Safety, tolerability, and antibody response after intradermal vaccination of COVID-19 vaccine; PFE-BNT in adults who have completed two-doses of Verocell (inactivated vaccine)
Phase 4
Completed
- Conditions
- ocal reactions and systemic reactions after ID injection of PFE-BNT , antibody response after ID injection of PFE-BNTimmunogenicityside effects
- Registration Number
- TCTR20211023002
- Lead Sponsor
- ampang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
participants were adults aged more than 18 years who completed 2 doses of a three-week schedule of Verocell, and have not had SARS-CoV-2 infection.
Exclusion Criteria
Participants were excluded from the study if they: had history of severe adverse or allergic reactions to previous vaccinations, were pregnancy or planned pregnancy within 4 weeks after vaccination, used of systemic or topical corticosteroids, had bleeding diathesis , received other Covid-19 vaccine, and had SARS-CoV-2 infection before collecting post ID injection blood sample.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability immediate, 30 minutes, day 1, day 7, and day 30 Direct observe , Vaccine side effect report form
- Secondary Outcome Measures
Name Time Method Antibody response Before receiving ID injection, at day 30 after ID injection immunoglobulin class G (IgG) antibodies to the receptor binding domain (RBD) of the S1 subunit of the spike protein of SARS-CoV-2.