CD8 Reactivity to Microorganisms in Blood and Breast Milk

NCT03084614 | Terminated

• 2 other identifiers: 17006817-I-0068
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immune Modulation; Tuberculosis; Leprosy; Pertussis; Lyme Disease

Keywords

Infectious Diseases; Dendritic Cells; Pathogens; Passive Cellular Immunity

Outcome Measures

Primary Outcomes (1)

• To compare the in vitro and mouse model immune stimulatoryproperties of lysates derived from microbe-specific CDB+ T cellenriched sources.

  There are no definitive time points in this sample collection study

Secondary Outcomes (1)

• To compare how the in vitro and mouse model immune stimulatoryproperties of breast milk vary with the microbe specific CDB+ T cellconcentration.

  There are no definitive time points in this sample collection study

Study Arms (2)

Controls

non exposed controls

donors with naturally enriched antimicrobial blood samples and

Donors with naturally enriched antimicrobial blood samples an breast milk, Comparisons will be made with non exposed controls.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

clinical center patients, family members, healthy controls

You may qualify if:

• Age 18+ years.
• Willing to allow storage of blood, breast milk, and cells for future research.
• Willing to have genetic testing performed.
• Meets one of the 3 following criteria:
• 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).
• AND
• Positive results on established clinical immunity tests (eg, viral RNA, antibody titers, etc).
• 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.
• 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.

You may not qualify if:

• Active use of immunosuppressive medications.
• Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Myles IA, Zhao M, Nardone G, Olano LR, Reckhow JD, Saleem D, Break TJ, Lionakis MS, Myers TG, Gardina PJ, Kirkpatrick CH, Holland SM, Datta SK. CD8+ T cells produce a dialyzable antigen-specific activator of dendritic cells. J Leukoc Biol. 2017 Jan;101(1):307-320. doi: 10.1189/jlb.3A0216-082R. Epub 2016 Aug 11.

  PMID: 27515950 BACKGROUND

• Viza D, Fudenberg HH, Palareti A, Ablashi D, De Vinci C, Pizza G. Transfer factor: an overlooked potential for the prevention and treatment of infectious diseases. Folia Biol (Praha). 2013;59(2):53-67. doi: 10.14712/fb2013059020053.

  PMID: 23746171 BACKGROUND

• Chahroudi A, Cartwright E, Lee ST, Mavigner M, Carnathan DG, Lawson B, Carnathan PM, Hashempoor T, Murphy MK, Meeker T, Ehnert S, Souder C, Else JG, Cohen J, Collman RG, Vanderford TH, Permar SR, Derdeyn CA, Villinger F, Silvestri G. Target cell availability, rather than breast milk factors, dictates mother-to-infant transmission of SIV in sooty mangabeys and rhesus macaques. PLoS Pathog. 2014 Mar 6;10(3):e1003958. doi: 10.1371/journal.ppat.1003958. eCollection 2014 Mar.

  PMID: 24604066 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Leprosy; Whooping Cough; Lyme Disease; Communicable Diseases

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Mycobacterium Infections, Nontuberculous; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian A Myles, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 21, 2017
• Study Start: March 28, 2017
• Primary Completion: February 16, 2018
• Study Completion: November 8, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

US (1)