The response after the first and second dose of the BNT162b2 Covid-19 vaccine: real-world evidence from Greece
Phase 4
Completed
- Conditions
- BNT162b2 mRNA COVID-19 vaccine immunogenicity among healthcare workersNot Applicable
- Registration Number
- ISRCTN61884303
- Lead Sponsor
- Georgios Gennimatas General Hospital
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34397348/ (added 06/03/2024) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35746484/ (added 06/03/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 425
Inclusion Criteria
1. Age of 18 - 69 years
2. Without previously known SARS-CoV-2 infection, or
3. With previous PCR-confirmed SARS-CoV-2 infection one to 4.5 months prior to vaccination
Exclusion Criteria
1. Occurence of any other vaccination 4 weeks prior to enrollment
2. Pregnancy or breastfeeding
3. Participation in any other clinical trial
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity of the BNT162b2 mRNA Covid-19 vaccine measured using the SARS-CoV-2 IgG II Quant assay to conduct a qualitative and quantitative determination of IgGs against the receptor-binding domain (RBD) of the S1 subunit of the SARS-CoV-2 spike protein on day 14 after the first dose, day 14 after the second dose and within 3, 6, 9 and 12 months after the second dose.
- Secondary Outcome Measures
Name Time Method 1. PCR-confirmed cases of SARS-CoV-2 infection anytime after the first dose measured using hospital records<br>2. Reactogenicity monitored through adverse drug reaction reporting forms completed on day 14 after the first dose, day 14 after the second dose and within 3, 6, 9 and 12 months after the second dose