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Trial record 42 of 64 for:    lyme

CD8 Reactivity to Microorganisms in Blood and Breast Milk

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ClinicalTrials.gov Identifier: NCT03084614
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : July 14, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


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.


To learn more about how the human body fights off infections.


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.


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.

Condition or disease
Tuberculosis Leprosy Pertussis Lyme Disease

Detailed Description:

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.

Study Design

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CD8 Reactivity to Microorganisms in Blood and Breast Milk
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : February 27, 2019
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group A
Adults with atopic dermatitis
Group B
Pediatrics with atopic dermatitis

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with atopic dermatitis age 7 and up.


  1. Age 18+ years.
  2. Willing to allow storage of blood, breast milk, and cells for future research.
  3. Willing to have genetic testing performed.
  4. Meets one of the 3 following criteria:

    1. Confirmed exposure:

      -Exposure has been verifiably documented (eg, receiving an immunization or DNCB sensitization treatment).


      -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).


      -Positive results on established clinical immunity tests (eg, viral RNA, antibody titers, etc).

    2. Suspected exposure: Clinical history is consistent with established epidemiology of the microbe of interest (eg, travel to endemic areas, documentation of past infection) but no established clinical assay exists to verify exposure.
    3. Non-exposed: Absence of exposure to targeted microorganisms as measured by lack of exposure to infected individuals, lack of travel to endemic areas, no immunization history, negative screening tests, or other methods of establishing exposure history to mucosal microbial agents.


  1. Active use of immunosuppressive medications.
  2. Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084614

Contact: Ian A Myles, M.D. (301) 451-8420 mylesi@niaid.nih.gov

United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Ian A Myles, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03084614     History of Changes
Other Study ID Numbers: 170068
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 12, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Infectious Diseases
Dendritic Cells
Passive Cellular Immunity

Additional relevant MeSH terms:
Lyme Disease
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Borrelia Infections
Gram-Negative Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections