Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells (PBMCs) and Other Specimens for Research Studies

NCT00067054 | Recruiting

• 2 other identifiers: 03026303-I-0263
• Study Type: observational
• Target: 3,000
• Locations: 2 countries
• Sites: 3

Brief 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....

Conditions

Sample Collection

Keywords

Volunteer; Plasmapheresis; Leukapheresis; Immunology; Leukocyte; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  end of study

Study Arms (1)

1

Sample collection only

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• The legal adult guardian of the children can provide proof of identity for the child and for themselves to the satisfaction of the clinician completing the enrollment process.

You may not qualify if:

• A participant 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.
• 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.
• SKIN BIOPSY ELIGIBILITY CRITERIA FOR ADULTS ONLY:
• The skin biopsy eligibility includes the following:
• Age 18 years or older
• No known allergies to the local anesthetic to be used
• No history of keloid formation
• No known coagulation disorders
• Not pregnant or breast feeding
• APHERESIS ELIGIBILITY CRITERIA FOR ADULTS ONLY:
• To undergo an apheresis procedure, a participant must have no medical contraindications. All apheresis procedures performed under this protocol are solely for research purposes.
• Participants involved 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 participant for apheresis.
• At the NIH, prior to the scheduled procedure, the participant must have a venous assessment performed by apheresis staff to determine suitability for apheresis.
• For Healthy Volunteers:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

EvergreenHealth Medical Center

Kirkland, Washington, 98034, United States

COMPLETED

University of Puerto Rico Medical Sciences Campus

San Juan, 00921, Puerto Rico

ACTIVE NOT RECRUITING

Related Publications (4)

• Strauss RG, Maguire LC, Koepke JA, Thompson JS. Effect of intermittent-flow centrifugation leukapheresis on donor leukocyte counts. Acta Haematol. 1980;63(3):128-31. doi: 10.1159/000207383.

  PMID: 6769278 BACKGROUND

• Heal JM, Horan PK, Schmitt TC, Bailey G, Nusbacher J. Long-term follow-up of donors cytapheresed more than 50 times. Vox Sang. 1983;45(1):14-24. doi: 10.1111/j.1423-0410.1983.tb04118.x.

  PMID: 6410585 BACKGROUND

• Braine HG, Elfenbein GJ, Mellits ED. Peripheral blood lymphocyte numbers, lymphocyte proliferative responses in vitro, and serum immunoglobulins in regular hemapheresis donors. J Clin Apher. 1985;2(3):213-8. doi: 10.1002/jca.2920020302.

  PMID: 4030708 BACKGROUND

• Zhou T, Teng IT, Olia AS, Cerutti G, Gorman J, Nazzari A, Shi W, Tsybovsky Y, Wang L, Wang S, Zhang B, Zhang Y, Katsamba PS, Petrova Y, Banach BB, Fahad AS, Liu L, Acevedo SNL, Madan B, de Souza MO, Pan X, Wang P, Wolfe JR, Yin M, Ho DD, Phung E, DiPiazza A, Chang L, Abiona O, Corbett KS, DeKosky BJ, Graham BS, Mascola JR, Misasi J, Ruckwardt T, Sullivan NJ, Shapiro L, Kwong PD. Structure-Based Design with Tag-Based Purification and In-Process Biotinylation Enable Streamlined Development of SARS-CoV-2 Spike Molecular Probes. SSRN [Preprint]. 2020 Jul 21:3639618. doi: 10.2139/ssrn.3639618.

  PMID: 32742241 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Lesia K Dropulic, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OPS Team, VRC

CONTACT

Not Listed; vaccines@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2003
• First Posted: August 11, 2003
• Study Start: September 10, 2003
• Last Updated: May 1, 2026

Record last verified: 2026-04-07

Locations

US (2); PR (1)