This study is currently recruiting participants.
Number
03-I-0263
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Volunteer; Plasmapheresis; Leukapheresis; Immunology; Leukocyte; Natural History
Recruitment Keyword(s)
None
Condition(s)
Sample Collection
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
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.
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INCLUSION CRITERIA: A participant must meet all 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 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. 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 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: 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 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 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
A participant must meet all 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 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.
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 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:
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 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
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)
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
Principal Investigator
Referral Contact
For more information: