A multinational, phase 2, randomised, adaptive protocol to assess immune response and side effects of different COVID-19 vaccines given in older adults (75 years and older) already vaccinated against SARS-CoV-2

Phase 1

Conditions: Prevention of COVID-19 infection
MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865
MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865
MedDRA version: 24.0Level: LLTClassification code 10085559Term: Revaccination with different COVID-19 vaccineSystem Organ Class: 100000004865
MedDRA version: 23.0Level: LLTClassification code 10084462Term: SARS-CoV-2 vaccinationSystem Organ Class: 100000004865
MedDRA version: 23.0Level: LLTClassification code 10084463Term: SARS-CoV-2 immunisationSystem Organ Class: 100000004865
MedDRA version: 23.0Level: LLTClassification code 10084466Term: SARS-CoV-2 immunizationSystem Organ Class: 100000004865
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2021-004526-29-NO

Lead Sponsor: niversity of Cologne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

•Subject is =75 years old.
•For study entry in Part B the subject was vaccinated with one of the following vaccination regimens (1st + 2nd + 3rd dose):
oBNT162b2 + BNT162b2 + BNT162b2
oBNT162b2 + BNT162b2 + mRNA-1273
omRNA-1273 + mRNA-1273 + mRNA-1273
omRNA-1273 + mRNA-1273 + BNT162b2
oChAdOx-1-S + ChAdOx-1-S + BNT162b2
oChAdOx-1-S + ChAdOx-1-S + mRNA-1273

•The last dose of the above 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.
•No contra-indication against any of the vaccine products in the trial.
•Written informed consent from subject has been obtained.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

•Prior to study entry the subject got vaccinated with a regimen not included in the above list.
•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.
•Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to >10 mg/day prednisolone.
•Subject participates or participated in Part A of this trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the immune response between treatment arms after a 4th vaccination dose against SARS-CoV-2.;Secondary Objective: • To compare the humoral response against wild-type SARS-CoV-2 between treatment arms after a 4th vaccination dose against SARS-CoV-2.<br>•To evaluate descriptively the humoral response against SARS-CoV-2 variants of concern between treatment arms after a 4th vaccination dose against SARS-CoV-2.<br>•To evaluate descriptively the long-term humoral immune response of 4th vaccination dose against SARS-CoV-2.;Primary end point(s): •Rate of 2-fold antibody titre increase 14 days after the 4th vaccination dose measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wild-type virus.;Timepoint(s) of evaluation of this end point: 14 days after IMP administration

Secondary Outcome Measures

Name	Time	Method

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