Not applicable-Healthy adults
Conditions
Interventions
0.3mL of COMIRNATY is injected once into the deltoid muscle of the upper arm of the Subject
Sponsors
Furuie Hidetoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects of this study are those who meet all of the following: 1. Subjects aged 18 years or older and younger than 65 years at the time of informed consent (both males and females) 2. Subjects who have received information on study objectives and methods and who have provided informed consent by documentation 3. Subjects who can cooperate with the designated vaccination, blood sampling, and hospital visits during time period of this study 4. In Visit 1, a subject whose HLA genotype falls under any of the following: A*24:02, A*02:01, A*02:06, A*26:01, A*02:07 Those who do not meet the criteria are also eligible for vaccination, but not for Visit 2 testing. 5. Subjects who have been receiving SARS-CoV-2 vaccination for at least 6 months since the time of informed consent
Exclusion criteria
Exclusion criteria: Those who meet any of the following criteria will be excluded: 1. Subjects with a history of severe allergic reactions to SARS-CoV-2 vaccination or any of its components. 2. Women who are pregnant or breastfeeding 3. Immunosuppressed or on immunosuppressive treatment (e.g., long-term steroid use, anticancer drugs, immunosuppressants, etc.) 4. Subjects with bleeding tendency or extreme anemia considered to be difficult to collect blood samples 5. Subjects with serious underlying diseases, such as heart disease, kidney disease, liver disease, or malignancy 6. Infectious disease test positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen antibody, or syphilitic serological response 7. Subjects weighing less than 50 kg prior to collection of blood samples for study in Visit2 8. Subjects who have received investigational products or other invasive procedures (e.g., blood collection exceeding the total 200 mL) in another clinical study or clinical trials within 90 days prior to Visit 1 of this study, or who are scheduled to participate in other clinical studies or clinical trials etc. (excluding observational studies without blood collection, etc.) during the course of this study. 9. Subjects who are judged as inappropriate for other reason by the principal investigator or subinvestigator (investigator, etc.) Intervention: 0.3mL of COMIRNATY is injected once into the deltoid muscle of the upper arm of the Subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| none | — |
Contacts
Public ContactHidetoshi Furuie
Medical Corporation Heishinkai OPHAC Hospital
Outcome results
None listed