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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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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Eligibility

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


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Citations:

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.

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.

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

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



OPS Team, VRC
National Institute of Allergy and Infectious Diseases (NIAID)

Not Listed
vaccines@nih.gov

VRC Clinic
National Institute of Allergy and Infectious Diseases (NIAID)
Vaccine Research Center
National Institutes of Health (NIH)
Bethesda, MD 20892

(301) 451-8715
vaccines@nih.gov

Clinical Trials Number:

NCT00067054

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