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Intradermal second booster COVID-19 vaccinatio

Phase 4
Completed
Conditions
The second booster intradermal mRNA-based vaccine following the 2-dose primary series of ChAdOx1 (AstraZeneca) can provide a sufficient level of immunity against SAR-CoV-2.
booster vaccine, SAR-CoV2, older adult, intradermal vaccination, elderly, Thailand
Registration Number
TCTR20230411008
Lead Sponsor
Faculty of Medicine Siriraj hospital, Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
107
Inclusion Criteria

1. Aged 65 years old or more. 2. Having a 2-dose primary series of ChAdOx1 (AstraZeneca) vaccine for 12-24 weeks followed by a booster mRNA-based vaccine. 3. Stable and well-controlled chronic diseases. 4. Ability to understand and communicate in Thai language. 5. Ability to attend the appointment. 6.Ability to give informed consent

Exclusion Criteria

1. Having a history of anaphylaxis to drug or other vaccines. 2. Having a previous history of Covid-19 infection or high-risk of Covid-19 infection. 3. Having any type of vaccination 2 week before the
recruitment. 4. Having any type of immunodeficiency. 5. Taking any type of immunosuppressive agent or cytotoxic drug. 6. Acute illness or acute inflammation. 7. Having blood transfusion or other blood products, immunoglobulin, antiviral agent, or antibody within previous 90 days. 8. Having any skin disease not suitable for intradermal injection.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Immunological response 2-4 weeks after vaccination SARSCov-2 IgG by Chemiluminescent microparticle immunoassay (CMIA),Neutralizing antibody assay 2-4 weeks after vaccination percent foci reduction, inhibitory concentration at 50%
Secondary Outcome Measures
NameTimeMethod
vaccine adverse event 7 days after vaccination number of adverse event
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