An observational study in Immune Modulation, Tuberculosis and Leprosy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-11-14.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
Background:
When a person is exposed to something that causes an infection, the body sends a type of cell called CD8 T cells to attack it. Those cells are also found in breast milk. Nursing mothers pass these cells to their child, which helps the child fight infections, too. Researchers want to learn more about how CD8 cells work to keep people healthy.
Objective:
To learn more about how the human body fights off infections.
Eligibility:
People age 18 years and older who either have an infection, are suspected to have an infection, or recently got a vaccine.
The household contacts of these people and people who have not been recently exposed to any infection are also needed.
Design:
Participants will be screened with a medical and health history and physical exam. They may have blood tests.
The first study visit can be the same day as screening. It can be up to 3 months later. For those visits, screening tests will be repeated.
At the first visit, participants will have blood collected from an arm vein.
Participants who are breastfeeding may provide a small sample of breast milk. They may collect it at home or bring a pumping device to NIH to collect it. NIH can also provide a breast pump.
Participants may be contacted for up to 1 year after the first visit to give samples of blood and/or breast milk.
Up to 4 additional visits, which will each take about 1 hour, may be scheduled.
A personal physician or local lab can collect blood from participants and ship it to NIH. Breast milk cannot be shipped.
Cellular lysates from purified protein derivative-positive donors have been reported to transfer tuberculin reactivity to na(SqrRoot) ve recipients, but not diphtheria reactivity; similarly, cell lysates from diphtheria-reactive donors appear to transfer diphtheria reactivity without impacting responses to tuberculin. A historically controversial topic, the terms transfer factor and dialyzed leukocyte extract were used to characterize the reactivity-transferring properties of lysates. We found that the cellular extract derived from antigen-specific memory CD8+ T cells induces interleukin (IL)-6 from antigen-matched antigen-presenting cells. This ultimately elicits IL-17 from bystander memory CD8+ T cells. We identified that dialyzable peptide sequences, S100a9, and the TCR \<= chain from CD8+ T cells contribute to the molecular nature of this activity. We further showed that extracts from antigen-targeted T cells enhance immunity to Staphylococcus aureus and Candida albicans. The observed anti-Candida activity of lysates was enhanced when the cells were taken from individuals with higher-than-average exposure to Candida and correlated with increased numbers of Candida-reactive T-cells. These effects are sensitive to immunization protocols and extraction methodology in ways that may explain past discrepancies in the reproducibility of passive cellular immunity. Work by other groups has revealed that memory CD8+ T cells are also the only cell population enriched in breast milk as compared to an equal volume of peripheral blood. Taken together, it may be that the CD8+ memory T cells in breast milk serve as a mechanism of passive cellular immunity transference from mother to offspring. We thus aim to expand our analysis into the potential that lysates taken from sources with enriched immunity against a given microorganism will induce greater in vivo and mouse model activity compared to lysates from non-immune sources, and that this difference in lysate activity will be directly related to the CD8+ T cell enrichment.
In this study, we will collect blood and/or breast milk samples from donors with known or suspected exposure to pathogens, and also from healthy non-exposed volunteers. Research evaluations of samples will be done for the relevant microbe(s) of interest. The volume of blood taken from lacting mothers will be limited to 20mL or less per visit. Cells may be proliferated, immortalized, lysed and dialyzed, and/or stored. Cellular lysates will subsequently be used in both in vitro and pre-clinical animal models to assess for therapeutic potential.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 10 is below the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
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clinical center patients, family members, healthy controls
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meets one of the 3 following criteria:
Confirmed exposure:
-Exposure has been verifiably documented (eg, receiving an immunization or DNCB sensitization treatment).
OR
-Clinical history is consistent with established epidemiology of the microbe of interest (eg, documentation of past infection; or to a lesser priority travel to endemic areas or living with an individual that suffers from chronic infection with the targeted microbe).
AND
-Positive results on established clinical immunity tests (eg, viral RNA, antibody titers, etc).
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
non exposed controls
Donors with naturally enriched antimicrobial blood samples an breast milk, Comparisons will be made with non exposed controls.
To compare the in vitro and mouse model immune stimulatoryproperties of lysates derived from microbe-specific CDB+ T cellenriched sources.
Time frame: There are no definitive time points in this sample collection study
To compare how the in vitro and mouse model immune stimulatoryproperties of breast milk vary with the microbe specific CDB+ T cellconcentration.
Time frame: There are no definitive time points in this sample collection study
Ran from Mar 2017 to primary completion in Feb 2018, 10 months.
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This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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