HealthyNCT06120244
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
An observational study of Healthy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 31 Oct 2033
- Phase
- Observational
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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 informed consent.
- Willing to allow biological samples and data to be stored for future research.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rocky Mountain Laboratories
Hamilton, Montana, 59840
Emmie de Wit, Ph.D., 406-375-7490, emmie.dewit@nih.gov
About this study
Official title: Establishment of a Biobank of Nasal Epithelium Samples From Healthy Volunteers
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.
Read more
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.
- Conditions
- Healthy
- Keywords
- Nasal Epithelium
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 |
|---|---|---|
| Healthy Volunteers | Healthy volunteers aged 18 years and older |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start28 Oct 2026 (estimated)
- Primary completion31 Oct 2033 (estimated)
- Study completion31 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Emmie de Wit, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120244
- Sponsor's protocol ID
- 10001862
- Other IDs
- 001862-I
- Status last verified
- 15 Oct 2026
- First submitted
- 4 Nov 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD underlying published data will be shared upon request after appropriate collaboration agreements are in place.
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 35164569Stokes 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