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Assessing Immune Response of Different COVID-19 Vaccines in Older Adults (EU-COVAT-1)

Primary Purpose

Vaccination Reaction, COVID-19, Vaccination; Infection

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Comirnaty(BTN162b2)
Spikevax (mRNA-1273)
Sponsored by
Oliver Cornely, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaccination Reaction focused on measuring SARS-CoV-2, COVID-19, Vaccination, Immunisation, Comirnaty, Spikevax, Booster, Elderly

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is ≥75 years old).
  • Prior to study entry the subject was vaccinated with one of the following vaccination regimens (1st + 2nd + 3rd dose):

BNT162b2 + BNT162b2 + BNT162b2

BNT162b2 + BNT162b2 + mRNA-1273

mRNA-1273 + mRNA-1273 + mRNA-1273

mRNA-1273 + mRNA-1273 + BNT162b2

ChAdOx-1-S + ChAdOx-1-S + BNT162b2

ChAdOx-1-S + ChAdOx-1-S + mRNA-1273

The last dose of the above listed vaccinations must have been administered at least 1 month prior to study entry. Vaccination status should be documented in the source data and will be captured in the eCRF.

- Written informed consent from subject has been obtained.

Exclusion Criteria:

  • Prior to study entry the subject got vaccinated with a regimen not included in the list given above.
  • Last anti-SARS-CoV-2 vaccine dose administered less than one month prior to study entry.
  • Vaccination against a disease other than COVID-19 within 2 weeks prior to study entry. Only exception: Influenza vaccination which is allowed at any time.
  • Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator.
  • Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to >10 mg/day prednisolone.
  • Subject simultaneously participates in another clinical trials or has participated in the past 30 days.
  • Subjects unable to report solicited adverse events.
  • Subject with any contraindications to the vaccines in the trial. A list of contraindications as listed in the Summary of medicinal Product Characteristics (SmPC, the Fachinformation in Germany), if appropriate.

Sites / Locations

  • University Hospital Cologne
  • University Hospital Frankfurt
  • Hannover Medical School Hospital
  • Cork University Hospital
  • Royal College of Surgeons in Ireland
  • St. Vincent's University Hospital
  • Mater Misericordiae University Hospital
  • St. James's Hospital
  • Inlita JSC
  • Vilnius University Hospital Santaros Klinikos
  • Helse Bergen HF, Haukeland University Hospital
  • Hospital Universitari Germans Trias i Pujol
  • Bellvitge University Hospital
  • Reina Sofia University Hospital
  • La Paz University Hospital
  • Biodonostia Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Comirnaty-Comirnaty-Comirnaty

Spikevax-Spikevax-Spikevax

Vaxzevria-Vaxzevria-Spikevax

Vaxzevria-Vaxzevria-Comirnaty

Spikevax-Spikevax-Comirnaty

Comirnaty-Comirnaty-Spikevax

Arm Description

Participants are already fully vaccinated with 3x Comirnaty (BNT162b2) when entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.

Participants are already fully vaccinated with 3x Spikevax (mRNA-1273) when entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.

Participants are already fully vaccinated with 2x Vaxzevria (ChAdOx-1-S) and 1x Spikevax (mRNA-1273) when entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.

Participants are already fully vaccinated with 2x Vaxzevria (ChAdOx-1-S) and 1x Comirnaty (BNT162b2) when entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.

Participants are already fully vaccinated with 2x Spikevax (mRNA-1273) and 1x Comirnaty (BNT162b2) when entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.

Participants are already fully vaccinated with 2x Comirnaty (BNT162b2) and 1x Spikevax (mRNA-1273) entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.

Outcomes

Primary Outcome Measures

Antibody titre increase 14 days after 4th vaccination dose.
Rate of 2-fold antibody titre increase 14 days after 4th vaccination dose measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus.

Secondary Outcome Measures

Antibody titre level against wild-type SARS-CoV-2 after a 4th vaccination dose
Antibody titre level at 12 months after a 4th vaccination dose measured by a quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA assay).
Neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose.
Neutralizing antibody titre (Virus Neutralisation Assay) against wild-type 14 days after a 4th vaccination dose, to be determined in a subgroup only.
Neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose.
Neutralizing antibody titre (Virus Neutralisation Assay) against variants of Concern (VOC) 14 days after a 4th vaccination dose, to be determined in a subgroup only.
Neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose.
Neutralizing atibody titre (Virus Neutralisation Assay) against wild-type SARS-CoV-2 at 12 months after a 4th vaccination dose, to be determined in a subgroup only.
Neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose.
Neutralizing atibody titre (Virus Neutralisation Assay) against variants of concern at 12 months after a 4th vaccination dose, to be determined in a subgroup only.

