Preventive strategies against SARS-CoV-2 in kidney transplant recipients:Intervention A - vaccination: Study to test if vaccination with Ad26COVS1 or ChAdOx1-S results in a better immune response compared to a third dose of BNT162b2 or mRNA-1273 in kidney transplant recipients who did not develop an immune response following previous vaccination against COVID-19Intervention B - monoclonal SARS-CoV-2 antibody cocktail in kidney transplant recipients not responding to vaccinatio

Phase 1

• Conditions: Intervention A - vaccinationPatients following kidney transplant recipients who do not have an adequate immune response against SARS-CoV-2 following two doses of an mRNA vaccineSubstudy A: kidney transplant recipients who did not develop antibodies after a fourth doseIntervention B - monoclonal antibodiesKidney transpant recipients who do not develop neutralizing antibodies after at least two doses of SARS-CoV-2 vaccine; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-002927-39-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-31
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Intervention A:
•patient has received a kidney transplantation
•full SARS-CoV-2 vaccination with mRNA vaccine (two doses) at least 4 weeks before screening
•> 18 years of age
•no SARS-CoV-2 spike protein antibodies at least 4 weeks after the second dose of an mRNA vaccine

Substudy A:
•no SARS-CoV-2 spike protein antibodies four weeks after the third dose
•Maintenance immunosuppression with mycophenolate or azathioprine

Intervention B:
•Participant has received a kidney transplantation.
•Participant has received at least two doses of a SARS-CoV-2 vaccine.
•> 18 years of age.
•No neutralizing SARS-CoV-2 antibodies at least 4 weeks after the last dose of any SARS-CoV-2 vaccine.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Intervention A:
•acute illness with fever
•Prior documented infection with SARS-CoV-2
•triple anticoagulation therapy
•Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
•Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study
•Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures
• Subject is pregnant or breast feeding

Substudy A:
•SARS-CoV-2 spike protein antibodies four weeks after the 3rd vaccination > 0.8 U/mL

Intervention B:
•Prior documented infection with SARS-CoV-2.
•Triple anticoagulation therapy.
•Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
•Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study.
•Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures.
• Subject is pregnant or breast feeding.
•Prior receipt of any mAbs against COVID19 (licensed or investigational) =30 days before enrolment.
•Administration of immunoglobulins =30 days before enrolment.
•Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified