COVID-19 VaccinesPhase 4PREPARE-iVACNCT05924685
PREPARE-iVAC Trial
A Phase 4 study testing COVID-19 vaccination in people with COVID-19 Vaccines and Varicella Zoster Vaccine, run by University Medical Center Groningen at 7 sites in Netherlands.
Trial summary
Objective: To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior immunogenicity of COVID-19 vaccination as measured by neutralizing antibody titer against the Omicron XBB.1.5 strain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Vaccines, Varicella Zoster Vaccine, Vaccine Response
- What is being tested?
- COVID-19 vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 7 sitesNetherlands
- Study dates
- 22 Aug 2023to 27 Feb 2024
- Phase
- Phase 4
- 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
- Age ≥ 18 years
- ≥6 months after kidney transplantation
- Maintenance immunosuppressive therapy consisting of either triple or dual therapy including MMF/MPA with a minimum daily dose of 1000 mg (MMF) or 720 mg (MPA) and a CNI
- Eligible for the vaccinations as described by the instructions of the manufacturers of the vaccines (e.g. received 3 previous COVID-19 vaccinations as part of the primary COVID-19 immunisation)
- Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
- Willing to adhere to the protocol and be available during the study period
Who cannot join
- Previous CNI trough levels not sufficient according to the discretion of the treating physician
- More than two previous kidney transplantations
- Calculated level of panel reactive antibodies prior to last transplantation above 85%
- Evidence of DSAs
- Signs of acute rejection during the preceding year
- Multi-organ transplant recipient
Show all 25Show fewer
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s)
- Contra-indications for use of everolimus according to the opinion of the treating physician
- Active COVID-19 disease
- Active malignancy, except non-melanoma skin cancer
- Inherited immune deficiency
- Infection with Human Immunodeficiency Virus (HIV)
- Administration of T-cell, B-cell, or plasma cell depleting antibodies during the last 6 months
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
- Subjects with severe systemic infections, current or within the two weeks prior to randomisation
- Subjects with severe restrictive or obstructive pulmonary disorders
- Subjects with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled
- Subjects with white blood cell (WBC) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3 at last outpatient clinic visit
- Proteinuria > 1 gram/day at last outpatient clinic visit
- Simultaneous participation in another interventional study that will likely influence the study outcomes
- Subject who are actively trying to get pregnant or are pregnant
- Additional exclusion criteria for Part 2:
- Active varicella or herpes zoster disease
- Herpes zoster vaccination with the live attenuated vaccine (Zostavax) or varicella vaccination (Provarivax) during the conduct of the study
- Previous herpes zoster vaccination with the RZV
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Amsterdam University Medical Center
Amsterdam, North Holland
University Medical Center Groningen
Groningen
Leiden University Medical Center
Leiden, South Holland
Maastricht University Medical Center
Maastricht, Limburg
Radboud University Medical Center
Nijmegen, Gelderland
Erasmus Medical Center
Rotterdam, South Holland
University Medical Center Utrecht
Utrecht
About this study
Official title: Prospective Randomized Trial of Everolimus Replacing MMF/MP Acid by the RECOVAC Consortium to Increase VACcine Response in Kidney Transplant Patients
Objective: To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior immunogenicity of COVID-19 vaccination as measured by neutralizing antibody titer against the Omicron XBB.1.5 strain.
Trial design: Multicentre, open-label randomized controlled clinical trial, for a duration of at least 10 weeks with an optional extension to 18 weeks.
Read more
Trial population: Kidney transplant recipients, 18 years or older, who are at least 6 months after transplantation, with a functioning kidney transplant, using MMF/MPA in combination with at least one other immunosuppressant including a calcineurin inhibitor (CNI), with at least 3 previous COVID-19 vaccinations (=basic COVID-19 immunisation).
Interventions:
Patients will be randomized into one of two equally sized groups, with either continuation of their current immunosuppressive regimen including MMF/MPA or replacement of MMF/MPA by everolimus during at least six weeks before until four weeks after the last vaccination. Patients will receive a repeated COVID-19 vaccination with the monovalent Omicron XBB.1.5 vaccine, 28 days thereafter they can opt to also receive two herpes zoster vaccinations with the Recombinant Zoster Vaccine (RZV) with an interval between the first and second dose of 28 days.
