Clinical study to establish a method for measuring Anti-SARS-CoV-2 spike-specific antibody titers used for evaluation of COVID-19 nasal vaccine - Clinical study to establish a method for measuring Anti-SARS-CoV-2 spike-specific antibody titers

Chiba University Hospital Department of Human Mucosal Vaccinology0 sites45 target enrollmentJuly 23, 2022

ConditionsCoronavirus disease (COVID-19)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronavirus disease (COVID-19)
Sponsor: Chiba University Hospital Department of Human Mucosal Vaccinology
Enrollment: 45
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 23, 2022

End Date

March 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Chiba University Hospital Department of Human Mucosal Vaccinology

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•\[Cohort A: Those who are expected to exert mucosal immunity and meet the following conditions (1\) and (2\)] (1\) Has a history of SARS\-CoV\-2 positive judgment (2\) COVID\-19 mRNA vaccine has been inoculated after SARS\-CoV\-2 infection, and it is within 90 days of vaccination at the time of consent acquisition. \[Cohort B: Those who are expected not to exert mucosal immunity and meet the following conditions (1\) and (2\)] (1\) No history of SARS\-CoV\-2 infection (including suspected infection) (2\) No history of COVID\-19 vaccination, or more than 180 days have passed since COVID\-19 vaccination at the time of consent acquisition. \[Common to Cohort A, B] Those who have received sufficient explanation in participating in this research, and who have obtained the voluntary written consent of the research subject after sufficient understanding. \[Standards common to cohorts A and B] 1\) Those who have not passed 14 days since the onset of SARS\-CoV\-2 2\) Those who have an otolaryngology disease (however, pollinosis in the non\-scattering period is not excluded) and are judged to be ineligible by the principal investigator or the research coordinator. 3\) Those who have periodontal disease and are judged to be ineligible by the principal investigator or the research coordinator. 4\) Pregnant women 5\) Others who are judged to be ineligible by the principal investigator or the research coordinator It was \[Criteria for Cohort A only] 6\) Those who are receiving steroids (excluding external preparations) or immunosuppressants 7\) Persons suffering from diseases associated with immunosuppression such as acquired immunodeficiency syndrome