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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 : August 16, 2019
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 laboratory researches 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.

Subjects: Adults ages 18 years and older

Protocol Plan: Subjects who consent to participate will undergo standard 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

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 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..


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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 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 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 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


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) 451-8715 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   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Grace L Chen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00067054     History of Changes
Other Study ID Numbers: 030263
03-I-0263
First Posted: August 11, 2003    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 8, 2019

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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
Healthy Volunteer
HV