Immunogenicity, VaccineGREVAXIMONCT04756817
Immunogenicity of the BNT162b2 Covid-19 Vaccine in Elderly People Aged 85 and Older in Greece
An observational study of Immunogenicity, Vaccine, run by G.Gennimatas General Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 85 to 100 years
- Conditions the study is for
- Immunogenicity, Vaccine
- How many people
- 297 participants
- Where
- 1 siteGreece
- Study dates
- 13 Feb 2021to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 85 to 100 years
- All sexes
- Older adult
Study population: Elderly aged 85 or older prioritised for vaccination based on the greek national vaccination plan
Who may be able to join
- 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
Who cannot join
- Occurence of any other vaccination 4 weeks prior to enrollment
- Participation in any other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity of the BNT162b2 mRNA Covid-19 Vaccine in Elderly People Over 85 Years of Age: Real World Data From Greece
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.
Read the detailed description
Real world data regarding the effectiveness and safety of the new COVID-19 vaccines in older people are currently lacking. The sparse data from Phase II/II trials suggest a reduction in antibody responses in older people compared to younger participants. The over-85 age group was the first group to receive the BNT162b2 mRNA Covid-19 vaccine in Greece according to the national priority vaccination scheme. The aim of the study is to enhance insight into the immunity and antibody generation elicited by the BNT162b2 mRNA Covid-19 vaccine among elderly people over age 85. The study population will include both uninfected vaccinated persons and persons with PCR-confirmed previous SARS-CoV-2 infection occurring one to 4.5 months prior to vaccination. After informed consent a cohort of persons vaccinated in the two vaccination centers of the "G. Gennimatas" General Hospital of Thessaloniki will be followed for six months post-second dose injection. The immunogenicity of the vaccine will be 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, day 21 after the second dose and within 3 and 6 months after the second dose.
Having set the positivity threshold of the immunoassay (50 AU/ml) as a cut-off point, participants will be classified both by history of infection with SARS-CoV-2 and by SARSCoV-2 IgG II Quant assay outcomes. Subsequently, the IgG geometric mean concentration (GMC) and its 95% Confidence Interval will be calculated, based on the recorded antibody concentration values. Regarding the reactogenicity of the vaccine, on the day of blood collection the participants will be asked to report their experienced side effects. Of note, participants are asked to officially report all unsolicited adverse drug reactions (ADRs) to the National Medicines Organization via the Yellow Card scheme. The study protocol has been endorsed and ethical approval was obtained by the ethics committee of the scientific council of the "G. Gennimatas" General Hospital (protocol number:2/12.02.2021).
Regarding the reactogenicity of the vaccine, on the day of blood collection the participants will be asked to report their experienced side effects. Of note, participants are asked to officially report all unsolicited adverse drug reactions (ADRs) to the National Medicines Organization via the Yellow Card scheme.
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:2/12.02.2021).
- Conditions
- Immunogenicity, Vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after the second dose
Secondary outcomes (1)
PCR-confirmed cases of SARS-CoV-2 infection anytime after the first dose.
PCR-confirmed cases of SARS-CoV-2 infection anytime after the first dose measured using hospital records
Measured: 6 months after the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start13 Feb 2021
- Primary completion30 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immunogenicity, VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- G.Gennimatas General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Responsible party
- Principal investigator, Georgios Papazisis, Aristotle University Of Thessaloniki
- Investigators
- Georgios Papazisis, As.Professor, Study chair, School of Medicine,Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756817
- Sponsor's protocol ID
- 2/27.1.2021
- Acronym
- GREVAXIMO
- Status last verified
- Aug 2022
- First submitted
- 14 Feb 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study will be available from the corresponding author on reasonable request.
Publications
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.
PubMed 34633648
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of the BNT162b2 mRNA Covid-19 Vaccine in Elderly People Over 85 Years of Age: Real World Data From Greece
- ClinicalTrials.gov ID
- NCT04756817
- Acronym / sponsor ID
- GREVAXIMO / 2/27.1.2021
- Conditions
- Immunogenicity, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- G.Gennimatas General HospitalUniversity, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Study start
- 13 Feb 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Real world data regarding the effectiveness and safety of the new COVID-19 vaccines in older people are currently lacking. The sparse data from Phase II/II trials suggest a reduction in antibody responses in older people compared to younger participants. The over-85 age group was the first group to receive the BNT162b2 mRNA Covid-19 vaccine in Greece according to the national priority vaccination scheme. The aim of the study is to enhance insight into the immunity and antibody generation elicited by the BNT162b2 mRNA Covid-19 vaccine among elderly people over age 85. The study population will include both uninfected vaccinated persons and persons with PCR-confirmed previous SARS-CoV-2 infection occurring one to 4.5 months prior to vaccination. After informed consent a cohort of persons vaccinated in the two vaccination centers of the "G. Gennimatas" General Hospital of Thessaloniki will be followed for six months post-second dose injection. The immunogenicity of the vaccine will be 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, day 21 after the second dose and within 3 and 6 months after the second dose.
Having set the positivity threshold of the immunoassay (50 AU/ml) as a cut-off point, participants will be classified both by history of infection with SARS-CoV-2 and by SARSCoV-2 IgG II Quant assay outcomes. Subsequently, the IgG geometric mean concentration (GMC) and its 95% Confidence Interval will be calculated, based on the recorded antibody concentration values. Regarding the reactogenicity of the vaccine, on the day of blood collection the participants will be asked to report their experienced side effects. Of note, participants are asked to officially report all unsolicited adverse drug reactions (ADRs) to the National Medicines Organization via the Yellow Card scheme. The study protocol has been endorsed and ethical approval was obtained by the ethics committee of the scientific council of the "G. Gennimatas" General Hospital (protocol number:2/12.02.2021).
Regarding the reactogenicity of the vaccine, on the day of blood collection the participants will be asked to report their experienced side effects. Of note, participants are asked to officially report all unsolicited adverse drug reactions (ADRs) to the National Medicines Organization via the Yellow Card scheme.
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:2/12.02.2021).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 85 to 100 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly aged 85 or older prioritised for vaccination based on the greek national vaccination plan
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Occurence of any other vaccination 4 weeks prior to enrollment
- Participation in any other clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunogenicity after the first dose of the BNT162b2 mRNA Covid-19 vaccine
Time frame: 21 days after the first dose
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
Immunogenicity after the second dose of the BNT162b2 mRNA Covid-19 vaccine
Time frame: 21 days after the second dose
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
Immunogenicity after the second dose of the BNT162b2 mRNA Covid-19
Time frame: 3 months after the second dose
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
Immunogenicity after the second dose of the BNT162b2 mRNA Covid-19
Time frame: 6 months after the second dose
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
1 secondary outcome
PCR-confirmed cases of SARS-CoV-2 infection anytime after the first dose.
Time frame: 6 months after the second dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: PubMed 34633648Kontopoulou 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.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Papazisis, As.Professor study chair
School of Medicine,Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunogenicity, Vaccine, run by G.Gennimatas General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity after the first dose of the BNT162b2 mRNA Covid-19 vaccine (time frame: 21 days after the first dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.