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Safety and Immunological Response following Intradermal COVID-19 vaccination in The Booster (3rd dose)

Phase 1
Conditions
healthy volunteerImmunization
COVID-19 Vaccine
Intradermal
Booster
3rd dose
Registration Number
TCTR20211102006
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
105
Inclusion Criteria

1.Males or females at least 18 years of age (inclusive), 2. Have completed primary series of COVID-19 vaccines (2 doses of Sinovac, AstraZeneca, or mRNA) between 6-10 weeks?, 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

1. Have history of severe drug or vaccine allergy (anaphylaxis)?, 2. Have ever been detected COVID-19 infection?, 3.Have any history of contacting COVID-19 patient (high risk contact)?, 4. Positive result of antigen test kit?, 5. Have received blood transfusion, plasma, blood product, blood component, immunoglobulins, antiviral or antibodies within the last 90 days?, 6.Have history of cigarettes smoking, alcohol drinking and history of drug abuse? , 7. Being pregnant?, 8. Have unstable disease or could not control the symptom?, 9. Have history of immunodeficiency or been using immunosuppressant or steroid drugs?, 10. 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
Immune response 2 wk after vaccination IgG level
Secondary Outcome Measures
NameTimeMethod
umber of adverse event 7 days after vaccination Patient reported outcome using a questionnaire
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