Sample Collection Clinical Trial
Official title:
VRC 200: A Multicenter Specimen Collection Protocol to Obtain Human Biological Samples for Research Studies
This study collects specimens from volunteers for use in studies by NIAID's Vaccine Research Center. A number of different types of specimens or samples can be collected, including blood, urine, body fluids or secretions, skin swabs, or skin biopsies. The samples are used for medical research, including the study of HIV, hepatitis, and other diseases; immune system responses, such as responses to vaccinations or infections; and for research on vaccine development. Blood samples may be collected either by ordinary blood drawing (phlebotomy) or by apheresis, a procedure for collecting a larger quantity of blood cells or plasma than would be possible through simple blood drawing. For this procedure, the subject lies on a recliner or couch. Blood is removed through a needle in the vein of one arm and spun in a machine that separates out the desired component (plasma or white blood cells). The remainder of the blood is returned either through the same needle or through a needle in the other arm. The procedure takes about 1 to 3 hours. Volunteers who are 18 years of age and older, including participants in other NIH research protocols, may be eligible. Individuals who have a condition that the research staff considers a reason not to make a sample donation will be excluded from the study. Participants may have only one sample collected or may be asked to undergo repetitive sample collection procedures, depending upon the requirements of the particular research project for which the samples are being collected. Each individual's enrollment is for a 1-year period, which can be extended.
Study Description: This protocol is designed to collect human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or body fluids to support medical research. These samples will be used by researchers in their work on the development of vaccines and monoclonal antibodies, to study the correlates of immunity related to infectious diseases and allergies, and in laboratory work related to the development and/or validation of immunological and other relevant assays. Standard phlebotomy and apheresis procedures will be utilized to safely obtain necessary quantities of blood and cells. Objectives: To obtain human biological specimens such as blood (via phlebotomy), plasma or peripheral blood mononuclear cells (PBMC) samples (via apheresis), mucosal secretions, skin swabs, body fluids, and skin biopsy to support medical research. Study Population: Adults ages 18 years and older. Protocol Plan: Subjects, including healthy volunteers and patients with an infection or with an allergic or autoimmune condition who consent to participate in this study, will undergo standard medical procedures to obtain biological specimens. Samples may be collected at clinic visits by study staff or at home by the participant and shipped to the NIH by the participant. Study Duration: Individual subjects may donate samples as often as permitted by their institution s guidelines. The IRB-approved protocol will remain open and undergo annual continuing review by the IRB. Endpoints: There are no specific endpoints in this study, as samples are collected for investigations conducted in research laboratories to address questions related to vaccine and monoclonal antibody development, as noted in the study description. Therefore, there is no analysis plan for this protocol. This protocol will be conducted in accordance with Good Clinical Practices for human research solely for the purpose of obtaining samples for research laboratories. Samples will be identified only by a subject identification number. Non-personally identifying information that will be linked to a subject ID only, such as demographic information, aspects of the medical history, laboratory parameters, recent immunizations or medications, genetic tests and other medical information, may be provided to researchers if needed to support the objectives of the laboratory research. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05186311 -
BD MiniDraw™ Capillary System Clinical Equivalence Study
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