Blood Specimen Collection Clinical Trial
Official title:
VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
NCT number | NCT01132859 |
Other study ID # | 100109 |
Secondary ID | 10-I-0109 |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 18, 2010 |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | - 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.] |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
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National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To use specimens and accumulated data for enhancement of understanding the correlates of immune protection. | By sample collection and imaging studies | Throughout the study | |
Primary | 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 | |
Primary | 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 |
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