The response after the first and second dose of the BNT162b2 Covid-19 vaccine: real-world evidence from Greece

Immunogenicity after the first and second dose of the BNT162b2 mRNA Covid-19 vaccine: real-world evidence from Greece

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN61884303

Enrollment

450

Registered

2021-02-10

Start date

2021-01-25

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BNT162b2 mRNA COVID-19 vaccine immunogenicity among healthcare workers Not Applicable

Interventions

Based on the national prioritization scheme, healthcare providers were the first population group to receive the BNT162b2 mRNA Covid-19 vaccine in Greece. The first cohort of healthcare workers vaccin

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Occurence of any other vaccination 4 weeks prior to enrollment 2. Pregnancy or breastfeeding 3. Participation in any other clinical trial

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. PCR-confirmed cases of SARS-CoV-2 infection anytime after the first dose measured using hospital records 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	—

Countries

Greece

Contacts

Public ContactGeorgios Papazisis

papazisg@auth.gr+30 2310999323

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026