Immunogenicity after the First Dose of the BNT162b2 mRNA COVID-19 Vaccine: Real-World Evidence from Greek Healthcare Workers

10 Pages Posted: 19 Feb 2021

See all articles by Konstantina Kontopoulou

Konstantina Kontopoulou

G. Gennimatas General Hospital

Alexandra Ainatzoglou

Aristotle University of Thessaloniki - Department of Clinical Pharmacology

Athina Ifantidou

G. Gennimatas General Hospital

Christos Nakas

University of Bern - University Institute of Clinical Chemistry; University of Thessaly

Georgia Goudi

G. Gennimatas General Hospital

Eleni Antoniadou

G. Gennimatas General Hospital

Vasilios Adamopoulos

G. Gennimatas General Hospital

Nikitas Papadopoulos

G. Gennimatas General Hospital

Georgios Papazisis

Aristotle University of Thessaloniki - Department of Clinical Pharmacology; Clinical Trials Unit, Special Unit for Biomedical Research and Education, School of Medicine, Aristotle University

Date Written: February 3, 2021

Abstract

Background: The BNT162b2 mRNA Covid-19 vaccine that was recently launched exhibited high levels of efficacy and safety in a phase III RCT, along with robust immunogenicity in phase II trials. However, the release of phase IV studies verifying these preliminary findings by means of real-life evidence is essential.

Methods: We measured titers of neutralizing IgGs against the receptor-binding domain (RBD) of the S1 subunit of the spike protein of SARS-CoV-2 14 days post-immunization of 425 healthcare providers utilizing the SARS-CoV-2 IgG II Quant assay and estimated the geometric mean concentration (GMC) of SARS-CoV-2-specific IgGs both in the previously-infected group and among the uninfected. The trial is registered on the International Standard Randomized Controlled Trial Number registry (study ID: ISRCTN61884303).

Results: 392 of study participants 92.24% (95% CI:89.27, 94.43) had a positive SARS-CoV-2 IgG II Quant assay, while 33 subjects had an IgG concentration lower than 50 AU/ml (GMC 24.80303 AU/ml; 95% CI:19.190, 30.41612). All 63 previously-infected convalescent participants had very high SARS-CoV-2-specific antibody titers with a GMC of 19993,61AU/ml. Regarding age, antibody titers did not significantly differ in the range of 20-50 years, being however significantly lower in the 50-60 age group and dropping even further in subjects over the age of 60. Adverse reactions were overall mild, including pain at the site of the injection, fatigue, myalgias, headache and chills. No serious adverse events were reported in this study.

Conclusion: To our knowledge, this is the first phase IV study in Greece presenting real-world evidence on the immunogenicity of the first dose of the BNT162b2 mRNA Covid-19 vaccine in a sample of 425 healthcare providers.

Note: Trial Registration: The trial is registered on the International Standard Randomized Controlled Trial Number registry (study ID: ISRCTN61884303).

Funding: None.

Declaration of Interests: None to declare.

Ethics Approval Statement: The study protocol was approved and ethical approval was obtained by the ethics committee of the scientific council of the G. Gennimatas General Hospital (protocol number:1/13.1.2021).

Keywords: vaccine, BNT162b2, SARS-CoV-2, immunogenicity, healthcare workers, Greece, reactogenicity

Suggested Citation

Kontopoulou, Konstantina and Ainatzoglou, Alexandra and Ifantidou, Athina and Nakas, Christos and Goudi, Georgia and Antoniadou, Eleni and Adamopoulos, Vasilios and Papadopoulos, Nikitas and Papazisis, Georgios, Immunogenicity after the First Dose of the BNT162b2 mRNA COVID-19 Vaccine: Real-World Evidence from Greek Healthcare Workers (February 3, 2021). Available at SSRN: https://ssrn.com/abstract=3786138 or http://dx.doi.org/10.2139/ssrn.3786138

Konstantina Kontopoulou

G. Gennimatas General Hospital ( email )

Eth. Aminis 41
Thessaloniki, 54635
Greece

Alexandra Ainatzoglou

Aristotle University of Thessaloniki - Department of Clinical Pharmacology ( email )

Greece

Athina Ifantidou

G. Gennimatas General Hospital

Eth. Aminis 41
Thessaloniki, 54635
Greece

Christos Nakas

University of Bern - University Institute of Clinical Chemistry ( email )

Bern
Switzerland

University of Thessaly ( email )

Gaiopolis Campus
Larissa, 41110
Greece

Georgia Goudi

G. Gennimatas General Hospital

Eth. Aminis 41
Thessaloniki, 54635
Greece

Eleni Antoniadou

G. Gennimatas General Hospital ( email )

Eth. Aminis 41
Thessaloniki, 54635
Greece

Vasilios Adamopoulos

G. Gennimatas General Hospital

Eth. Aminis 41
Thessaloniki, 54635
Greece

Nikitas Papadopoulos

G. Gennimatas General Hospital

Eth. Aminis 41
Thessaloniki, 54635
Greece

Georgios Papazisis (Contact Author)

Aristotle University of Thessaloniki - Department of Clinical Pharmacology ( email )

Greece

Clinical Trials Unit, Special Unit for Biomedical Research and Education, School of Medicine, Aristotle University

University Campus
S. Kyriakidi 1
Thessaloniki, Thessaloniki
Greece

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