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

NCT04756817 | Completed

• 1 other identifier: 2/27.1.2021
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Immunogenicity after the first dose of the BNT162b2 mRNA Covid-19 vaccine

  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 21 after the first dose

  21 days after the first dose

• Immunogenicity after the second dose of the BNT162b2 mRNA Covid-19 vaccine

  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 21 after the second dose

  21 days after the second dose

• Immunogenicity after the second dose of the BNT162b2 mRNA Covid-19

  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 3 months after the second dose

  3 months after the second dose

• Immunogenicity after the second dose of the BNT162b2 mRNA Covid-19

  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 6 months after the second dose

  6 months after the second dose

Secondary Outcomes (1)

• PCR-confirmed cases of SARS-CoV-2 infection anytime after the first dose.

  6 months after the second dose

Eligibility Criteria

• Age: 85 Years - 100 Years
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly aged 85 or older prioritised for vaccination based on the greek national vaccination plan

You may qualify if:

• Age of 85 or older
• Without previously known SARS-CoV-2 infection, or
• With previous PCR-confirmed SARS-CoV-2 infection one to 4.5 months prior to vaccination

You may not qualify if:

• Occurence of any other vaccination 4 weeks prior to enrollment
• Participation in any other clinical trial

Sponsors & Collaborators

• G.Gennimatas General Hospital: lead
• Aristotle University Of Thessaloniki: collaborator

Study Sites (1)

G. Gennimatas General Hospital

Thessaloniki, Thessaloniki, 54635, Greece

Location

Related Publications (1)

• Kontopoulou K, Nakas CT, Ainatzoglou A, Ifantidou A, Ntotsi P, Katsioulis C, Papazisis G. Immunogenicity of the BNT162b2 mRNA Covid-19 vaccine in elderly people over 85 years of age in Greece: the GREVAXIMO study. Aging Clin Exp Res. 2021 Dec;33(12):3385-3389. doi: 10.1007/s40520-021-01997-7. Epub 2021 Oct 11.

  PMID: 34633648 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples retained, with no potential for DNA extraction from any retained sample

Study Officials

• Georgios Papazisis, As.Professor

  School of Medicine,Aristotle University of Thessaloniki

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pharmacology

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 16, 2021
• Study Start: February 13, 2021
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD and any additional supporting information will become available starting 6 months after publication
• Access Criteria: Completely anonymised, de-identified (stripped of all "direct identifiers") numerical data in spreadsheets will be shared with researchers from the academia and relevant research institutions after the publication of corresponding results in peer reviewed academic journals, for purposes of independent statistical analysis and verification of results. Participants will provide consent for the use of anonymised data for research purposes.

Locations

GR (1)