Intradermal booster COVID-19 vaccinatio

Phase 4

Recruiting

• Conditions: 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, third dose, SAR-CoV2, older adult

• Registration Number: TCTR20220112002
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-12
• Study Completion: 2022-06-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Aged 65 years old or more. 2. Having a 2-dose primary series of ChAdOx1 (AstraZeneca) vaccine for 12-24 weeks. 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. No acute illness or acute inflammation. 7. Having blood transfusion or other blood products, immunoglobulin, antiviral agent, or antibody within previous 90 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vaccine adverse event 7 days number of adverse event

Secondary Outcome Measures

Name	Time	Method
SARSCov-2 IgG 1 day AU/ml,T cell response 1 day T cell Elispot,Neutralizing antibody assay, Focus reduction neutralization test 1 day percent foci reduction, inhibitory concentration at 50%