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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05160766
Other study ID # EU-COVAT-1_AGED
Secondary ID 2021-004526-29un
Status Completed
Phase Phase 2
First received
Last updated
Start date November 8, 2021
Est. completion date September 13, 2023

Study information

Verified date November 2023
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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 Cohorts and arms can be withdrawn or added as deemed necessary according to the criteria specified in this protocol


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.


Recruitment information / eligibility

Status Completed
Enrollment 323
Est. completion date September 13, 2023
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 75 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Comirnaty(BTN162b2)
Single booster shot (4th dose) of already approved BioNTech/ Pfizer vaccine that protect against COVID-19 infection
Spikevax (mRNA-1273)
Single booster shot (4th dose) of already approved Moderna vaccine that protect against COVID-19 infection

Locations

Country Name City State
Germany University Hospital Cologne Cologne
Germany University Hospital Frankfurt Frankfurt
Germany Hannover Medical School Hospital Hannover
Ireland Cork University Hospital Cork
Ireland Mater Misericordiae University Hospital Dublin
Ireland Royal College of Surgeons in Ireland Dublin
Ireland St. James's Hospital Dublin
Ireland St. Vincent's University Hospital Dublin
Lithuania Inlita JSC Vilnius
Lithuania Vilnius University Hospital Santaros Klinikos Vilnius
Norway Helse Bergen HF, Haukeland University Hospital Bergen
Spain Hospital Universitari Germans Trias i Pujol Badalona
Spain Bellvitge University Hospital Barcelona
Spain Reina Sofia University Hospital Córdoba
Spain La Paz University Hospital Madrid
Spain Biodonostia Health Research Institute San Sebastián

Sponsors (3)

Lead Sponsor Collaborator
Oliver Cornely, MD European Commission, VACCELERATE

Countries where clinical trial is conducted

Germany,  Ireland,  Lithuania,  Norway,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other CD4+ and CD8+ T cell response following 4th vaccination dose 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. 14 days after 4th vaccination dose
Other Neutralizing antibody titre (Virus Neutralisation Assay) against newly emerging variants in bio-banked samples after 4th vaccination dose. Neutralizing antibody titre (Virus Neutralisation Assay) against newly emerging variants in bio-banked samples in a subgroup analysis after 4th vaccination dose. Up to 12 months after 4th vaccination dose
Other Correlates of humoral immune response, cellular immune response and viral neutralising capacity against SARS-CoV-2 variants of concern (VOC). 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. Up to 12 months after 4th vaccination dose
Primary 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. 14 days after 4th vaccination dose
Secondary 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). Up to 12 months after 4th vaccination dose
Secondary 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. 14 days after 4th vaccination dose
Secondary 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. 14 days after 4th vaccination dose
Secondary 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. Up to 12 months after 4th vaccination dose
Secondary 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. Up to 12 months after 4th vaccination dose
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