VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To use specimens and accumulated data for enhancement of understanding the correlates of immune protection.
研究概览
简要总结
Background:
- The Vaccine Research Center (VRC) is dedicated to understanding immune responses associated with prevention and treatment of infectious diseases. To study these immune responses, researchers need to collect specimens and images from individuals who have recently had a vaccination or recovered from an infection. These specimens and images are used to study different diseases and immune responses, and can be used to investigate ways to prevent or treat different medical conditions.
Objectives:
- To evaluate blood and other tissue samples for immune responses to vaccines and natural infections.
Eligibility:
- Healthy volunteers at least 18 years of age who agree to donate specimens for research purposes.
Design:
- Participants will have clinical evaluations and will be asked to provide some of the following samples, depending on the research question being addressed. All procedures and sample donations are optional and voluntary:
- Blood samples through regular blood draws (for whole blood) and apheresis (to collect specific parts of the blood such as plasma or white blood cells)
- Urine, semen, saliva, or vaginal swab samples
- Tissue samples or biopsy specimens
- Undergo procedures such as bronchoscopy (lung and respiratory tract), gastrointestinal endoscopy (stomach and upper intestinal tract), or colonoscopy (lower intestinal tract) to obtain tissue samples
- Undergo imaging studies such as positron emission tomography (PET) or computed tomography (CT) scans
Duration of participation is variable depending on the research question but will usually last up to 1 year.
- Participants will be compensated for participation.
详细描述
Protocol Design:
This is a specimen and data collection protocol designed with the research purpose of understanding the immune responses to vaccines and infections in adult participants. The information gained will enhance the knowledge of immune correlates of protection and will help in laboratory work related to the development and validation of immunological assays. This protocol will allow Vaccine Research Center (VRC) investigators and collaborators to evaluate tissue level immune responses in participants who are recipients of Food and Drug Administration (FDA)-licensed vaccines, recipients of investigational vaccines, control subjects, and participants naturally infected with infectious diseases as examples of naturally acquired immunity. Immune responses will be evaluated using collection of blood, body fluids, mucosal and tissue samples to perform clinical evaluations for research rather than therapeutic goals. Imaging using ultrasonography may be employed to image tissues such as lymph nodes to guide sampling. Detailed studies of immune responses in blood, body fluids and a diversity of tissue types, including a variety of mucosal surfaces, will further the understanding of immune responses following vaccination or recovery from an infectious disease and will advance development of vaccines against existing, new, and re-emerging pathogens.
Subjects:
Up to 500 participants 18 years of age and older who agree to collection, use, and storage of specimens and images for research purposes will be enrolled. Participants must not be pregnant or breast-feeding for certain study sample collection procedures or to receive FDA-licensed live virus vaccines.
Study Plan:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •18 years of age or older.
- •Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- •Able and willing to complete the informed consent process.
- •Willing to donate specimens for storage to be used for research.
排除标准
- •Any medical, psychiatric, occupational condition or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant s ability to give informed consent.
- •Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), use of anticoagulant medications for an ongoing medical condition, significant bruising or bleeding difficulties with intramuscular injections or blood draws. [Note: Participants taking anticoagulants, such as aspirin, prophylactically may be considered on a case to case basis.]
研究组 & 干预措施
1
Participants 18 years of age or older willing to donate blood and tissue specimens and participate in imaging studies to evaluate the components of the immune system
结局指标
主要结局
To use specimens and accumulated data for enhancement of understanding the correlates of immune protection.
时间窗: Throughout the study
By sample collection and imaging studies
To evaluate blood, body fluid, and tissue immune responses and pathogen dynamics of naturally infected and antigen-na(SqrRoot) ve subjects
时间窗: Throughout the study
By sample collection and imaging studies
To evaluate innate, humoral, and cellular immune responses and pathogen dynamics in the context of vaccination in the blood, body fluids, excretions, and tissues
时间窗: Throughout the study
By sample collection and imaging studies
次要结局
未报告次要终点