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A Pilot Study: Safety and Immunological Response following Intradermal COVID-19 vaccinatio

Phase 1
Conditions
healthy volunteer
Safety and Immunological Response
Intradermal
COVID-19 vaccination
Registration Number
TCTR20210903006
Lead Sponsor
Faculty of Medicine Siriraj Hospital, Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
80
Inclusion Criteria

1. Males or females at least 18-60 years of age, 2. Have not received any COVID-19 vaccine?, 3. Can understand Thai language through speaking, 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

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. Positive result (s) from either antigen test kit, 5. Have history of Chronic respiratory disease, CVD, CKD, CVS, obesity, cancer and DM?, 6. Have received blood transfusion, plasma, blood product, blood component, immunoglobulins, 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 symptom?, 10. Have history of immunodeficiency or been using immunosuppressant or steroid drugs?, 11. Have any unusual symptoms or medical history that considered unable to participate in the study?

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Immunogenicity response at 2 weeks and 12 weeks after second dose IgG level
Secondary Outcome Measures
NameTimeMethod
Safety at 7 days after vaccination Adverse event
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