Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells (PBMCs) and Other Specimens for Research Studies
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/6/2019 |
| Start Date: | August 8, 2003 |
| Contact: | Ingelise Gordon, R.N. |
| Email: | vaccines@nih.gov |
| Phone: | (301) 451-8715 |
VRC 200: A Multicenter Specimen Collection Protocol to Obtain Human Biological Samples for Research Studies
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.
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.
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.
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.
- 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
We found this trial at
2
sites
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 301-451-8715
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