Protocol Number: 03-I-0263

Title:

Apheresis Procedures to Obtain Plasma or Peripheral Blood Mononuclear Cells for Research Studies

Number:

03-I-0263

Summary:

This study will collect leukocytes (white blood cells) or plasma (the liquid part of the blood) from volunteers for use in studies by NIAID's Vaccine Research Center. The cells or plasma will be used to study different diseases, including HIV and hepatitis, and immune system responses, such as responses to vaccinations, and for other medical research.

The blood cells and plasma will be removed 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 and weigh at least 118 pounds, including participants in other NIH research protocols, may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood tests. Individuals who are pregnant or breast feeding, who have an unstable heart condition, a blood clotting disorder, or another condition that the research staff considers a reason not to undergo apheresis will be excluded from the study.

Participants may be asked to undergo repetitive apheresis procedures, depending upon the requirements of the particular research project for which the cells or plasma are being collected. The study will last for 5 years, but each individual's enrollment is for a 1-year period, which can be extended. Before each apheresis procedure, a brief medical history is taken and weight, pulse, and blood pressure are checked.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

A volunteer 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 samples that will be stored for future research.

4. Weight of 110 pounds or more.

5. Able to provide proof of identity to the acceptance of the clinician completing the enrollment process.

6. If HIV negative, hemoglobin greater than or equal to 12.5 g/dL within the 28 days prior to enrollment or if HIV positive, hemoglobin greater than or equal to 9.0 g/dL within the 28 days prior to enrollment.

7. If HIV negative, platelet count within the normal range within the 28 days prior to enrollment or if HIV positive, platelet count greater than or equal to 50,000/uL within the 28 days prior to enrollment.

EXCLUSION CRITERIA:

A volunteer will be excluded from protocol participation if any of the following criteria apply:

1. Cardiovascular instability as indicated by a) history of medically significant cardiac arrhythmia within the last 5 years, or b) ischemic cardiovascular disease within the last 5 years, pr c) pulse greater than 120/minute on three successive readings during screening, or d) blood pressure greater than 160/100 on three successive readings during screening.

2. Known coagulation disorder.

3. Pregnancy or breast feeding.

4. Any other condition that the attending physician or Apheresis Clinic staff considers a contraindication to the procedure.

Special Instructions: Currently Not Provided

Keywords:

Volunteer

Plasmapheresis

Leukapheresis

Immunology

Leukocyte

Recruitment Keywords:

Healthy Volunteer

HV

Conditions:

Blood Component Removal

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

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.

PMID: 6769278

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. PMID: 6410585

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. PMID: 4030708

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/19/2004