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NCT05324319 Clinical Trial

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

COVID-19 Clinical Trial

— BOOST_TX  

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05324319
Other study ID # BOOST_TX
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 15, 2021
Est. completion date December 31, 2022

Study information
Verified date April 2022
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date December 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Austria Medicial University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Seroconversion at 4 weeks number of patients developing SARS-CoV-2 antibodies at 4 weeks after 3rd vaccination 4 weeks
Secondary Seroconversion at 12 weeks number of patients developing SARS-CoV-2 antibodies at 12 weeks after 3rd vaccination (> 0.8 BAU/mL) 3 months
Secondary SARS-CoV-2 antibody levels at 4 weeks SARS-CoV-2 antibody levels at 4 weeks after the third vaccination 4 weeks
Secondary SARS-CoV-2 antibody levels at 12 weeks SARS-CoV-2 antibody levels at 12 weeks after the third vaccination 3 months
Secondary Seroconversion at 36 weeks number of patients developing SARS-CoV-2 antibodies at 36 weeks after 3rd vaccination (> 0.8 BAU/mL) 6 months
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