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

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ClinicalTrials.gov Identifier: NCT05160766
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : February 10, 2022
Sponsor:
Collaborators:
European Commission
VACCELERATE
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne

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Cohorts and arms can be withdrawn or added as deemed necessary according to the criteria specified in this protocol


Condition or disease Intervention/treatment Phase
Vaccination Reaction COVID-19 Vaccination; Infection Biological: Comirnaty(BTN162b2) Biological: Spikevax (mRNA-1273) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Prevention
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)
Actual Study Start Date : November 8, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Comirnaty-Comirnaty-Comirnaty
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.
Biological: Comirnaty(BTN162b2)
Single booster shot (4th dose) of already approved BioNTech/ Pfizer vaccine that protect against COVID-19 infection
Other Name: BioNTech/ Pfizer

Biological: Spikevax (mRNA-1273)
Single booster shot (4th dose) of already approved Moderna vaccine that protect against COVID-19 infection
Other Name: Moderna

Active Comparator: Spikevax-Spikevax-Spikevax
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.
Biological: Comirnaty(BTN162b2)
Single booster shot (4th dose) of already approved BioNTech/ Pfizer vaccine that protect against COVID-19 infection
Other Name: BioNTech/ Pfizer

Biological: Spikevax (mRNA-1273)
Single booster shot (4th dose) of already approved Moderna vaccine that protect against COVID-19 infection
Other Name: Moderna

Active Comparator: Vaxzevria-Vaxzevria-Spikevax
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.
Biological: Comirnaty(BTN162b2)
Single booster shot (4th dose) of already approved BioNTech/ Pfizer vaccine that protect against COVID-19 infection
Other Name: BioNTech/ Pfizer

Biological: Spikevax (mRNA-1273)
Single booster shot (4th dose) of already approved Moderna vaccine that protect against COVID-19 infection
Other Name: Moderna

Active Comparator: Vaxzevria-Vaxzevria-Comirnaty
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.
Biological: Comirnaty(BTN162b2)
Single booster shot (4th dose) of already approved BioNTech/ Pfizer vaccine that protect against COVID-19 infection
Other Name: BioNTech/ Pfizer

Biological: Spikevax (mRNA-1273)
Single booster shot (4th dose) of already approved Moderna vaccine that protect against COVID-19 infection
Other Name: Moderna

Active Comparator: Spikevax-Spikevax-Comirnaty
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.
Biological: Comirnaty(BTN162b2)
Single booster shot (4th dose) of already approved BioNTech/ Pfizer vaccine that protect against COVID-19 infection
Other Name: BioNTech/ Pfizer

Biological: Spikevax (mRNA-1273)
Single booster shot (4th dose) of already approved Moderna vaccine that protect against COVID-19 infection
Other Name: Moderna

Active Comparator: Comirnaty-Comirnaty-Spikevax
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.
Biological: Comirnaty(BTN162b2)
Single booster shot (4th dose) of already approved BioNTech/ Pfizer vaccine that protect against COVID-19 infection
Other Name: BioNTech/ Pfizer

Biological: Spikevax (mRNA-1273)
Single booster shot (4th dose) of already approved Moderna vaccine that protect against COVID-19 infection
Other Name: Moderna




Primary Outcome Measures :
  1. Immunogenicity response to different mRNA-based vaccines as 4th vaccination dose [ Time Frame: 14 days after 4th dose ]
    Rate of 2-fold antibody titre increase following 4th dose vaccination with BNT162b2 (Comirnaty) and mRNA-1273 (Spikevax), measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus at 14 days after 4th dose (versus immediately before vaccination).


Secondary Outcome Measures :
  1. Antibody titre level against wild-type SARS-CoV-2 after a 4th vaccination dose (second booster) [ Time Frame: Up to 12 months after 4th dose ]
    Antibody titre level at 12 months after a 4th vaccination dose measured by a quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA assay).

  2. Neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose [ Time Frame: Up to 12 months after 4th dose ]
    Neutralizing antibody titre (Virus Neutralisation Assay) against wild-type SARS-CoV-2 at 12 months after a 4th vaccination dose

  3. Neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose. [ Time Frame: Up to 12 months after 4th dose ]
    Neutralizing antibody titre (Virus Neutralisation Assay) against variants of Concern (VOC) at 12 months after a 4th vaccination dose.

  4. Change in neutralizing antibody titre (Virus Neutralisation Assay) after a 4th vaccination dose [ Time Frame: 14 days after 4th dose ]
    Change in neutralizing antibody titre (Virus Neutralisation Assay) against wild-type 14 days after a 4th vaccination dose, to be performed in a subgroup only.

  5. Change in neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern 14 days after a 4th vaccination dose, to be performed in a subgroup only. [ Time Frame: 14 days after 4th ]
    Change in neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern 14 days after a 4th vaccination dose, to be performed in a subgroup only.


Other Outcome Measures:
  1. CD4+ and CD8+ T cell response following 4th vaccination dose (second booster) [ Time Frame: 14 days after 4th dose ]
    Change in cellular immune response (CD4+ and CD8+ T cell response) measured by qPCR 14 days after 4th booster dose in a subgroup analysis.

  2. Neutralizing antibody titre (Virus Neutralisation Assay) against newly emerging Variants of Concern [ Time Frame: Up to 12 months after 4th dose ]
    Neutralizing antibody titre (Virus Neutralisation Assay) against newly emerging variants in bio-banked samples in a subgroup analysis after 4th vaccination dose.

  3. Correlates of immune response after 4th vaccination dose against SARS-CoV-2 Variants of Concern (VOC). [ Time Frame: Up to 12 months after 4th dose ]
    Correlates of humoral immune response, cellular immune response and viral neutralising capacity against SARS-CoV-2 variants of concern (VOC).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05160766


Contacts
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Contact: Project Manager University of Cologne +49 221 47885523 eucovat-1-aged@vaccelerate.eu
Contact: Head Office University Hospital of Cologne +49 221 478 0

Locations
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Germany
University Hospital Cologne Recruiting
Cologne, Germany, 50931
Contact: Oliver Cornely, Prof    +49 221 4788 5523    oliver.cornely@uk-koeln.de   
Sponsors and Collaborators
Oliver Cornely, MD
European Commission
VACCELERATE
Investigators
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Principal Investigator: Oliver Cornely, Prof University of Cologne
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Responsible Party: Oliver Cornely, MD, Principal Coordinating Investigator, University of Cologne
ClinicalTrials.gov Identifier: NCT05160766    
Other Study ID Numbers: EU-COVAT-1_AGED
2021-004526-29 ( EudraCT Number )
uni-koeln-4602 ( Other Identifier: University of Cologne )
First Posted: December 16, 2021    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: January 2022

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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
Keywords provided by Oliver Cornely, MD, University of Cologne:
SARS-CoV-2
COVID-19
Vaccination
Immunisation
Comirnaty
Spikevax
Booster
Elderly
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases