VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | May 7, 2010 |
| Contact: | Pamela Costner, R.N. |
| Email: | vaccines@nih.gov |
| Phone: | (301) 451-8715 |
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.
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.
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.
- 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.]
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 301-451-8715
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