Sample Collection
Conditions
Keywords
Volunteer, Plasmapheresis, Leukapheresis, Immunology, Leukocyte, Natural History
Brief summary
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 participant 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....
Detailed description
Study Description: This protocol is designed to collect human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or body fluids to support medical research. These samples will be used by researchers, in their work on the development of vaccines and monoclonal antibodies, to study the correlates of immunity related to infectious diseases and allergies, and in laboratory work related to the development and/or validation of immunological and other relevant assays. Standard phlebotomy and apheresis procedures will be utilized to safely obtain necessary quantities of blood and cells. Objectives: To obtain human biological specimens such as blood (via phlebotomy), plasma or peripheral blood mononuclear cells (PBMC) samples (via apheresis), mucosal secretions, skin swabs, body fluids, and skin biopsy to support medical research. Endpoints: There are no specific endpoints in this study, as samples are collected for investigations conducted in research laboratories to address questions related to immunity and vaccine and monoclonal antibody development. Therefore, 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 a participant identification number. Non-personally identifying information that will be linked to a participant ID only, such as demographic information, aspects of the medical history, laboratory parameters, recent immunizations or medications, genetic tests, and other medical information, may be provided to researchers if needed to support the objectives of the laboratory research.
Interventions
None listed
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* INCLUSION CRITERIA FOR ADULT PARTICIPANTS: A participant must meet all 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 indefinitely and used for future research 4. Able to provide proof of identity to the acceptance of the clinician completing the enrollment process; when informed consent is obtained by telephone or a telehealth visit, the investigator obtaining consent will also confirm proof of identity. INCLUSION CRITERIA FOR CHILDREN: 1. Children aged 3 to 17 years inclusive, and at least 12 kg in weight. 2. Capability of the legal adult guardian of the child to understand and comply with the planned study procedures. 3. Capability of the legal adult guardian of the child to provide written informed consent. 4. Willing to have blood drawn or collection of urine, fecal samples, oral secretions, or swabs of mucosa that will be stored indefinitely and used for future research. 5. The legal adult guardian of the children can provide proof of identity for the child and for themselves to the satisfaction of the clinician completing the enrollment process.
Exclusion criteria
FOR ALL PARTICIPANTS: A participant 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sample collection only | end of study | This protocol does not have an analysis primary outcome measure, but rather 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. Participant 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. |
Countries
Puerto Rico, United States
Contacts
CONTACTOPS Team, VRC
PRINCIPAL_INVESTIGATORLesia K Dropulic, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Outcome results
None listed