Sourcing Human Blood Products to Support the Development of New Vaccines Against Infectious Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- To identify healthy adult volunteers whose blood can be used in complement dependent assays
研究概览
简要总结
We need human blood to understand the immune response to infection and to test promising new vaccines against infectious diseases in the laboratory. One test is called the Serum Bactericidal Assay (or SBA), which is measure of how effective antibodies are at killing certain bacteria and can be an important measure of how effective a new vaccine may be.
The samples would be used in the laboratory analysis of clinical trials of vaccines used in adults and children, and some samples in pre-clinical (animal) experiments testing new vaccines before they enter human-stage testing. Most people have some form of protection against most bacteria already, so not everyone is a suitable blood donor for this laboratory test. We therefore start by taking a small blood sample and test this one before asking for more blood if we found yours suitable for the work we do.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give informed consent for participation in the study
- •Aged between 18 and 70 years
- •In good health as determined by medical history and clinical judgment of the Investigators
- •Able to attend the scheduled visits and to comply with all study procedures
- •If found to be a suitable complement that they are willing to be approached for further donations
排除标准
- •Body weight less than 50kgs
- •Have any known or suspected impairment or alteration of immune function, resulting from, as examples:congenital or acquired immunodeficiency, receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy, receipt of immunoglobulin or any blood product transfusion within the last 3 months
- •Female participants who are pregnant
- •Any chronic illness that could, in the opinion of the Investigators, interfere with immune function or with the donation of large volumes of blood (e.g. thrombocytopaenia or coagulopathy, malabsorption disorders, chronic anaemia)
- •An individual who is on the delegation log for the study
- •Planned blood donation within 4 months of undergoing testing to assess whether the individual is a suitable Complement donor
结局指标
主要结局
To identify healthy adult volunteers whose blood can be used in complement dependent assays
时间窗: At first visit
The intrinsic Serum Bactericidal Assay (SBA) of defined infectious bacterial organisms as either a; 1. complement source with no "intrinsic killing" of defined infectious bacterial organisms 2. complement source with no killing of defined infectious bacterial organisms following IgG depletion 3. complement source with "intrinsic killing" of defined infectious bacterial organisms, to act as a positive control
次要结局
- Further exploratory immunology for the development of immunological assays against infectious diseases(At first visit)