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 : December 2, 2022
|First Submitted Date||August 8, 2003|
|First Posted Date||August 11, 2003|
|Last Update Posted Date||December 2, 2022|
|Actual Study Start Date||September 10, 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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.
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells (PBMCs) and Other Specimens for Research Studies|
|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.
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.
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.
Adults ages 18 years and older.
Subjects, including healthy volunteers and infectious disease patients who consent to participate in this study, will undergo medical procedures to obtain biological specimens. 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.
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 if there continues to be a need for human biological specimens for research studies.
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. Non-personally identifying information (identified by Subject ID only) such as demographic information, aspects of 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.
|Study Design||Observational Model: Other
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Participants may be subjects participating solely in this protocol or may be subjects in other VRC studies from whom more cells are needed for research than can be collected by routine phlebotomy.At the VRC site, NIH employees and members of their immediate families may participate in this protocol. The UPR MSC site will only enroll subjects from the community. Children are not eligible to participate in this clinical trial.|
Sample collection only
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
A subject must meet all of the inclusion criteria, as follows:
A subject will be excluded from protocol participation if there is presence of a condition that the attending physician considers to be a contraindication to the specimen collection procedures.
SKIN BIOPSY ELIGIBILITY CRITERIA:
The skin biopsy eligibility includes the following:
APHERESIS ELIGIBILITY CRITERIA:
In order to undergo apheresis procedures, a subject must have no medical contraindications. All apheresis procedures performed under this protocol are solely for research purposes.
Subjects participating in an active clinical research protocol may participate in the apheresis protocol if the total amount of blood drawn does not exceed NIH guidelines or a site's institutional guidelines. A study clinician will complete a checklist for apheresis eligibility before referring a subject for apheresis. At the NIH, prior to scheduled procedure, the subject must have a venous assessment performed by the Apheresis staff to determine suitability for apheresis.
For Healthy Volunteers:
A healthy volunteer must meet all of the following criteria:
Infectious Disease Patients:
A patient with an infectious disease must meet all of the following criteria:
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries||Puerto Rico|
|Other Study ID Numbers||030263
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||Not Provided|
|Current Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )|
|Original Responsible Party||Not Provided|
|Current Study Sponsor||National Institute of Allergy and Infectious Diseases (NIAID)|
|Original Study Sponsor||Same as current|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 26, 2022|