VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
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| ClinicalTrials.gov Identifier: NCT01132859 |
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Recruitment Status :
Recruiting
First Posted : May 28, 2010
Last Update Posted : June 14, 2018
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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.
| Condition or disease |
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| Immune System |
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 blood, body fluids, mucosal and tissue samples, radiographic imaging and clinical evaluations. 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 donate specimens for research purposes will be enrolled. Participants must 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 Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older |
| Study Start Date : | May 7, 2010 |
- To evaluate blood and other tissue samples for immune responses to vacciness and natural infections. [ Time Frame: As indicated for evaluation of immune responses to particular infection and/or vaccination regimen ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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INCLUSION CRITERIA:
18 years of age or older.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Able and willing to complete the informed consent process.
Willing to donate specimens for storage to be used for research and to have genetic tests performed for research purposes.
EXCLUSION CRITERIA:
Any medical, psychiatric, occupational condition or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject s ability to give informed consent.
Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), use of anticoagulant medications for an ongoing medical condition, significant bruising or bleeding difficulties with IM injections or blood draws. [Note: Subjects taking anticoagulants, such as aspirin, prophylactically may be considered on a case to case basis.]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132859
| Contact: Pamela Costner, R.N. | (301) 451-8715 | vaccines@nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: VRC Clinic 301-451-8715 vaccines@nih.gov | |
| Principal Investigator: | Michelle C Crank, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT01132859 History of Changes |
| Other Study ID Numbers: |
100109 10-I-0109 |
| First Posted: | May 28, 2010 Key Record Dates |
| Last Update Posted: | June 14, 2018 |
| Last Verified: | August 17, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC):
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Specimen Collection Mucosal Immunity Immune Responses Immunity |
Vaccines Healthy Volunteer HV |