Healthy Volunteers
Conditions
Interventions
None listed
Sponsors
Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults who, at the time of study participation, have no history or comorbidity requiring ongoing medication or treatment, or who have a history of chronic disease but whose condition is stable and who have not required a 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 authorities. 3) Have given written consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Those deemed inappropriate for participation in the study by the investigator 2) Patients with a history of or coexisting with 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 its related diseases, vasculitis syndrome, inflammatory bowel disease, Guillain-Barre syndrome, neuromyelitis optica) Multiple sclerosis, neuromyelitis optica). 3) Patients with a history of COVID-19 4) Inability to communicate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the rate of positivity for SARS-CoV-2 IgG antibodies. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be SARS-CoV-2 IgG antibody titer, T-cell immune response, 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