Healthy volunteer COVID-19 vaccine safety immunological response intradermal Accelerate Regimen
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or females at least 18-60 years of age (inclusive) 2. Have not received any COVID-19 vaccine? 3. Can understand Thai language through speaking, reading and writing? 4. Able to communicate through electronic tools such as Google form or line? 5. Capable of attending all study visits according to the study schedule. 6. Capable of informed consent and provision of written informed consent before any study procedures.
Exclusion criteria
Exclusion criteria: 1. Have history of severe drug or vaccine allergy (anaphylaxis)? 2. Have detected COVID-19 infection? 3. Have history of COVID-19 high risk contact? 4. Have history of Chronic respiratory disease, CVD, CKD, CVS, obesity, cancer and DM? 5. Positive result(s) from either antigen test kit. 6. Have received blood transfusion, plasma, blood product, blood component, immunoglobilins, antiviral or antibodies within the last 90 days? 7. Have history of cigarettes smoking, alcohol drinking and history of drug abuse? 8. Being pregnant? 9. have unstable disease or could not control the sysptom? 10. Have history of immunodeficiency or been using immunosuppressant or steriod drugs? 11. Have any unusual symptoms or medical history that considered unable to participate in the study?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunological Response 2 wk and 12 wk after complete vaccination IgG level | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety 7 days after vaccination Adverse effects | — |
Countries
Thailand
Contacts
Faculty of Medicine Siriraj Hospital, Mahidol University