Full Information

First Posted
November 11, 2021
Last Updated
January 16, 2023
Sponsor
Oliver Cornely, MD
Collaborators
European Commission, VACCELERATE
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1. Study Identification

Unique Protocol Identification Number
NCT05160766
Brief Title
Assessing Immune Response of Different COVID-19 Vaccines in Older Adults
Acronym
EU-COVAT-1
Official Title
A Multinational, Phase 2, Randomised, Adaptive Protocol to Evaluate Immunogenicity and Reactogenicity of Different COVID-19 Vaccines Administration in Older Adults (≥75) Already Vaccinated Against SARS-COV-2 (EU-COVAT-1_AGED)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Oliver Cornely, MD
Collaborators
European Commission, VACCELERATE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. Part B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV- 2 wild-type and variants in the elderly, a usually neglected population. Additional vaccines and extended follow-up visits can be added through amendments of this sub-protocol. As stated in the EU-COVAT master protocol, this trial, i.e., the EU-COVAT-1_AGED study, implements a specific safety monitoring strategy (see below). Cohorts and arms can be withdrawn or added as deemed necessary according to the criteria specified in this protocol
Detailed Description
PLEASE NOTE: This protocol refers to Part B of the clinical trial in which new accruals are randomized to a 4th vaccination (second booster) with either BNT162b2 or mRNA-1273. Part A of the present trial in which individuals received a 3rd vaccination (first booster) is closed to further recruitment as of January 13, 2022. With the massive roll-out of booster campaigns throughout Europe, Part A was abandoned because of a poor recruitment rate. Individuals in Part A are followed-up as specified in protocol version V04_0 and analyzed descriptively, the statistical analysis plan will be adapted accordingly. Randomisation in Part B Subjects who - prior to study entry - got a primary vaccination series and 3rd vaccination dose of either BNT162b2 & BNT162b2 & BNT162b2 or BNT162b2 & BNT162b2 & mRNA-1273 or mRNA-1273 & mRNA-1273 & mRNA-1273 or mRNA-1273 & mRNA-1273 & BNT162b2 or ChAdOx-1-S & ChAdOx-1-S & BNT162b2 or ChAdOx-1-S & ChAdOx-1-S & mRNA-1273 will receive a 4th vaccination dose with an allocation ratio of 1:1 to either BNT162b2 or mRNA-1273. Accordingly, there are 6 cohorts/arms (equalling 12 intervention arms). All individuals who were randomized to BNT162b2 represent Group 1, all individuals who were randomized to mRNA-1273 represent Group 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination Reaction, COVID-19, Vaccination; Infection
Keywords
SARS-CoV-2, COVID-19, Vaccination, Immunisation, Comirnaty, Spikevax, Booster, Elderly

