Modeling Host-Pathogen Interaction Using Lymphoid Organoids

NCT06479837 | Recruiting

• 2 other identifiers: 10002062002062-I
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Staphylococcus aureus (S.aureus) are bacteria that can make people sick. Sometimes, an S. aureus infection can develop inside the spine; these infections can lead to paralysis and death. Researchers do not know how S. aureus interacts with a person s cells to cause infections in the spine. Objective: To learn how S. aureus interacts with cells in the body using tissues from tonsils discarded after standard surgery to remove them. Eligibility: People aged 2 years and older who are scheduled to have their tonsils removed. Design: Researchers will select participants for the study based on review of their existing medical records, including results of blood tests; any imaging scans, including x-rays; and reports about tissue specimens. Participants will answer questionnaires about their health and past infections. They can do this online or on paper. Participants will collect a nasal swab 1 week before their surgery. They will be given a tool that looks like a long cotton swab. They will twirl it around inside their nose. The swab will pick up cells and fluids that will be used for research. After their surgery, the participant s surgeon will save samples of tonsil tissue. The surgeon will send these tissue samples and the nasal swab to researchers at the NIH. These tissues and the swab will be used in studies to help researchers understand how S. aureus interacts with cells in the body. They hope these studies will help them find better ways to treat S. aureus infections.

Conditions

Staphylococcal Infections

Keywords

Organoid; Staphylococcus; Host-pathogen Interactions

Outcome Measures

Primary Outcomes (5)

• Immune cell composition

  Develop a lymphoid organoid model from discarded human tonsils and determine and compare the human immunologic signatures of primary exposure, within the "antigenic sin" contexts of re-exposure, and with repeated exposures to CHIPS.

  At time of collection

• Anti-CHIPS antibody levels, including total and subclasses of IgG and their neutralizing capacity

  Develop a lymphoid organoid model from discarded human tonsils and determine and compare the human immunologic signatures of primary exposure, within the "antigenic sin" contexts of re-exposure, and with repeated exposures to CHIPS.

  At time of collection

• Cytokine levels

  Develop a lymphoid organoid model from discarded human tonsils and determine and compare the human immunologic signatures of primary exposure, within the "antigenic sin" contexts of re-exposure, and with repeated exposures to CHIPS.

  At time of collection

• Activation-induced cytidine deaminase (AID) levels

  Develop a lymphoid organoid model from discarded human tonsils and determine and compare the human immunologic signatures of primary exposure, within the "antigenic sin" contexts of re-exposure, and with repeated exposures to CHIPS.

  At time of collection

• Single-cell inference of class switch recombination (sciCSR)

  Develop a lymphoid organoid model from discarded human tonsils and determine and compare the human immunologic signatures of primary exposure, within the "antigenic sin" contexts of re-exposure, and with repeated exposures to CHIPS.

  At time of collection

Secondary Outcomes (5)

• Immune cell composition

  At time of collection

• Anti-CHIPS antibody levels, including total and subclasses of IgG and their neutralizing capacity

  At time of collection

• Cytokine levels

  At time of collection

• Activation-induced cytidine deaminase (AID) levels

  At time of collection

• Single-cell inference of class switch recombination (sciCSR)

  At time of collection

Study Arms (1)

Tonsillectomy Patients

Patients undergoing tonsillectomy as part of their clinical care

Eligibility Criteria

• Age: 2 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing tonsillectomy as part of their clinical care at hospitals and pediatric ear nose and throat (ENT) practices in the US will be enrolled.

You may qualify if:

• To be eligible to participate in this study, an individual must meet all of the following criteria:
• Aged \>=2 yrs.
• Undergoing tonsillectomy as part of their clinical care.
• Able to provide informed consent (for ages \>=18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \<18 yrs).
• Willing to allow samples and data to be stored and shared for future secondary research.
• Willing to allow future genetic testing on their biospecimens.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Active infection.
• Active tonsilitis.
• Pregnant.
• Diagnosed with an immunosuppressive condition or currently taking immunosuppressive medications.
• Current or past intravenous drug use.
• Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study

Sponsors & Collaborators

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

Study Sites (2)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Michael Otto, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Le, M.D.

CONTACT

(301) 761-7166; katherine.le@nih.gov

Michael Otto, M.D.

CONTACT

(406) 363-9394; mo112y@nih.gov

Study Design

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

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: June 28, 2024
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): December 1, 2043
• Study Completion (Estimated): December 1, 2044
• Last Updated: May 6, 2026

Record last verified: 2025-12-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)