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
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• COVID-19

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