Establishing biomarkers for safety assessment through measurement and observational studies of cellular components in nasal mucosa

Measurement and observational study of cellular components in nasal lavage fluid to investigate the potential of nasal mucosa as a biomarker for evaluating the efficacy and safety of mucosal vaccines - Biomarkers for the evaluation of efficacy and safety of mucosal vaccines

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056305

Enrollment

150

Registered

2024-12-02

Start date

2024-12-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Prescribe one hospital visit, and collect blood, upper respiratory tract specimens

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have been fully informed about their participation in the study, and who have given their free and voluntary written consent based on a full understanding of the study.

Exclusion criteria

Exclusion criteria: Persons who fall into one of the following categories 1) who have used antibiotics within the past 10 weeks 2) Who have used proton pump inhibitors (drugs for treating hyperacidity or gastric ulcers) within the past 10 weeks 3) Pregnant women 4) Any other person deemed ineligible by the principal investigator or research assistant.

Design outcomes

Primary

Measure	Time frame
Correlation coefficient (Numerical value representing the correlation between parameters related to vaccination and biomarkers included in nasal mucosa)	—

Secondary

Measure	Time frame
S/B (Numerical value representing the accuracy of the assay system calculated as ratio of signal value to a background value, characterize nasal fluid)	—

Countries

Japan

Contacts

Public ContactYuko Yamamoto

Chiba University Synergy institute for Futuristic Mucosal Vaccine Research and Development

wkyoten-suprtura02@chiba-u.jp043-226-2119

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026