Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients
BOOST_TX
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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Jun 2021
Longer than P75 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2021
CompletedFirst Submitted
Initial submission to the registry
April 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 20, 2022
April 1, 2022
1.1 years
April 4, 2022
April 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Seroconversion at 4 weeks
number of patients developing SARS-CoV-2 antibodies at 4 weeks after 3rd vaccination
4 weeks
Secondary Outcomes (4)
Seroconversion at 12 weeks
3 months
SARS-CoV-2 antibody levels at 4 weeks
4 weeks
SARS-CoV-2 antibody levels at 12 weeks
3 months
Seroconversion at 36 weeks
6 months
Study Arms (2)
homologous 3rd vaccination (mRNA vaccine)
ACTIVE COMPARATORParticipants 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)
EXPERIMENTALparticipants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicial University of Vienna
Vienna, 1090, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 4, 2022
First Posted
April 12, 2022
Study Start
June 15, 2021
Primary Completion
July 31, 2022
Study Completion
December 31, 2022
Last Updated
April 20, 2022
Record last verified: 2022-04