and duration of viremia after each dose of vaccine. Throughout study Determine the number of vaccinees infected with rDEN2/4Δ30(ME) Throughout study Comparison of infectivity rates, safety, and immunogenicity between dose 1 and dose 2 withhin cohort and between cohorts Throughout study Evaluation of the phenotype and activation of peripheral blood mononuclear cells at primary infection and upon reinfection with the DEN2/4Δ30(ME) vaccine. Throughout study
Trial Locations
- Locations (1)
Center for Immunization Research
🇺🇸Baltimore, Maryland, United States
Center for Immunization Research🇺🇸Baltimore, Maryland, United States