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a randomised controlled, adaptive, multicentre Phase II Part B protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. This trial foresees testing of different vaccines as a fourth vaccine dose ( second booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 and SARS-CoV-2 variants in the elderly.
Masking
None (Open Label)
Masking Description
No blinding is foreseen in this trial
Allocation
Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comirnaty-Comirnaty-Comirnaty
Arm Type
Active Comparator
Arm Description
Participants are already fully vaccinated with 3x Comirnaty (BNT162b2) when entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.
Arm Title
Spikevax-Spikevax-Spikevax
Arm Type
Active Comparator
Arm Description
Participants are already fully vaccinated with 3x Spikevax (mRNA-1273) when entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.
Arm Title
Vaxzevria-Vaxzevria-Spikevax
Arm Type
Active Comparator
Arm Description
Participants are already fully vaccinated with 2x Vaxzevria (ChAdOx-1-S) and 1x Spikevax (mRNA-1273) when entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.
Arm Title
Vaxzevria-Vaxzevria-Comirnaty
Arm Type
Active Comparator
Arm Description
Participants are already fully vaccinated with 2x Vaxzevria (ChAdOx-1-S) and 1x Comirnaty (BNT162b2) when entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.
Arm Title
Spikevax-Spikevax-Comirnaty
Arm Type
Active Comparator
Arm Description
Participants are already fully vaccinated with 2x Spikevax (mRNA-1273) and 1x Comirnaty (BNT162b2) when entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.
Arm Title
Comirnaty-Comirnaty-Spikevax
Arm Type
Active Comparator
Arm Description
Participants are already fully vaccinated with 2x Comirnaty (BNT162b2) and 1x Spikevax (mRNA-1273) entering the trial, only the 4th dose will be administered in the study. Treatment will be given as a single shot of either Comirnaty (BTN162b2) or Spikevax (mRNA-1273) using the approved dose and mode of administration of each vaccine included in this trial.
Intervention Type
Biological
Intervention Name(s)
Comirnaty(BTN162b2)
Other Intervention Name(s)
BioNTech/ Pfizer
Intervention Description
Single booster shot (4th dose) of already approved BioNTech/ Pfizer vaccine that protect against COVID-19 infection
Intervention Type
Biological
Intervention Name(s)
Spikevax (mRNA-1273)
Other Intervention Name(s)
Moderna
Intervention Description
Single booster shot (4th dose) of already approved Moderna vaccine that protect against COVID-19 infection
Primary Outcome Measure Information:
Title
Antibody titre increase 14 days after 4th vaccination dose.
Description
Rate of 2-fold antibody titre increase 14 days after 4th vaccination dose measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus.
Time Frame
14 days after 4th vaccination dose
Secondary Outcome Measure Information:
Title
Antibody titre level against wild-type SARS-CoV-2 after a 4th vaccination dose
Description
Antibody titre level at 12 months after a 4th vaccination dose measured by a quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA assay).
Time Frame
Up to 12 months after 4th vaccination dose
Title
Neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose.
Description
Neutralizing antibody titre (Virus Neutralisation Assay) against wild-type 14 days after a 4th vaccination dose, to be determined in a subgroup only.
Time Frame
14 days after 4th vaccination dose
Title
Neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose.
Description
Neutralizing antibody titre (Virus Neutralisation Assay) against variants of Concern (VOC) 14 days after a 4th vaccination dose, to be determined in a subgroup only.
Time Frame
14 days after 4th vaccination dose
Title
Neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose.
Description
Neutralizing atibody titre (Virus Neutralisation Assay) against wild-type SARS-CoV-2 at 12 months after a 4th vaccination dose, to be determined in a subgroup only.
Time Frame
Up to 12 months after 4th vaccination dose
Title
Neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose.
Description
Neutralizing atibody titre (Virus Neutralisation Assay) against variants of concern at 12 months after a 4th vaccination dose, to be determined in a subgroup only.
Time Frame
Up to 12 months after 4th vaccination dose
Other Pre-specified Outcome Measures:
Title
CD4+ and CD8+ T cell response following 4th vaccination dose
Description
Change in cellular immune response (CD4+ and CD8+ T cell response) measured by qPCR 14 days after 4th vaccination dose, to be determined in a subgroup analysis.
Time Frame
14 days after 4th vaccination dose
Title
Neutralizing antibody titre (Virus Neutralisation Assay) against newly emerging variants in bio-banked samples after 4th vaccination dose.
Description
Neutralizing antibody titre (Virus Neutralisation Assay) against newly emerging variants in bio-banked samples in a subgroup analysis after 4th vaccination dose.
Time Frame
Up to 12 months after 4th vaccination dose
Title
Correlates of humoral immune response, cellular immune response and viral neutralising capacity against SARS-CoV-2 variants of concern (VOC).
Description
Correlates of humoral immune response, cellular immune response and viral neutralising capacity against SARS-CoV-2 variants of concern (VOC), to be determined in a subgroup only.
Time Frame
Up to 12 months after 4th vaccination dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is ≥75 years old). Prior to study entry the subject was vaccinated with one of the following vaccination regimens (1st + 2nd + 3rd dose): BNT162b2 + BNT162b2 + BNT162b2 BNT162b2 + BNT162b2 + mRNA-1273 mRNA-1273 + mRNA-1273 + mRNA-1273 mRNA-1273 + mRNA-1273 + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + BNT162b2 ChAdOx-1-S + ChAdOx-1-S + mRNA-1273 The last dose of the above listed vaccinations must have been administered at least 1 month prior to study entry. Vaccination status should be documented in the source data and will be captured in the eCRF. - Written informed consent from subject has been obtained. Exclusion Criteria: Prior to study entry the subject got vaccinated with a regimen not included in the list given above. Last anti-SARS-CoV-2 vaccine dose administered less than one month prior to study entry. Vaccination against a disease other than COVID-19 within 2 weeks prior to study entry. Only exception: Influenza vaccination which is allowed at any time. Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator. Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to >10 mg/day prednisolone. Subject simultaneously participates in another clinical trials or has participated in the past 30 days. Subjects unable to report solicited adverse events. Subject with any contraindications to the vaccines in the trial. A list of contraindications as listed in the Summary of medicinal Product Characteristics (SmPC, the Fachinformation in Germany), if appropriate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Cornely, Prof
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Cologne
City
Cologne
ZIP/Postal Code
50931
Country
Germany
Facility Name
University Hospital Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Hannover Medical School Hospital
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
Wilton
Country
Ireland
Facility Name
Royal College of Surgeons in Ireland
City
Dublin
ZIP/Postal Code
Dublin 09
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
ZIP/Postal Code
Dublin 4
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland
Facility Name
St. James's Hospital
City
Dublin
ZIP/Postal Code
Dublin 8
Country
Ireland
Facility Name
Inlita JSC
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Helse Bergen HF, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Bellvitge University Hospital
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Reina Sofia University Hospital
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
La Paz University Hospital
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Biodonostia Health Research Institute
City
San Sebastián
ZIP/Postal Code
20014
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
36209129
Citation
Neuhann JM, Stemler J, Carcas A, Frias-Iniesta J, Bethe U, Heringer S, Tischmann L, Zarrouk M, Cuppers A, Konig F, Posch M, Cornely OA. A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults >/=75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network. Trials. 2022 Oct 8;23(1):865. doi: 10.1186/s13063-022-06791-y.
Results Reference
derived

Learn more about this trial

Assessing Immune Response of Different COVID-19 Vaccines in Older Adults

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