Bethesda, Maryland 20892

  • Sample Collection

Purpose:

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.


Study summary:

Study Description: This protocol is designed to perform collection of human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or body fluids to support research studies. These samples will be used by researchers in their work on the development of vaccines, to study the correlates of immunity related to infectious diseases and in laboratory work related to the development and/or validation of immunological assays. Standard phlebotomy and apheresis procedures will be utilized to safely obtain necessary quantities of blood and cells. Objectives: <TAB> Obtain human biological specimens such as blood (via phlebotomy), plasma or PBMC samples (via apheresis), mucosal secretions, skin swabs, body fluids or skin biopsy to support medical research. Study Population:<TAB> Adults ages 18 years and older. Protocol Plan:<TAB> Subjects, including healthy volunteers and infectious disease patients who consent to participate in this study, will undergo medical procedures to obtain biological specimens. 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:<TAB> 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 if there continues to be a need for human biological specimens for research studies. Endpoints: <TAB> 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 (identified by 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.


Criteria:

- 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 for future research 4. Able to provide proof of identity to the acceptance of the clinician completing the enrollment process; when the telephone consent process is used, the clinician performing the sample collection will review and confirm the 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: In order to undergo apheresis procedures, 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 scheduled procedure, the subject must have a venous assessment performed by the Apheresis staff to determine suitability for apheresis. For Healthy Volunteers: A healthy volunteer must meet all of the following criteria: 1. Afebrile (temperature <= 37.5 degrees C) 2. Weight >=110 pounds 3. Adequate bilateral antecubital venous access 4. Hemoglobin >= 12.5 g/dL for females; >= 13.0 g/dL for men 5. Platelets > 150,000 K/uL 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 9. Platelets >= 50,000 K/uL 10. WBC >= 2.0 K/uL 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 is Available At:


Original ID:

030263


NCT ID:

NCT00067054


Secondary ID:

03-I-0263


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

3000


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Lesia K Dropulic, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Primary Contact:OPS Team, VRC
Not Listed
vaccines@nih.gov

Study Dates

Start Date:September 10, 2003
Verification Date:October 26, 2022
Last Changed Date:December 1, 2022
First Received Date:August 8, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:Sample collection only
Time Frame:end of study
Safety Issues:False
Description: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 o

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Sample collection only

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation: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.
PMID:6769278
Reference Type:Reference
Citation: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.
PMID:6410585
Reference Type:Reference
Citation: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.
PMID:4030708

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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