Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells (PBMCs) and Other Specimens for Research Studies
|First Received Date ICMJE||August 8, 2003|
|Last Updated Date||February 14, 2017|
|Start Date ICMJE||August 6, 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 id...|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00067054 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells (PBMCs) and Other Specimens for Research Studies|
|Official Title ICMJE||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.
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 laboratory researches in their work on the development of vaccines for HIV and other infectious diseases, to study the correlates of immunity related to infectious diseases and in laboratory work related to the development and/or validation of immunological assays.
In order to carry out research studies, it is often necessary to obtain larger quantities of plasma or mononuclea cells than can be safely obtained by simple phlebotomy. These components can be safely obtained using apheresis procedures in the Apheresis Clinic of the Clinical Center Department of Transfusion Medicine (DTM). The aphereses performed through this protocol conform to the requirements of the DTM Apheresis Clinic.
Subjects: Volunteers, at least 18 years old, (including participants in other NIH research studies) who agree to donate specimens for research purposes.
Protocol Plan: Subjects will receive information about study procedures and, if willing to participate, will sign the informed consent. The informed consent can be used for as long as one year. If there is an ongoing willingness to donate samples the subject must sign a new consent and have eligibility confirmed at least once per year.
Duration: Individual subjects may donate samples as often as permitted by the protocol. The protocol will undergo continuing review by the IRB annually and remain open if approved and there continues to be a need for plasma or PBMC samples obtained by apheresis or other types of specimens in support of research studies.
Endpoints: This protocol does not have an analysis plan 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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Blood Component Removal|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||3000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
A volunteer must meet all of the inclusion criteria, as follows:
Any medical condition that the attending physician considers a contraindication to the specimen collection procedures that the volunteer will be asked to undergo.
|Ages||18 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States, Puerto Rico|
|Removed Location Countries|
|NCT Number ICMJE||NCT00067054|
|Other Study ID Numbers ICMJE||030263, 03-I-0263|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 26, 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP