Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells… (NCT00067054) | Clinical Trial Compass
RecruitingNot Applicable
Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells (PBMCs) and Other Specimens for Research Studies
United States, Puerto Rico3,000 participantsStarted 2003-09-10
Plain-language summary
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 participant 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....
Who can participate
Age range3 Years
SexALL
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Inclusion criteria
✓. Age 18 years or older
✓. Able and willing to complete the informed consent process
✓. Willing to provide blood or other samples that will be stored indefinitely and used for future research
✓. Able to provide proof of identity to the acceptance of the clinician completing the enrollment process; when informed consent is obtained by telephone or a telehealth visit, the investigator obtaining consent will also confirm proof of identity.
✓. Children aged 3 to 17 years inclusive, and at least 12 kg in weight.
✓. Capability of the legal adult guardian of the child to understand and comply with the planned study procedures.
✓. Capability of the legal adult guardian of the child to provide written informed consent.
✓. Willing to have blood drawn or collection of urine, fecal samples, oral secretions, or swabs of mucosa that will be stored indefinitely and used for future research.
Exclusion criteria
What they're measuring
1
Sample collection only
Timeframe: end of study
Trial details
NCT IDNCT00067054
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Acute or chronic illness that, in the opinion of the investigator or designee, precludes participation in the study.
✕. Factors related to the legal guardian that, in the judgment of the investigator or designee, may affect the objective decision-making of the legal guardian.
✕. Age 18 years or older
✕. No known allergies to the local anesthetic to be used