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

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Enrolling

Conditions: Immune System Processes; Immunity, Mucosal; Blood Specimen Collection

Study type: Observational

Funder types: NIH

Identifiers

NCT01132859

100109

10-I-0109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.]

Trial design

500 participants in 1 patient group

1

Description:

Volunteers of 18 years of age or older willing to donate blood and tissue specimens and participate in imaging studies to evaluate the components of the immune system