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

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ClinicalTrials.gov Identifier: NCT00067054
Recruitment Status : Recruiting
First Posted : August 11, 2003
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

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.


Condition or disease
Sample Collection

Detailed Description:

Protocol Design: 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: 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: Adults ages 18 years and older.

Protocol Plan: Subjects, including healthy volunteers and infectious disease patients who consent to participate in this study, will undergo standard medical procedures to obtain biological specimens for research purposes only. 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: 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 as long as there continues to be a need for human biological specimens for research studies.

Endpoints: 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. Subject data, such as demographic information, aspects of medical history, laboratory parameters, recent immunizations or medications, HLA type, genetic tests and other medical information may be provided (identified by study number, but not subject name) to researchers if needed to support the objectives of the laboratory research.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: VRC 200: A Multicenter Specimen Collection Protocol to Obtain Human Biological Samples for Research Studies
Actual Study Start Date : September 10, 2003

Group/Cohort
1
Sample Collection Only



Primary Outcome Measures :
  1. Sample Collection Only [ Time Frame: end of study ]
    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 only by protocol identification number. Subject data, such as demographic information, aspects of medical history, laboratory parameters, recent immunizations or medications, HLA type, genetic tests and other medical information may be provided (identified by study number, but not subject name) to researchers if needed to support the objectives of the laboratory research.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067054


Contacts
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Contact: Ingelise Gordon, R.N. (301) 451-8785 vaccines@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: VRC Clinic    301-451-8715    vaccines@nih.gov   
United States, Washington
EvergreenHealth Medical Center Recruiting
Kirkland, Washington, United States, 98034
Contact: Diego Lopez de Castilla, MD    425-899-5100    dlopezdecastilla@evergreenhealthcare.org   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Martin R Gaudinski, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00067054    
Other Study ID Numbers: 030263
03-I-0263
First Posted: August 11, 2003    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 10, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Volunteer
Plasmapheresis
Leukapheresis
Immunology
Leukocyte