Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 5:10 PM
Study NCT ID:
NCT01132859
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2010-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
Status:
RECRUITING
Status Verified Date:
2025-11-19
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:
Background:
\- The Vaccine Research Center (VRC) is dedicated to understanding immune responses associated with prevention and treatment of infectious diseases. To study these immune responses, researchers need to collect specimens and images from individuals who have recently had a vaccination or recovered from an infection. These specimens and images are used to study different diseases and immune responses, and can be used to investigate ways to prevent or treat different medical conditions.
Objectives:
\- To evaluate blood and other tissue samples for immune responses to vaccines and natural infections.
Eligibility:
\- Healthy volunteers at least 18 years of age who agree to donate specimens for research purposes.
Design:
* Participants will have clinical evaluations and will be asked to provide some of the following samples, depending on the research question being addressed. All procedures and sample donations are optional and voluntary:
* Blood samples through regular blood draws (for whole blood) and apheresis (to collect specific parts of the blood such as plasma or white blood cells)
* Urine, semen, saliva, or vaginal swab samples
* Tissue samples or biopsy specimens
* Undergo procedures such as bronchoscopy (lung and respiratory tract), gastrointestinal endoscopy (stomach and upper intestinal tract), or colonoscopy (lower intestinal tract) to obtain tissue samples
* Undergo imaging studies such as positron emission tomography (PET) or computed tomography (CT) scans
Duration of participation is variable depending on the research question but will usually last up to 1 year.
\- Participants will be compensated for participation.
\- The Vaccine Research Center (VRC) is dedicated to understanding immune responses associated with prevention and treatment of infectious diseases. To study these immune responses, researchers need to collect specimens and images from individuals who have recently had a vaccination or recovered from an infection. These specimens and images are used to study different diseases and immune responses, and can be used to investigate ways to prevent or treat different medical conditions.
Objectives:
\- To evaluate blood and other tissue samples for immune responses to vaccines and natural infections.
Eligibility:
\- Healthy volunteers at least 18 years of age who agree to donate specimens for research purposes.
Design:
* Participants will have clinical evaluations and will be asked to provide some of the following samples, depending on the research question being addressed. All procedures and sample donations are optional and voluntary:
* Blood samples through regular blood draws (for whole blood) and apheresis (to collect specific parts of the blood such as plasma or white blood cells)
* Urine, semen, saliva, or vaginal swab samples
* Tissue samples or biopsy specimens
* Undergo procedures such as bronchoscopy (lung and respiratory tract), gastrointestinal endoscopy (stomach and upper intestinal tract), or colonoscopy (lower intestinal tract) to obtain tissue samples
* Undergo imaging studies such as positron emission tomography (PET) or computed tomography (CT) scans
Duration of participation is variable depending on the research question but will usually last up to 1 year.
\- Participants will be compensated for participation.
Detailed Description:
Protocol Design:
This is a specimen, imaging and data collection protocol designed with the purpose of understanding the immune responses to vaccines and infections in adult subjects through collection of tissue specimens and medical history data, and radiographic imaging. The information gained will enhance the knowledge of immune correlates of protection and will help in laboratory work related to the development and validation of immunological assays. This protocol will allow Vaccine Research Center (VRC) investigators and collaborators to evaluate tissue level immune responses in subjects who are recipients of Food and Drug Administration (FDA)-licensed vaccines, recipients of VRC clinical trials vaccines, control subjects, and naturally infected subjects as examples of naturally acquired immunity. Immune responses will be evaluated using collection of blood, body fluids, mucosal and tissue samples; conducting radiographic imaging; and performing clinical evaluations for research rather than therapeutic goals. The underlying hypothesis for this protocol is that detailed studies of immune responses in blood and a diversity of tissue types, including a variety of mucosal surfaces, will further the understanding of immune responses following vaccination or recovery from an infectious disease and will advance development of vaccines against existing, new, and re-emerging pathogens.
Subjects:
Volunteers 18 years of age and older who agree to collection, use, and storage of specimens and images for research purposes will be enrolled. Participants must not be pregnant or breast-feeding for certain study sample collection procedures. A maximum of 500 subjects will be enrolled in the protocol.
Study Plan:
Subjects will receive information about study procedures and, if willing to participate, will sign the study informed consent. FDA-licensed vaccines may be administered to some study subjects as part of study participation. As per NIH Clinical Center (CC) policy, where appropriate, subjects will provide additional informed consent for study procedures.
Duration:
Individual subjects may donate samples as often as permitted by the protocol and NIH CC guidelines. The CC guidance on the volume of blood drawn and other inpatient/outpatient procedures will be followed. The protocol will undergo continuing review by the Institutional Review Board (IRB) annually.
This is a specimen, imaging and data collection protocol designed with the purpose of understanding the immune responses to vaccines and infections in adult subjects through collection of tissue specimens and medical history data, and radiographic imaging. The information gained will enhance the knowledge of immune correlates of protection and will help in laboratory work related to the development and validation of immunological assays. This protocol will allow Vaccine Research Center (VRC) investigators and collaborators to evaluate tissue level immune responses in subjects who are recipients of Food and Drug Administration (FDA)-licensed vaccines, recipients of VRC clinical trials vaccines, control subjects, and naturally infected subjects as examples of naturally acquired immunity. Immune responses will be evaluated using collection of blood, body fluids, mucosal and tissue samples; conducting radiographic imaging; and performing clinical evaluations for research rather than therapeutic goals. The underlying hypothesis for this protocol is that detailed studies of immune responses in blood and a diversity of tissue types, including a variety of mucosal surfaces, will further the understanding of immune responses following vaccination or recovery from an infectious disease and will advance development of vaccines against existing, new, and re-emerging pathogens.
Subjects:
Volunteers 18 years of age and older who agree to collection, use, and storage of specimens and images for research purposes will be enrolled. Participants must not be pregnant or breast-feeding for certain study sample collection procedures. A maximum of 500 subjects will be enrolled in the protocol.
Study Plan:
Subjects will receive information about study procedures and, if willing to participate, will sign the study informed consent. FDA-licensed vaccines may be administered to some study subjects as part of study participation. As per NIH Clinical Center (CC) policy, where appropriate, subjects will provide additional informed consent for study procedures.
Duration:
Individual subjects may donate samples as often as permitted by the protocol and NIH CC guidelines. The CC guidance on the volume of blood drawn and other inpatient/outpatient procedures will be followed. The protocol will undergo continuing review by the Institutional Review Board (IRB) annually.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10-I-0109 | None | None | View |