Protocol Details
VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
This study is currently recruiting participants.
Summary
Number |
10-I-0109 |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Keywords |
Specimen Collection;
Mucosal Immunity;
Immune Responses;
Immunity;
Vaccines;
Natural History |
Recruitment Keyword(s) |
Healthy Volunteer;
HV |
Condition(s) |
Immunity, mucosal;
immune system processes;
blood specimen collection |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Allergy and Infectious Diseases |
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.
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.]
Citations:
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):116-25. Epub 2008 Nov 23.
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. Epub 2008 Dec 4
Plotkin SA. Vaccines: the fourth century. Clin Vaccine Immunol. 2009 Dec;16(12):1709-19. Epub 2009 Sep 30.
Contacts:
Clinical Trials Number:
NCT01132859