Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers

NCT06120244 | Recruiting

• 2 other identifiers: 10001862001862-I
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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....

Conditions

Healthy

Keywords

Nasal Epithelium

Outcome Measures

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.

  10 years

Study Arms (1)

Healthy Volunteers

Healthy volunteers aged 18 years and older

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Rocky Mountain Laboratories

Hamilton, Montana, 59840, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 35164569 BACKGROUND

• 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.

  PMID: 25058379 BACKGROUND

Study Officials

• Emmie de Wit, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmie de Wit, Ph.D.

CONTACT

(406) 375-7490; emmie.dewit@nih.gov

Study Design

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

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): October 31, 2033
• Study Completion (Estimated): October 31, 2033
• Last Updated: July 10, 2025

Record last verified: 2025-07-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)