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

NCT01132859 | Recruiting

• 2 other identifiers: 10010910-I-0109
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immunity, Mucosal; Immune System Processes; Blood Specimen Collection

Keywords

Specimen Collection; Mucosal Immunity; Immune Responses; Immunity; Vaccines; Natural History; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (3)

• To use specimens and accumulated data for enhancement of understanding the correlates of immune protection.

  By sample collection and imaging studies

  Throughout the study

• To evaluate blood, body fluid, and tissue immune responses and pathogen dynamics of naturally infected and antigen-na(SqrRoot) ve subjects

  By sample collection and imaging studies

  Throughout the study

• To evaluate innate, humoral, and cellular immune responses and pathogen dynamics in the context of vaccination in the blood, body fluids, excretions, and tissues

  By sample collection and imaging studies

  Throughout the study

Study Arms (1)

1

Participants 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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants 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.

You may qualify if:

• 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.

You may not qualify if:

• Any medical, psychiatric, occupational condition or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant 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 intramuscular injections or blood draws. \[Note: Participants taking anticoagulants, such as aspirin, prophylactically may be considered on a case to case basis.\]

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (4)

• Querec TD, Akondy RS, Lee EK, Cao W, Nakaya HI, Teuwen D, Pirani A, Gernert K, Deng J, Marzolf B, Kennedy K, Wu H, Bennouna S, Oluoch H, Miller J, Vencio RZ, Mulligan M, Aderem A, Ahmed R, Pulendran B. Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans. Nat Immunol. 2009 Jan;10(1):116-125. doi: 10.1038/ni.1688. Epub 2008 Nov 23.

  PMID: 19029902 BACKGROUND

• Wrammert J, Miller J, Akondy R, Ahmed R. Human immune memory to yellow fever and smallpox vaccination. J Clin Immunol. 2009 Mar;29(2):151-7. doi: 10.1007/s10875-008-9267-3. Epub 2008 Dec 4.

  PMID: 19052852 BACKGROUND

• Plotkin SA. Vaccines: the fourth century. Clin Vaccine Immunol. 2009 Dec;16(12):1709-19. doi: 10.1128/CVI.00290-09. Epub 2009 Sep 30.

  PMID: 19793898 BACKGROUND

• Herrin DM, Coates EE, Costner PJ, Kemp TJ, Nason MC, Saharia KK, Pan Y, Sarwar UN, Holman L, Yamshchikov G, Koup RA, Pang YY, Seder RA, Schiller JT, Graham BS, Pinto LA, Ledgerwood JE. Comparison of adaptive and innate immune responses induced by licensed vaccines for Human Papillomavirus. Hum Vaccin Immunother. 2014;10(12):3446-54. doi: 10.4161/hv.34408.

  PMID: 25483691 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Lesia K Dropulic, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OPS Team, VRC

CONTACT

Not Listed; vrcops@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: May 18, 2010
• Last Updated: April 14, 2026

Record last verified: 2026-01-09

Locations

US (1)