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

Description

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

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Study Overview

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Study Details

Study overview

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. ...

VRC 200: A Multicenter Specimen Collection Protocol to Obtain Human Biological Samples for Research Studies

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

Condition
Sample Collection
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institutes of Health Clinical Center, Bethesda, Maryland, United States, 20892

Kirkland

EvergreenHealth Medical Center, Kirkland, Washington, United States, 98034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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
  • 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 to apheresis 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

National Institute of Allergy and Infectious Diseases (NIAID),

Lesia K Dropulic, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

N/A