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VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older

This study is currently recruiting participants.
Verified August 17, 2017 by National Institutes of Health Clinical Center (CC)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01132859
First Posted: May 28, 2010
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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
Immune System

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: May 7, 2010
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 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. 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.

  Eligibility

Information from the National Library of Medicine

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.]

  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Pamela Costner, R.N. (301) 451-8715 vaccines@nih.gov

Locations
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   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Michelle C Crank, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

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 Submitted: May 27, 2010
First Posted: May 28, 2010
Last Update Posted: October 19, 2017
Last Verified: August 17, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Specimen Collection
Mucosal Immunity
Immune Responses
Immunity
Vaccines
Healthy Volunteer
HV