Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067054
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2003-08-08
Brief Title:
Apheresis and Specimen Collection Procedures to Obtain Plasma Peripheral Blood Mononuclear Cells PBMCs and Other Specimens for Research Studies
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
VRC 200 A Multicenter Specimen Collection Protocol to Obtain Human Biological Samples for Research Studies
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study collects specimens from volunteers for use in studies by NIAIDs 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 individuals enrollment is for a 1-year period which can be extended
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 individuals 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 andor 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
Study Population
Adults ages 18 years and older
Protocol Plan
Subjects including healthy volunteers and patients with an infection or with an allergic or autoimmune condition who consent to participate in this study will undergo standard medical procedures to obtain biological specimens Samples may be collected at clinic visits by study staff or at home by the participant and shipped to the NIH by the participant
Study 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
Endpoints
There are no specific endpoints in this study as samples are collected for investigations conducted in research laboratories to address questions related to vaccine and monoclonal antibody development as noted in the study description 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 subject identification number Non-personally identifying information that will be linked to a subject 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
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 andor 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
Study Population
Adults ages 18 years and older
Protocol Plan
Subjects including healthy volunteers and patients with an infection or with an allergic or autoimmune condition who consent to participate in this study will undergo standard medical procedures to obtain biological specimens Samples may be collected at clinic visits by study staff or at home by the participant and shipped to the NIH by the participant
Study 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
Endpoints
There are no specific endpoints in this study as samples are collected for investigations conducted in research laboratories to address questions related to vaccine and monoclonal antibody development as noted in the study description 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 subject identification number Non-personally identifying information that will be linked to a subject 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-I-0263 | None | None | None |