Healthy volunteers
Conditions
Interventions
None listed
Sponsors
Kobe City Medical Center General Hospital, Department of Hematology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults who do not have any history or comorbidity requiring continuous medication or treatment at the time of study entry, or who have a history of chronic disease but whose condition is stable and who have not required any change in treatment or hospitalization within the past 6 weeks. 2) Willing to receive the SARS-CoV-2 vaccination initiated by the Japanese government or local government. 3) Those who have given written consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Those that the principal investigator or sub-investigator deems inappropriate for participation in the study 2) Patients with a history or coexistence of immunosuppressive medication, autoimmune diseases (systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis/polymyositis, mixed connective tissue disease, systemic scleroderma, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, spondyloarthritis and related diseases, vasculitis syndrome, inflammatory bowel disease, Guillain-Barre syndrome, multiple sclerosis, neuromyelitis optica) Multiple sclerosis, neuromyelitis optica). 3) Patients with a history of COVID-19 4) Patients who are unable to communicate with others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the rate of positivity of the SARS-CoV-2 IgG antibody. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include SARS-CoV-2 IgG antibody titer, peripheral blood lymphocyte fraction, IgG, IgA, IgM, and presence and content of post-vaccination adverse reactions. | — |
Countries
Japan
Contacts
Public ContactMasashi Nishikubo
Kobe City Medical Center General Hospital Department of Hematology
Outcome results
None listed