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

NCT05324319 — Phase 2, Unknown, 200 participants, Medical University of Vienna

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Single Blinded Randomized Controlled Trial on BNT162b2 or mRNA-1273 (mRNA) vs Ad26COVS1 or ChAdOx1-S (Viral Vector) for Third Vaccination in Kidney Transplant Recipients Without SARS-CoV-2 Spike Protein Antibodies Following Full Vaccination

Registry	NCT05324319, acronym BOOST_TX
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	200 (Actual)
Sponsor	Medical University of Vienna (Other)
Conditions	COVID-19
Interventions	Ad26COVS1, ChAdOx1 SARS2 Vaccine, BNT162B2, mRNA-1273 (Drug)
Dates	start 2021-06-15, primary completion 2022-07-31 (estimated), completion 2022-12-31 (estimated), first posted 2022-04-12, last updated 2022-04-20
Locations	1 site in Austria

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
homologous 3rd vaccination (mRNA vaccine)	Active comparator	Drug: BNT162B2; Drug: 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 )
heterologous 3rd vaccination (vector vaccine)	Experimental	Drug: Ad26COVS1; Drug: ChAdOx1 SARS2 Vaccine	participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S)

Ad26COVS1 (Drug): Heterologous vaccination
ChAdOx1 SARS2 Vaccine (Drug): Heterologous vaccination
BNT162B2 (Drug): Homologous vaccination
mRNA-1273 (Drug): Homologous vaccination

+Outcome measures

Primary outcomes

Seroconversion at 4 weeks [4 weeks]: number of patients developing SARS-CoV-2 antibodies at 4 weeks after 3rd vaccination

Secondary outcomes

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
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)

+Eligibility

Sex: All, ages: 18 Years to any

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

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

+Locations (1)

Facility	City	Country	Status
Medicial University of Vienna	Vienna	Austria