Sample CollectionNCT00067054
Apheresis and Specimen Collection Procedures to Obtain Plasma, Peripheral Blood Mononuclear Cells (PBMCs) and Other Specimens for Research Studies
An observational study of Sample Collection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sample Collection
- How many people
- 3,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Sep 2003to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants may be individuals participating solely in this protocol or may be individuals 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 participants from the community. Children are not eligible to participate in this clinical trial.
Who may be able to join
- A participant must meet all the inclusion criteria, as follows:
- Age 18 years or older
- Able and willing to complete the informed consent process
- Willing to provide blood or other samples that will be stored indefinitely and used for future research
- Able to provide proof of identity to the acceptance of the clinician completing the enrollment process; when informed consent is obtained by telephone or a telehealth visit, the investigator obtaining consent will also confirm proof of identity.
- Children aged 3 to 17 years inclusive, and at least 12 kg in weight.
Show all 10Show fewer
- Capability of the legal adult guardian of the child to understand and comply with the planned study procedures.
- Capability of the legal adult guardian of the child to provide written informed consent.
- Willing to have blood drawn or collection of urine, fecal samples, oral secretions, or swabs of mucosa that will be stored indefinitely and used for future research.
- The legal adult guardian of the children can provide proof of identity for the child and for themselves to the satisfaction of the clinician completing the enrollment process.
Who cannot join
- A participant 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.
- Acute or chronic illness that, in the opinion of the investigator or designee, precludes participation in the study.
- Factors related to the legal guardian that, in the judgment of the investigator or designee, may affect the objective decision-making of the legal guardian.
- SKIN BIOPSY ELIGIBILITY CRITERIA FOR ADULTS ONLY:
- The skin biopsy eligibility includes the following:
- Age 18 years or older
Show all 45Show fewer
- No known allergies to the local anesthetic to be used
- No history of keloid formation
- No known coagulation disorders
- Not pregnant or breast feeding
- APHERESIS ELIGIBILITY CRITERIA FOR ADULTS ONLY:
- To undergo an apheresis procedure, a participant must have no medical contraindications. All apheresis procedures performed under this protocol are solely for research purposes.
- Participants involved 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 participant for apheresis.
- At the NIH, prior to the scheduled procedure, the participant must have a venous assessment performed by apheresis staff to determine suitability for apheresis.
- For Healthy Volunteers:
- A healthy volunteer must meet all the following criteria prior to the procedure:
- Age 18 years or older
- Afebrile (temperature <= 37.5 degrees C)
- Weight >=110 pounds
- Adequate bilateral antecubital venous access
- Hemoglobin >= 12.5 g/dL for women; >= 13.0 g/dL for men within 56 days prior to apheresis procedure.
- Platelets > 150,000 K/uL within 56 days prior to apheresis procedure.
- 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
- No current lung or kidney disease
- No known coagulation disorder
- No sickle cell disease
- No active or chronic hepatitis
- No intravenous injection drug use in the past 5 years
- Not breast feeding
- 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
- Patients with an Infectious Disease:
- A patient with an infectious disease must meet all the following criteria:
- Age 18 years or older
- Weight >= 110 pounds
- Afebrile (temperature <= 37.5 degrees C)
- Adequate bilateral antecubital venous access
- 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)
- No current lung or kidney disease
- No known coagulation disorder
- No receipt of clotting factor concentrates in the past 5 years
- Hemoglobin >= 9.0 g/dL within 56 days prior to apheresis procedure
- Platelets >= 50,000 K/uL within 56 days prior to apheresis procedure
- White Blood Cell (WBC) >= 2.0 K/uL within 56 days prior to apheresis procedure
- Not breast feeding
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
VRC Clinic, 301-451-8715, vaccines@nih.gov
- Completed
EvergreenHealth Medical Center
Kirkland, Washington, 98034
Puerto Rico1 site
- Active, not recruiting
University of Puerto Rico Medical Sciences Campus
San Juan, 00921
About this study
Official title: 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 participant 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.
Read more
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.
Read the detailed description
Study Description:
This protocol is designed to collect human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or body fluids to support medical research. These samples will be used by researchers, in their work on the development of vaccines and monoclonal antibodies, to study the correlates of immunity related to infectious diseases and allergies, and in laboratory work related to the development and/or validation of immunological and other relevant assays. Standard phlebotomy and apheresis procedures will be utilized to safely obtain necessary quantities of blood and cells.
Objectives:
To obtain human biological specimens such as blood (via phlebotomy), plasma or peripheral blood mononuclear cells (PBMC) samples (via apheresis), mucosal secretions, skin swabs, body fluids, and skin biopsy to support medical research.
Endpoints:
There are no specific endpoints in this study, as samples are collected for investigations conducted in research laboratories to address questions related to immunity and vaccine and monoclonal antibody development. Therefore, 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 a participant identification number. Non-personally identifying information that will be linked to a participant ID only, such as demographic information, aspects of the 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.
- Conditions
- Sample Collection
- Keywords
- Volunteer, Plasmapheresis, Leukapheresis, Immunology, Leukocyte, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sample collection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample collection only
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. Participant 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.
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2003 (estimated)
- Study start10 Sep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sample CollectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lesia K Dropulic, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067054
- Sponsor's protocol ID
- 030263
- Other IDs
- 03-I-0263
- Status last verified
- 24 Sep 2026
- First submitted
- 8 Aug 2003
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Strauss RG, Maguire LC, Koepke JA, Thompson JS. Effect of intermittent-flow centrifugation leukapheresis on donor leukocyte counts. Acta Haematol. 1980;63(3):128-31. doi: 10.1159/000207383.
