COVID-19 Clinical Trial
— EU-COVAT-1Official 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)
Verified date | November 2023 |
Source | University of Cologne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 Cohorts and arms can be withdrawn or added as deemed necessary according to the criteria specified in this protocol
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Oliver Cornely, MD | European Commission, VACCELERATE |
Germany, Ireland, Lithuania, Norway, Spain,
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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