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
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
Study Source:
National Institutes of Health Clinical Center (CC)
Oversight Authority:
United States: Federal Government
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 Interventions
There are no available Study Interventions