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.
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.
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
Participants may be individuals participating solely in this protocol or may be individuals 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 participants from the community. Children are not eligible to participate in this clinical trial.
Other
Prospective
Not listed
Sample collection only
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. Participant 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.
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