COVID-19Phase 2BOOST_TXNCT05324319
Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients
A Phase 2 study testing Ad26COVS1, ChAdOx1 SARS2 Vaccine and BNT162B2 in people with COVID-19, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Ad26COVS1, ChAdOx1 SARS2 Vaccine and BNT162B2
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 15 Jun 2021to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- Ad26COVS1, ChAdOx1 SARS2 Vaccine, BNT162B2, mRNA-1273
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26COVS1Drug
Heterologous vaccination
ChAdOx1 SARS2 VaccineDrug
Heterologous vaccination
BNT162B2Drug
Homologous vaccination
mRNA-1273Drug
Homologous vaccination
| Study group | Role | What they receive |
|---|---|---|
| homologous 3rd vaccination (mRNA vaccine) | Active comparator | 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 ) Receives: Drug: BNT162B2; Drug: mRNA-1273 |
| heterologous 3rd vaccination (vector vaccine) | Experimental | participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S) Receives: Drug: Ad26COVS1; Drug: ChAdOx1 SARS2 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion at 4 weeks
number of patients developing SARS-CoV-2 antibodies at 4 weeks after 3rd vaccination
Measured: 4 weeks
Secondary outcomes (4)
Seroconversion at 12 weeks
number of patients developing SARS-CoV-2 antibodies at 12 weeks after 3rd vaccination (> 0.8 BAU/mL)
Measured: 3 months
SARS-CoV-2 antibody levels at 4 weeks
SARS-CoV-2 antibody levels at 4 weeks after the third vaccination
Measured: 4 weeks
SARS-CoV-2 antibody levels at 12 weeks
SARS-CoV-2 antibody levels at 12 weeks after the third vaccination
Measured: 3 months
Seroconversion at 36 weeks
number of patients developing SARS-CoV-2 antibodies at 36 weeks after 3rd vaccination (> 0.8 BAU/mL)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start15 Jun 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Reindl-Schwaighofe, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324319
- Sponsor's protocol ID
- BOOST_TX
- Acronym
- BOOST_TX
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05324319
- Acronym / sponsor ID
- BOOST_TX / BOOST_TX
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| homologous 3rd vaccination (mRNA vaccine) | Active comparator | Drug: BNT162B2, Drug: mRNA-1273Participants 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 Vaccineparticipants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad26COVS1Heterologous vaccination | Drug | heterologous 3rd vaccination (vector vaccine) |
| ChAdOx1 SARS2 VaccineHeterologous vaccination | Drug | heterologous 3rd vaccination (vector vaccine) |
| BNT162B2Homologous vaccination | Drug | homologous 3rd vaccination (mRNA vaccine) |
| mRNA-1273Homologous vaccination | Drug | homologous 3rd vaccination (mRNA vaccine) |
Primary outcome
Seroconversion at 4 weeks
Time frame: 4 weeks
number of patients developing SARS-CoV-2 antibodies at 4 weeks after 3rd vaccination
4 secondary outcomes
Seroconversion at 12 weeks
Time frame: 3 months
SARS-CoV-2 antibody levels at 4 weeks
Time frame: 4 weeks
SARS-CoV-2 antibody levels at 12 weeks
Time frame: 3 months
Seroconversion at 36 weeks
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ad26COVS1, ChAdOx1 SARS2 Vaccine and BNT162B2 in people with COVID-19, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion at 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.