ClinicalTrials.gg
Not yet recruitingNCT06120244Updated Nov 10, 2026

Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers

An observational study in Healthy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Updated Nov 10, 2026Start date movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 99 Years
Sex
All
01

Study summary

Background:

Infections in the lower respiratory tract (lungs) are the leading cause of death from infectious disease worldwide. This was true even before the COVID-19 pandemic. Respiratory viruses are still a major health threat. Many of these viruses infect people by penetrating the thin skin that lines the nose. These viruses can also spread easily to other people when they multiply in the tissues that line the nose. Researchers want to learn more about what these viruses do inside the nose, how they get from the nose to the lungs, and how they spread from person to person.

Objective:

To collect cell samples from inside the noses of healthy people. These cells will be stored for use in future research on respiratory diseases.

Eligibility:

Healthy volunteers aged 18 years and older.

Design:

Most participants will have 1 visit on 1 day. They will be asked questions. Those who have a runny nose, coughing, congestion, or fever will be asked to wait up to 21 days before participating.

Participants will be given a slender swab with small bristles at the end. They will rub the inside of their nose with the swab. A clinic staff member will be present to help, if needed.

Participants will provide their name, age, and sex. This information will be encoded so that only certain researchers will know the participants identities.

Participants will not be contacted again....

Read the detailed description

Study Description:

This is a repository protocol with prospective sample collection to provide samples needed for future studies of the pathogenesis of emerging respiratory viruses. Nasal brushings will be collected from approximately 100 healthy volunteers at RML and stored in the LV to be made available for future research studies that will be conducted under separate protocols, as applicable.

Primary Objective:

To obtain nasal epithelium brushes from healthy volunteers for 1) establishment of upper respiratory tract organoids, 2) assay validation, and 3) use for research into the pathogenesis of emerging respiratory viruses.

02

Conditions studied

  • Healthy

Keywords

  • Nasal Epithelium
03

In context

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy volunteers, aged 18 years and older, may be recruited from the general public, people working at and/or visiting Rocky Mountain Laboratories (RML), and NIH staff members and their family/contacts.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Aged >=18 years.
  • Able to provide .
  • Willing to allow biological samples and data to be stored for future research.

Exclusion criteria

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this

study:

  • History of respiratory symptoms including but not limited to runny nose, coughing, congestion, and/or fever within the past 14 days.
  • NIH and laboratory staff with direct involvement in the operation or maintenance of the repository are excluded from participation.
  • An individual who has any condition that, in the judgment of the investigator, may put them at undue risk or make them unsuitable for participation in the study will be excluded.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)

Groups and cohorts

  • Healthy Volunteers

    Healthy volunteers aged 18 years and older

06

What researchers measure

Primary outcomes

  1. To obtain nasal epithelium brushes from healthy volunteers for 1) establishment of upper respiratory tract organoids, 2) assay validation, and 3) use for research into the pathogenesis of emerging respiratory viruses.

    To obtain nasal epithelium brushes from healthy volunteers for 1) establishment of upper respiratory tract organoids, 2) assay validation, and 3) use for research into the pathogenesis of emerging respiratory viruses.

    Time frame: 10 years

07

Study locations

1 site
  • Rocky Mountain Laboratories
    Hamilton, Montana 59840, United States
08

References and documents

Publications

  • Rajan A, Weaver AM, Aloisio GM, Jelinski J, Johnson HL, Venable SF, McBride T, Aideyan L, Piedra FA, Ye X, Melicoff-Portillo E, Yerramilli MRK, Zeng XL, Mancini MA, Stossi F, Maresso AW, Kotkar SA, Estes MK, Blutt S, Avadhanula V, Piedra PA. The Human Nose Organoid Respiratory Virus Model: an Ex Vivo Human Challenge Model To Study Respiratory Syncytial Virus (RSV) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pathogenesis and Evaluate Therapeutics. mBio. 2021 Feb 22;13(1):e0351121. doi: 10.1128/mbio.03511-21. Epub 2022 Feb 15. PubMed 35164569 ↗
  • Stokes AB, Kieninger E, Schogler A, Kopf BS, Casaulta C, Geiser T, Regamey N, Alves MP. Comparison of three different brushing techniques to isolate and culture primary nasal epithelial cells from human subjects. Exp Lung Res. 2014 Sep;40(7):327-32. doi: 10.3109/01902148.2014.925987. Epub 2014 Jul 24. PubMed 25058379 ↗

Individual participant data

Plan to share: Yes — IPD underlying published data will be shared upon request after appropriate collaboration agreements are in place.