PubMed 6769278Heal JM, Horan PK, Schmitt TC, Bailey G, Nusbacher J. Long-term follow-up of donors cytapheresed more than 50 times. Vox Sang. 1983;45(1):14-24. doi: 10.1111/j.1423-0410.1983.tb04118.x.
PubMed 6410585Braine HG, Elfenbein GJ, Mellits ED. Peripheral blood lymphocyte numbers, lymphocyte proliferative responses in vitro, and serum immunoglobulins in regular hemapheresis donors. J Clin Apher. 1985;2(3):213-8. doi: 10.1002/jca.2920020302.
PubMed 4030708Zhou T, Teng IT, Olia AS, Cerutti G, Gorman J, Nazzari A, Shi W, Tsybovsky Y, Wang L, Wang S, Zhang B, Zhang Y, Katsamba PS, Petrova Y, Banach BB, Fahad AS, Liu L, Acevedo SNL, Madan B, de Souza MO, Pan X, Wang P, Wolfe JR, Yin M, Ho DD, Phung E, DiPiazza A, Chang L, Abiona O, Corbett KS, DeKosky BJ, Graham BS, Mascola JR, Misasi J, Ruckwardt T, Sullivan NJ, Shapiro L, Kwong PD. Structure-Based Design with Tag-Based Purification and In-Process Biotinylation Enable Streamlined Development of SARS-CoV-2 Spike Molecular Probes. SSRN [Preprint]. 2020 Jul 21:3639618. doi: 10.2139/ssrn.3639618.
PubMed 32742241
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 200: A Multicenter Specimen Collection Protocol to Obtain Human Biological Samples for Research Studies
- ClinicalTrials.gov ID
- NCT00067054
- Acronym / sponsor ID
- 030263
- Conditions
- Sample Collection
- Keywords
- Volunteer, Plasmapheresis, Leukapheresis, Immunology, Leukocyte, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 10 Sep 2003 (actual)
- First posted
- 11 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 participant 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.
Detailed description
Study Description:
This protocol is designed to collect human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or body fluids to support medical research. These samples will be used by researchers, in their work on the development of vaccines and monoclonal antibodies, to study the correlates of immunity related to infectious diseases and allergies, and in laboratory work related to the development and/or validation of immunological and other relevant assays. Standard phlebotomy and apheresis procedures will be utilized to safely obtain necessary quantities of blood and cells.
Objectives:
To obtain human biological specimens such as blood (via phlebotomy), plasma or peripheral blood mononuclear cells (PBMC) samples (via apheresis), mucosal secretions, skin swabs, body fluids, and skin biopsy to support medical research.
Endpoints:
There are no specific endpoints in this study, as samples are collected for investigations conducted in research laboratories to address questions related to immunity and vaccine and monoclonal antibody development. Therefore, 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 a participant identification number. Non-personally identifying information that will be linked to a participant ID only, such as demographic information, aspects of the 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Sample collection only |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants may be individuals participating solely in this protocol or may be individuals 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 participants from the community. Children are not eligible to participate in this clinical trial.
Key inclusion criteria (10 listed)
- Age 18 years or older
- Able and willing to complete the informed consent process
- Willing to provide blood or other samples that will be stored indefinitely and used for future research
- Able to provide proof of identity to the acceptance of the clinician completing the enrollment process; when informed consent is obtained by telephone or a telehealth visit, the investigator obtaining consent will also confirm proof of identity.
- Children aged 3 to 17 years inclusive, and at least 12 kg in weight.
Key exclusion criteria (45 listed)
- A participant 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.
- Acute or chronic illness that, in the opinion of the investigator or designee, precludes participation in the study.
- Factors related to the legal guardian that, in the judgment of the investigator or designee, may affect the objective decision-making of the legal guardian.
- Age 18 years or older
- No known allergies to the local anesthetic to be used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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. Participant 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 6769278Strauss RG, Maguire LC, Koepke JA, Thompson JS. Effect of intermittent-flow centrifugation leukapheresis on donor leukocyte counts. Acta Haematol. 1980;63(3):128-31. doi: 10.1159/000207383.
- Background: PubMed 6410585Heal JM, Horan PK, Schmitt TC, Bailey G, Nusbacher J. Long-term follow-up of donors cytapheresed more than 50 times. Vox Sang. 1983;45(1):14-24. doi: 10.1111/j.1423-0410.1983.tb04118.x.
- Background: PubMed 4030708Braine HG, Elfenbein GJ, Mellits ED. Peripheral blood lymphocyte numbers, lymphocyte proliferative responses in vitro, and serum immunoglobulins in regular hemapheresis donors. J Clin Apher. 1985;2(3):213-8. doi: 10.1002/jca.2920020302.
- Derived from this study: PubMed 32742241Zhou T, Teng IT, Olia AS, Cerutti G, Gorman J, Nazzari A, Shi W, Tsybovsky Y, Wang L, Wang S, Zhang B, Zhang Y, Katsamba PS, Petrova Y, Banach BB, Fahad AS, Liu L, Acevedo SNL, Madan B, de Souza MO, Pan X, Wang P, Wolfe JR, Yin M, Ho DD, Phung E, DiPiazza A, Chang L, Abiona O, Corbett KS, DeKosky BJ, Graham BS, Mascola JR, Misasi J, Ruckwardt T, Sullivan NJ, Shapiro L, Kwong PD. Structure-Based Design with Tag-Based Purification and In-Process Biotinylation Enable Streamlined Development of SARS-CoV-2 Spike Molecular Probes. SSRN [Preprint]. 2020 Jul 21:3639618. doi: 10.2139/ssrn.3639618.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Sample Collection
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
Prostate Cancer
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lesia K Dropulic, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sample Collection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OPS Team, VRC (Not Listed, vaccines@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sample collection only (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067054, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.