MedTrace Logo

Immunogenicity of the BNT162b2 Covid-19 Vaccine in Elderly People Aged 85 and Older in Greece

NCT04756817 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 297

Last updated 2022-08-05

No results posted yet for this study

Summary

Real-world evidence confirming the effectiveness and safety of the new COVID-19 vaccines among the elderly is currently lacking. However, scarce (sparse) data derived from phase II/III trials attest to a weaker humoral immune response generated post-immunization among seniors, in contrast to younger adults. According to the national priority vaccination scheme the age group of 85 and older was the first to receive the BNT162b2 mRNA Covid-19 vaccine in Greece. The aim of the study is to enhance our insight into the humoral immunity and antibody generation elicited by the BNT162b2 mRNA Covid-19 vaccine among the elderly. The study population will include people aged 85 or older who are either uninfected or have a positive history of PCR-confirmed SARS-CoV-2 infection occurring one to 4.5 months prior to vaccination. Upon receipt of informed consent, a cohort of persons vaccinated in the two vaccination centers of the "G. Gennimatas" General Hospital of Thessaloniki will be followed over a period of six months post-injection of the second dose. To monitor the immunogenicity of the BNT162b2 mRNA Covid-19 vaccine, the SARS-CoV-2 IgG II Quant assay will be applied to conduct both 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 21 after the first dose, day 21 after the second dose and within 3 and 6 months after the second dose.

Conditions

  • Immunogenicity, Vaccine

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    collaborator OTHER

  • G.Gennimatas General Hospital

    lead OTHER

Principal Investigators

  • Georgios Papazisis, As.Professor · School of Medicine,Aristotle University of Thessaloniki

Eligibility

Min Age
85 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-13
Primary Completion
2021-08-30
Completion
2021-09-30

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04756817 on ClinicalTrials.gov