Supporting information: Study protocol

Time frame: At time of publication or establishment of collaboration agreement; IPD will be shared permanently.

Access criteria: Subject level data (sex and age of donor) may be shared as part of a scientific publication. Otherwise, subject level data will be shared upon request after appropriate collaboration agreements are in place.

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Updates

32 registry updates since Sep 25, 2026
Start date
Sep 29, 2026→Nov 15, 2026
moved 32 times, Sep 25, 2026 – Nov 10, 2026
Show all 32 updates
  1. Nov 10, 2026
    Start date Nov 12, 2026→Nov 15, 2026
  2. Nov 9, 2026
    Start date Nov 11, 2026→Nov 12, 2026
  3. Nov 6, 2026
    Start date Nov 10, 2026→Nov 11, 2026
  4. Nov 5, 2026
    Start date Nov 9, 2026→Nov 10, 2026
  5. Nov 4, 2026
    Start date Nov 8, 2026→Nov 9, 2026
  6. Nov 3, 2026
    Start date Nov 5, 2026→Nov 8, 2026
  7. Nov 2, 2026
    Start date Nov 4, 2026→Nov 5, 2026
  8. Oct 30, 2026
    Start date Nov 3, 2026→Nov 4, 2026
  9. Oct 29, 2026
    Start date Nov 2, 2026→Nov 3, 2026
  10. Oct 28, 2026
    Start date Nov 1, 2026→Nov 2, 2026
  11. Oct 27, 2026
    Start date Oct 29, 2026→Nov 1, 2026
  12. Oct 26, 2026
    Start date Oct 28, 2026→Oct 29, 2026
  13. Oct 23, 2026
    Start date Oct 27, 2026→Oct 28, 2026
  14. Oct 22, 2026
    Start date Oct 26, 2026→Oct 27, 2026
  15. Oct 21, 2026
    Start date Oct 25, 2026→Oct 26, 2026
  16. Oct 20, 2026
    Start date Oct 22, 2026→Oct 25, 2026
  17. Oct 19, 2026
    Start date Oct 21, 2026→Oct 22, 2026
    + 1 other change: verification date
  18. Oct 16, 2026
    Start date Oct 20, 2026→Oct 21, 2026
  19. Oct 15, 2026
    Start date Oct 19, 2026→Oct 20, 2026
  20. Oct 14, 2026
    Start date Oct 18, 2026→Oct 19, 2026
  21. Oct 13, 2026
    Start date Oct 14, 2026→Oct 18, 2026
  22. Oct 9, 2026
    Start date Oct 13, 2026→Oct 14, 2026
  23. Oct 8, 2026
    Start date Oct 12, 2026→Oct 13, 2026
  24. Oct 7, 2026
    Start date Oct 11, 2026→Oct 12, 2026
  25. Oct 6, 2026
    Start date Oct 8, 2026→Oct 11, 2026
  26. Oct 5, 2026
    Start date Oct 7, 2026→Oct 8, 2026
  27. Oct 2, 2026
    Start date Oct 6, 2026→Oct 7, 2026
  28. Oct 1, 2026
    Start date Oct 5, 2026→Oct 6, 2026
  29. Sep 30, 2026
    Start date Oct 4, 2026→Oct 5, 2026
  30. Sep 29, 2026
    Start date Oct 1, 2026→Oct 4, 2026
  31. Sep 28, 2026
    Start date Sep 30, 2026→Oct 1, 2026
  32. Sep 25, 2026
    Start date Sep 29, 2026→Sep 30, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06120244
Responsible party
Sponsor
First posted
Nov 7, 2023
Start date
Nov 15, 2026 (estimated)
Primary completion
Oct 31, 2033 (estimated)
Completion
Oct 31, 2033 (estimated)
Last update
Nov 10, 2026

Study contacts

Emmie de Wit, Ph.D.
Contact
emmie.dewit@nih.gov
(406) 375-7490
Emmie de Wit, Ph.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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