Safety and Immunogenicity of a 2-Dose Regimen of rDEN2/4Δ30 Dengue Vaccine With Boosting at 4 Versus 6 Months
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Determine the frequency of vaccine related AEs for each dose, graded by severity.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Determine the frequency of vaccine related AEs for each dose, graded by severity.
时间窗: 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
时间窗: At 4 and 6 weeks after each vaccination
次要结局
- 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)