VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older
|First Received Date ICMJE||May 27, 2010|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||May 6, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To evaluate blood and other tissue samples for immune responses to vacciness and natural infections. [ Time Frame: As indicated for evaluation of immune responses to particular infection and/or vaccination regimen ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01132859 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older|
|Official Title ICMJE||VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older|
- 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.
- To evaluate blood and other tissue samples for immune responses to vaccines and natural infections.
- Healthy volunteers at least 18 years of age who agree to donate specimens for research purposes.
Duration of participation is variable depending on the research question but will usually last up to 1 year.
- Participants will be compensated for participation.
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 blood, body fluids, mucosal and tissue samples, radiographic imaging and clinical evaluations. 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.
Volunteers 18 years of age and older who agree to donate specimens for research purposes will be enrolled. A maximum of 500 subjects will be enrolled in the protocol.
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Immune System|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
Pregnancy or breast feeding
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.]
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01132859|
|Other Study ID Numbers ICMJE||100109, 10-I-0109|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 14, 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP