NCT01132859

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

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.

Detailed description

Protocol Design: This is a specimen and data collection protocol designed with the research purpose of understanding the immune responses to vaccines and infections in adult participants. 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 participants who are recipients of Food and Drug Administration (FDA)-licensed vaccines, recipients of investigational vaccines, control subjects, and participants naturally infected with infectious diseases as examples of naturally acquired immunity. Immune responses will be evaluated using collection of blood, body fluids, mucosal and tissue samples to perform clinical evaluations for research rather than therapeutic goals. Imaging using ultrasonography may be employed to image tissues such as lymph nodes to guide sampling. Detailed studies of immune responses in blood, body fluids 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: Up to 500 participants 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 or to receive FDA-licensed live virus vaccines. Study Plan: Participants 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 participants as part of study participation. As per NIH Clinical Center (CC) policy, where appropriate, participants will provide additional informed consent for study procedures. Duration: Individual participants 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.

Conditions

• Immunity, Mucosal
• Immune System Processes
• Blood Specimen Collection

Timeline

• Start date: 2010-05-18
• First posted: 2010-05-28
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States