Staphylococcal InfectionsNCT06479837
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
An observational study of Staphylococcal Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 120 years
- Conditions the study is for
- Staphylococcal Infections
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Oct 2026to 1 Dec 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the detailed description
STUDY DESCRIPTION:
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
- Staphylococcal Infections
- Keywords
- Organoid, Staphylococcus, Host-pathogen Interactions
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tonsillectomy Patients | Patients undergoing tonsillectomy as part of their clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of collection
Secondary outcomes (5)
Immune cell composition
Primary signals such as antigen characteristics, and secondary signals such as cytokines have been implicated in class switching to IgG4 but have not been defined with respect to CHIPS. Varying these signals and evaluating: 1) organoid immune cell composition, 2) antibody and 3) cytokines levels, and indicators of class switching such as 4) AID and 5) sciCSR levels, will enable us to evaluate modulation of human immunotolerance to CHIPS.
Measured: At time of collection
Anti-CHIPS antibody levels, including total and subclasses of IgG and their neutralizing capacity
Primary signals such as antigen characteristics, and secondary signals such as cytokines have been implicated in class switching to IgG4 but have not been defined with respect to CHIPS. Varying these signals and evaluating: 1) organoid immune cell composition, 2) antibody and 3) cytokines levels, and indicators of class switching such as 4) AID and 5) sciCSR levels, will enable us to evaluate modulation of human immunotolerance to CHIPS.
Measured: At time of collection
Cytokine levels
Primary signals such as antigen characteristics, and secondary signals such as cytokines have been implicated in class switching to IgG4 but have not been defined with respect to CHIPS. Varying these signals and evaluating: 1) organoid immune cell composition, 2) antibody and 3) cytokines levels, and indicators of class switching such as 4) AID and 5) sciCSR levels, will enable us to evaluate modulation of human immunotolerance to CHIPS.
Measured: At time of collection
Activation-induced cytidine deaminase (AID) levels
Primary signals such as antigen characteristics, and secondary signals such as cytokines have been implicated in class switching to IgG4 but have not been defined with respect to CHIPS. Varying these signals and evaluating: 1) organoid immune cell composition, 2) antibody and 3) cytokines levels, and indicators of class switching such as 4) AID and 5) sciCSR levels, will enable us to evaluate modulation of human immunotolerance to CHIPS.
Measured: At time of collection
Single-cell inference of class switch recombination (sciCSR)
Primary signals such as antigen characteristics, and secondary signals such as cytokines have been implicated in class switching to IgG4 but have not been defined with respect to CHIPS. Varying these signals and evaluating: 1) organoid immune cell composition, 2) antibody and 3) cytokines levels, and indicators of class switching such as 4) AID and 5) sciCSR levels, will enable us to evaluate modulation of human immunotolerance to CHIPS.
Measured: At time of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start29 Oct 2026 (estimated)
- Primary completion1 Dec 2043 (estimated)
- Study completion1 Dec 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael Otto, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479837
- Sponsor's protocol ID
- 10002062
- Other IDs
- 002062-I
- Status last verified
- 2 Dec 2025
- First submitted
- 27 Jun 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Experiments will be conducted in groups of 5 to 16 organoids and will be reported according to experimental groups. Participant data will not be reported individually.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Host-Pathogen Interaction Using Lymphoid Organoids
- ClinicalTrials.gov ID
- NCT06479837
- Acronym / sponsor ID
- 10002062
- Conditions
- Staphylococcal Infections
- Keywords
- Organoid, Staphylococcus, Host-pathogen Interactions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2043 (estimated)
- Study completion
- 1 Dec 2044 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY DESCRIPTION:
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tonsillectomy Patients | – | –Patients undergoing tonsillectomy as part of their clinical care |
Who may qualify
- Ages
- 2 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immune cell composition
Time frame: At time of collection
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.
Anti-CHIPS antibody levels, including total and subclasses of IgG and their neutralizing capacity
Time frame: At time of collection
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.
Cytokine levels
Time frame: At time of collection
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.
Activation-induced cytidine deaminase (AID) levels
Time frame: At time of collection
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.
Single-cell inference of class switch recombination (sciCSR)
Time frame: At time of collection
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.
5 secondary outcomes
Immune cell composition
Time frame: At time of collection
Anti-CHIPS antibody levels, including total and subclasses of IgG and their neutralizing capacity
Time frame: At time of collection
Cytokine levels
Time frame: At time of collection
Activation-induced cytidine deaminase (AID) levels
Time frame: At time of collection
Single-cell inference of class switch recombination (sciCSR)
Time frame: At time of collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Experiments will be conducted in groups of 5 to 16 organoids and will be reported according to experimental groups. Participant data will not be reported individually.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Otto, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcal Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Le, M.D. ((301) 761-7166, katherine.le@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune cell composition (time frame: At time of collection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.