Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients

Phase 2

• Conditions: COVID-19
• Interventions: Drug: BNT162B2; Drug: Ad26COVS1; Drug: mRNA-1273; Drug: ChAdOx1 SARS2 Vaccine

• Registration Number: NCT05324319
• Lead Sponsor: Medical University of Vienna

Brief Summary

Randomized-controlled trial comparing homologous (mRNA vaccine) vs. heterologous (vector vaccine) for third SARS-CoV-2 vaccine dose in kidney transplant recipients not responding to initial prime-boost vaccination with an mRNA vaccine.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Status Verified: 2022-04
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-12
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-20
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
homologous 3rd vaccination (mRNA vaccine)	mRNA-1273	Participants will receive a third SARS-CoV-2 vaccination with the same mRNA vaccine they received for the initial prime-boost vaccination (BNT162b2 or mRNA-1273 )
homologous 3rd vaccination (mRNA vaccine)	BNT162B2	Participants will receive a third SARS-CoV-2 vaccination with the same mRNA vaccine they received for the initial prime-boost vaccination (BNT162b2 or mRNA-1273 )
heterologous 3rd vaccination (vector vaccine)	ChAdOx1 SARS2 Vaccine	participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S)
heterologous 3rd vaccination (vector vaccine)	Ad26COVS1	participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S)

Primary Outcome Measures

Name	Time	Method
Seroconversion at 4 weeks	4 weeks	number of patients developing SARS-CoV-2 antibodies at 4 weeks after 3rd vaccination

Secondary Outcome Measures

Name	Time	Method
SARS-CoV-2 antibody levels at 12 weeks	3 months	SARS-CoV-2 antibody levels at 12 weeks after the third vaccination
Seroconversion at 36 weeks	6 months	number of patients developing SARS-CoV-2 antibodies at 36 weeks after 3rd vaccination (\> 0.8 BAU/mL)
Seroconversion at 12 weeks	3 months	number of patients developing SARS-CoV-2 antibodies at 12 weeks after 3rd vaccination (\> 0.8 BAU/mL)
SARS-CoV-2 antibody levels at 4 weeks	4 weeks	SARS-CoV-2 antibody levels at 4 weeks after the third vaccination

Trial Locations

Locations (1)

Medicial University of Vienna; 🇦🇹 Vienna, Austria