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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 : December 28, 2017
Information provided by (Responsible Party):

Study Description
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
Blood Component Removal

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 for HIV and other infectious diseases, to study the correlates of immunity related to infectious diseases and in laboratory work related to the development and/or validation of immunological assays.

In order to carry out research studies, it is often necessary to obtain larger quantities of plasma or mononuclea cells than can be safely obtained by simple phlebotomy. These components can be safely obtained using apheresis procedures in the Apheresis Clinic of the Clinical Center Department of Transfusion Medicine (DTM). The aphereses performed through this protocol conform to the requirements of the DTM Apheresis Clinic.

Subjects: Volunteers, at least 18 years old, (including participants in other NIH research studies) who agree to donate specimens for research purposes.

Protocol Plan: Subjects will receive information about study procedures and, if willing to participate, will sign the informed consent. The informed consent can be used for as long as one year. If there is an ongoing willingness to donate samples the subject must sign a new consent and have eligibility confirmed at least once per year.

Duration: Individual subjects may donate samples as often as permitted by the protocol. The protocol will undergo continuing review by the IRB annually and remain open if approved and there continues to be a need for plasma or PBMC samples obtained by apheresis or other types of specimens in support of research studies.

Endpoints: This protocol does not have an analysis plan 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.

Study Design

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
Study Start Date : August 8, 2003
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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 id...

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

A volunteer must meet all of the inclusion criteria, as follows:

  1. Age 18 years or older.
  2. Able to provide informed consent.
  3. Willing to provide blood or other samples to 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 a clinician who will be performing the sample collection will review the proof of identity.


Any medical condition that the attending physician considers a contraindication to the specimen collection procedures that the volunteer will be asked to undergo.

Contacts and Locations

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

Contact: Ingelise Gordon, R.N. (301) 451-8715 vaccines@nih.gov

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   
Puerto Rico
University of Puerto Rico Recruiting
Rio Piedras Station, Puerto Rico
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Grace L Chen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00067054     History of Changes
Other Study ID Numbers: 030263
First Posted: August 11, 2003    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 19, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Healthy Volunteer