Bethesda, Maryland 20892


Purpose:

This study collects specimens from volunteers for use in studies by NIAID's Vaccine Research Center. A number of different types of specimens or samples can be collected, including blood, urine, body fluids or secretions, skin swabs, or skin biopsies. The samples are used for medical research, including the study of HIV, hepatitis, and other diseases; immune system responses, such as responses to vaccinations or infections; and for research on vaccine development. Blood samples may be collected either by ordinary blood drawing (phlebotomy) or by apheresis, a procedure for collecting a larger quantity of blood cells or plasma than would be possible through simple blood drawing. For this procedure, the subject lies on a recliner or couch. Blood is removed through a needle in the vein of one arm and spun in a machine that separates out the desired component (plasma or white blood cells). The remainder of the blood is returned either through the same needle or through a needle in the other arm. The procedure takes about 1 to 3 hours. Volunteers who are 18 years of age and older, including participants in other NIH research protocols, may be eligible. Individuals who have a condition that the research staff considers a reason not to make a sample donation will be excluded from the study. Participants may have only one sample collected or may be asked to undergo repetitive sample collection procedures, depending upon the requirements of the particular research project for which the samples are being collected. Each individual's enrollment is for a 1-year period, which can be extended.


Study summary:

Protocol Design: This protocol is designed to perform collection of human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or body fluids to support research studies. These samples will be used by laboratory researches in their work on the development of vaccines, to study the correlates of immunity related to infectious diseases and in laboratory work related to the development and/or validation of immunological assays. Standard phlebotomy and apheresis procedures will be utilized to safely obtain necessary quantities of blood and cells. Subjects: Adults ages 18 years and older Protocol Plan: Subjects who consent to participate will undergo standard medical procedures to obtain biological specimens. The signed informed consent is valid for one year; at least once per year, the subject must re-consent and eligibility should be re-confirmed Duration: Individual subjects may donate samples as often as permitted by their institution s guidelines. The IRB-approved protocol will remain open and undergo annual continuing review by the IRB as long as there continues to be a need for human biological specimens for research studies Endpoints: There is no analysis plan for this protocol. This protocol will be conducted in accordance with Good Clinical Practices for human research solely for the purpose of obtaining samples for research laboratories. Samples will be identified only by protocol identification number. Subject data, such as demographic information, aspects of medical history, laboratory parameters, recent immunizations or medications, HLA type, genetic tests and other medical information may be provided (identified by study number, but not subject name) to researchers if needed to support the objectives of the laboratory research..


Criteria:

- INCLUSION CRITERIA: A volunteer must meet all of the inclusion criteria, as follows: 1. Age 18 years or older. 2. Able and willing to complete the informed consent process. 3. Willing to provide blood or other samples that will be stored for future research. 4. Able to provide proof of identity to the acceptance of the clinician completing the enrollment process: when the telephone consent process is used, the clinician performing the sample collection will review the proof of identity. EXCLUSION CRITERIA: A subject will be excluded from protocol participation if there is presence of a condition that the attending physician considers to be a contraindication to the specimen collection procedures


NCT ID:

NCT00067054


Primary Contact:

Principal Investigator
Grace L Chen, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)

Ingelise Gordon, R.N.
Phone: (301) 451-8715
Email: vaccines@nih.gov


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

VRC Clinic
Phone: 301-451-8715
Email: vaccines@nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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