Blood Donor CVD 9000: Collection of Blood for In Vitro Studies From Healthy Adults Who Have Received Oral Cholera Vaccine (CVD 103-HgR)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
研究概览
简要总结
This is an open-label, non-randomized study. Volunteers will be vaccinated with the oral cholera vaccine, Vaxchora. Vaxchora has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years to 64 years at the time of enrollment
- •Good general health as determined by a screening evaluation within 28 days before blood donation or vaccination
- •Provides written informed consent prior to initiation of any study procedures
排除标准
- •History of any of the following medical conditions:
- •Cancer in past 5 years (except for basal cell carcinoma of the skin and cervical carcinoma in situ)
- •Heart disease (e.g., hospitalization for a heart attack, coronary artery bypass graft, arrhythmia, or syncope, within past 5 years. Current symptoms of heart disease, such as dyspnea, angina, or orthopnea)
- •Recurrent infections (e.g., more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
- •Current drug or alcohol abuse
- •Active ulcer disease or ongoing intestinal condition
- •Treatment for anemia in last 6 months
- •Treatment with anti-malarial drugs within ten days prior to study vaccination
- •Treatment with antibiotics within 14 days prior to study vaccination
- •Immunodeficiency or immunosuppression from illness or treatment
- •Close contact within 7 days following study vaccination with a person who has an immunodeficiency or immunosuppression from illness or treatment
- •History of cholera infection or cholera vaccination
- •Any of the following complete blood count (CBC) abnormalities during screening:
- •white blood cells (WBC) <0.81 x lower limit of normal (LLN) or > 1.09 x upper limit of normal (ULN)
- •Hemoglobin <0.91 x LLN or >1.18 x ULN (women) or <0.92 x LLN or >1.18 x ULN (men)
- •Platelet count <0.8 x LLN or > 1.2 x ULN
- •Any of the following laboratory abnormalities during screening:
- •serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) >1.5 times normal
- •Positive serology for HIV antibody
- •Poor peripheral venous access for blood donation
- •Other condition that the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or interfere with the scientific integrity of study
- •Positive urine pregnancy test (HCG) on the day of vaccination
研究组 & 干预措施
Vaccination with Oral Cholera Vaccine (Vaxchora)
Volunteers receive immunization with Vaxchora cholera vaccine. Blood draws are performed at subsequent visits.
干预措施: Vaxchora (Drug)
结局指标
主要结局
Change in Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
时间窗: Baseline and Day 29
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 29 after immunization with the CVD103-HgR cholera vaccine.
Change in the Absolute Percentage of Positive CD4+ CD25+/OX40+ T Cells
时间窗: Baseline and Day 3
Change in absolute percentage of positive CD4+ T cell (CD25+/OX40+) responses. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 3 after immunization with the CVD103-HgR cholera vaccine.
Change in Absolute Percentage of Positive T Follicular/Helper 17 Cells Expressing CD154
时间窗: Baseline and Day 29
Change in absolute percentage of positive T follicular/helper 17 cells expressing CD154. T cell responses were defined by changes in T cell activation markers as compared to pre-immunization levels following ex vivo stimulation with cholera specific antigens. Cells were collected at baseline and on day 29 after immunization with the CVD103-HgR cholera vaccine.
次要结局
未报告次要终点
研究者
Marcelo Sztein
Assistant Professor
University of Maryland, Baltimore