Clinical trial NCT01132859: VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
Official title: VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immunity, Mucosal
Immune System Processes
Blood Specimen Collection
Keywords: Specimen Collection
Mucosal Immunity
Immune Responses
Immunity
Vaccines
Natural History
Healthy Volunteer
HV
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2010-05-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.@@@

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.

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 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.

Eligibility 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. \[Note: Subjects taking anticoagulants, such as aspirin, prophylactically may be considered on a case to case basis.\]

Primary outcomes:
measure: To use specimens and accumulated data for enhancement of understanding the correlates of immune protection.
timeFrame: Throughout the study
measure: To evaluate blood, body fluid, and tissue immune responses and pathogen dynamics of naturally infected and antigen-na(SqrRoot) ve subjects
timeFrame: Throughout the study
measure: To evaluate innate, humoral, and cellular immune responses and pathogen dynamics in the context of vaccination in the blood, body fluids, excretions, and tissues
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Lesia K Dropulic, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.