Coronavirus disease (COVID-19)
Conditions
Interventions
Prescribe two hospital visits, and collect blood, upper respiratory tract specimens, and saliva for each visit.
Sponsors
Chiba University Hospital Department of Human Mucosal Vaccinology
NATIONAL INSTITUTE OF INFECTIOUS DISEASE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Z-Score(Numerical value representing the accuracy of the assay system calculated from data variability and signal intensity) | — |
Secondary
| Measure | Time frame |
|---|---|
| S/B (Numerical value representing the accuracy of the assay system calculated as ratio of signal value to background value) | — |
Countries
Japan
Contacts
Public ContactMorio Nagira
Chiba University Hospital Department of Human Mucosal Vaccinology
Outcome results
None listed