Modeling Host-Pathogen Interaction Using Lymphoid Organoids
NCT ID: NCT06479837
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
500 participants
OBSERVATIONAL
2025-12-30
2044-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The purpose of this study is to collect tonsil tissues that are routinely discarded after tonsillectomy procedures to develop lymphoid organoid models to evaluate host-pathogen interactions in human health and disease. One such interaction is the human immunotolerance mechanism to the Chemotaxis Inhibitory Protein of S. aureus (CHIPS).
OBJECTIVES:
Primary Objectives:
-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.
Secondary Objective:
-Modulate anti-CHIPS IgG4 class switching through variation of primary and costimulatory signals.
ENDPOINTS:
Primary Endpoints:
Differences between the following within the "antigenic sin" contexts of re-exposure, and with repeated exposures to CHIPS:
* Immune cell composition.
* Anti-CHIPS antibody levels, including total and subclasses of IgG and their neutralizing capacity.
* Cytokine levels.
* Activation-induced cytidine deaminase (AID) levels.
* Single-cell inference of class switch recombination (sciCSR).
Secondary Endpoints:
Differences between the following modulation of primary and costimulatory signals:
* Immune cell composition.
* Anti-CHIPS antibody levels, including total and subclasses of IgG and their neutralizing capacity.
* Cytokine levels.
* AID levels.
* sciCSR
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tonsillectomy Patients
Patients undergoing tonsillectomy as part of their clinical care
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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.
Exclusion Criteria
* 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
2 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Otto, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
NIH Clinical Center Office of Patient Recruitment (OPR)
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
002062-I
Identifier Type: -
Identifier Source: secondary_id
10002062
Identifier Type: -
Identifier Source: org_study_id