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

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.

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Study Overview

• Status: Recruiting
• Conditions: Sample Collection

Detailed Description

Study Description:

This protocol is designed to collect human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or body fluids to support medical research. These samples will be used by researchers in their work on the development of vaccines and monoclonal antibodies, to study the correlates of immunity related to infectious diseases and allergies, and in laboratory work related to the development and/or validation of immunological and other relevant assays. Standard phlebotomy and apheresis procedures will be utilized to safely obtain necessary quantities of blood and cells.

Objectives:

To obtain human biological specimens such as blood (via phlebotomy), plasma or peripheral blood mononuclear cells (PBMC) samples (via apheresis), mucosal secretions, skin swabs, body fluids, and skin biopsy to support medical research.

Study Population:

Adults ages 18 years and older.

Protocol Plan:

Subjects, including healthy volunteers and patients with an infection or with an allergic or autoimmune condition who consent to participate in this study, will undergo medical procedures to obtain biological specimens. Samples may be collected at clinic visits by study staff or at home by the participant and shipped to the NIH by the participant. 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.

Study Duration:

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.

Endpoints:

There are no specific endpoints in this study, as samples are collected for investigations conducted in research laboratories to address questions related to vaccine and monoclonal antibody development, as noted in the study description. Therefore, 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 that will be linked to a 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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: OPS Team, VRC; Phone Number: Not Listed; Email: vaccines@nih.gov

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • Active, not recruiting
    • University of Puerto Rico Medical Sciences Campus
• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: VRC Clinic; Phone Number: 301-451-8715; Email: vaccines@nih.gov
  • Washington
    • Kirkland, Washington, United States, 98034
      • Completed
      • EvergreenHealth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

• INCLUSION CRITERIA:

A subject must meet all of the inclusion criteria, as follows:

1. Age 18 years or older
2. Able and willing to complete the informed consent process
3. Willing to provide blood or other samples that will be stored indefinitely and used for future research
4. 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.

EXCLUSION CRITERIA:

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:

1. No known allergies to the local anesthetic to be used
2. No history of keloid formation
3. No known coagulation disorders
4. Not pregnant or breast feeding

APHERESIS ELIGIBILITY CRITERIA:

To undergo an apheresis procedure, 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 the scheduled procedure, the subject must have a venous assessment performed by apheresis staff to determine suitability for apheresis.

For Healthy Volunteers:

A healthy volunteer must meet all the following criteria prior to the procedure:

1. Afebrile (temperature <= 37.50 degrees C)
2. Weight >=110 pounds
3. Adequate bilateral antecubital venous access
4. Hemoglobin >= 12.5 g/dL for women; >= 13.0 g/dL for men within 56 days prior to apheresis procedure.
5. Platelets > 150,000 K/uL within 56 days prior toapheresis procedure.
6. No cardiovascular instability as indicated by a) history of medically significant cardiac arrhythmia within the last 12 months, or b) ischemic cardiovascular disease within the last 12 months, or c) heart rate outside of the 50 - 100 beats/minute interval (on 3 successive readings), or d) blood pressure greater than 180 mmHg (systolic) or 100 mmHg (diastolic) on 3 successive readings
7. No current lung or kidney disease
8. No known coagulation disorder
9. No sickle cell disease
10. No active or chronic hepatitis
11. No intravenous injection drug use in the past 5 years
12. Not breast feeding
13. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) performed by a VRC study clinician within 72 hours prior to the apheresis procedure

Infectious Disease Patients:

A patient with an infectious disease must meet all of the following criteria:

1. Weight >= 110 pounds
2. Afebrile (temperature <= 37.5 degrees C)
3. Adequate bilateral antecubital venous access
4. No cardiovascular instability as indicated by a) history of medically significant cardiac arrhythmia within the last 12 months, or b) ischemic cardiovascular disease within the last 12 months, or c) heart rate outside of the 50 - 100 beats/minute (on 3 successive readings), or d) blood pressure greater than 180/100 mmHg (on 3 successive readings)
5. No current lung or kidney disease
6. No known coagulation disorder
7. No receipt of clotting factor concentrates in the past 5 years
8. Hemoglobin >= 9.0 g/dL within 56 days prior to apheresis procedure
9. Platelets >= 50,000 K/uL within 56 days prior to apheresis procedure
10. White Blood Cell WBC >= 2.0 K/uL within 56 days prior to apheresis procedure
11. Not breast feeding
12. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) performed by a VRC study clinician within 72 hours prior to the apheresis procedure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Sample collection only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. 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.	end of study

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Lesia K Dropulic, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2003

Study Registration Dates

• First Submitted: August 8, 2003
• First Submitted That Met QC Criteria: August 8, 2003
• First Posted (Estimated): August 11, 2003

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: February 29, 2024

More Information

Terms related to this study

• Keywords: Immunology; Leukapheresis; Natural History; Volunteer; Leukocyte; Plasmapheresis
• Other Study ID Numbers: 030263; 03-I-0263

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No