Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells (PBMCs) and Other Specimens for Research Studies
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|ClinicalTrials.gov Identifier: NCT00067054|
Recruitment Status : Recruiting
First Posted : August 11, 2003
Last Update Posted : May 7, 2021
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.
|Condition or disease|
Protocol Design: This protocol is designed to perform collection of human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or body fluids to support research studies. These samples will be used by researchers in their work on the development of vaccines, to study the correlates of immunity related to infectious diseases and in laboratory work related to the development and/or validation of immunological assays. Standard phlebotomy and apheresis procedures will be utilized to safely obtain necessary quantities of blood and cells.
Objectives: Obtain human biological specimens such as blood (via phlebotomy), plasma or PBMC samples (via apheresis), mucosal secretions, skin swabs, body fluids or skin biopsy to support medical research.
Study Population: Adults ages 18 years and older.
Protocol Plan: Subjects, including healthy volunteers and infectious disease patients who consent to participate in this study, will undergo standard medical procedures to obtain biological specimens for research purposes only. The signed informed consent is valid for one year; at least once per year, the subject must re-consent and eligibility should be re-confirmed.
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 as long as there continues to be a need for human biological specimens for research studies.
Endpoints: 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 subject identification number. Subject data, such as demographic information, aspects of medical history, laboratory parameters, recent immunizations or medications, HLA type, genetic tests and other medical information may be provided (identified by study number, but not subject name) to researchers if needed to support the objectives of the laboratory research.
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||VRC 200: A Multicenter Specimen Collection Protocol to Obtain Human Biological Samples for Research Studies|
|Actual Study Start Date :||September 10, 2003|
Sample Collection Only
- Sample Collection Only [ Time Frame: end of study ]This protocol does not have an analysis primary outcome measure, but rather 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 protocol identification number. Subject data, such as demographic information, aspects of medical history, laboratory parameters, recent immunizations or medications, HLA type, genetic tests and other medical information may be provided (identified by study number, but not subject name) to researchers if needed to support the objectives of the laboratory research.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067054
|Contact: Ingelise Gordon, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: VRC Clinic 301-451-8715 firstname.lastname@example.org|
|Principal Investigator:||Martin R Gaudinski, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|