Main trial endpoints:
The neutralizing antibody titer against the Omicron XBB.1.5. strain 28 days after monovalent Omicron XBB.1.5 COVID-19 vaccination in patients continuing MMF/MPA compared to patients who switched to everolimus.
Secondary trial endpoints:
- SARS-CoV-2 specific anti-S1 antibody level at 28 and 56 days after COVID-19 vaccination
- Varicella zoster specific anti-gE antibody level 28 days after 1st and 2nd herpes zoster vaccination
- SARS-CoV-2 specific T-cell response 28 days after COVID-19 vaccination
- Varicella zoster specific T-cell response 28 days after 2nd herpes zoster vaccination
- Safety in terms of incidence of acute rejection, kidney function decline, SAEs, AESIs and solicited local and systemic AEs after COVID-19 and herpes zoster vaccination
Read the detailed description
Rationale: The immunogenicity after vaccination against SARS-CoV-2 and other pathogens is diminished in kidney transplant recipients. This patient group therefore remains extremely vulnerable for viral infections despite vaccination. This impaired immune response is related to the use of immunosuppressive agents, especially Mycophenolate Mofetil/Mycophenolic Acid (MMF/MPA). Patients that use everolimus instead of MMF/MPA elicit a higher immune response after vaccination.
Objective
Primary objective:
To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior immunogenicity of COVID-19 vaccination as measured by neutralizing antibody titer against the Omicron XBB.1.5 strain.
Secondary objectives:
- To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior humoral immunogenicity of
- COVID-19 vaccination as measured by SARS-CoV-2 specific anti-S1 antibody levels
- herpes zoster vaccination as measured by varicella zoster specific anti-gE antibody levels
- To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior cellular immunogenicity of
- COVID-19 vaccination as measured by SARS-CoV-2 specific T-cell response
- herpes zoster vaccination as measured by varicella zoster specific T-cell response
- To evaluate safety of replacement of MMF/MPA by everolimus in terms of
- incidence of treated acute rejection, kidney function decline, incidence of serious adverse events (SAEs)
- incidence of adverse events of special interest (AESI) of immunosuppression
- incidence of solicited adverse events (AEs) of COVID-19 vaccination
- incidence of solicited AEs of herpes zoster vaccination
This is a multicentre, open-label, controlled, randomized study to evaluate replacement of MMF/MPA by everolimus in KTR on immunogenicity and safety after vaccination.
The seven participating study sites are Amsterdam UMC, Erasmus MC, Leiden UMC, Maastricht UMC+, Radboudumc, UMC Groningen and UMC Utrecht.
At the first study visit, eligibility for study participation will be checked, blood will be drawn, and participants will subsequently be 1:1 randomised to:
- Continue immunosuppressive therapy with MMF/MPA
- Replace immunosuppressive therapy with MMF/MPA by everolimus
After randomisation, the study will continue in 2 parts:
Part 1 - Run-in and COVID-19 vaccination (≥6 weeks + 28 days) The aim of this phase is to first ensure complete washout of MMF/MPA and attaining optimal trough levels of everolimus in patients randomized to everolimus.
To monitor tolerability, safety and trough levels, participants will be invited at week 1 and week 3 after randomisation for a blood withdrawal and spot urine collection.
At least 6 weeks after randomisation, patients will receive the COVID-19 vaccination (=baseline visit). After 28 days patients will be invited for a study visit for blood withdrawal.
Part 2 (optional) - Herpes zoster vaccination (+56 days) Patients that opted to participate in this part of the study will continue their randomised treatment for the next 56 days. During this period patients will receive 2 herpes zoster vaccinations with an interval of 28 days between each vaccination. At 28 days after the second vaccination patients will be invited for the last study visit for blood withdrawal.
After completion of the study (either 28 days after COVID-19 vaccination or 28 days after the last herpes zoster vaccination) patients will be offered the option to continue everolimus instead of MMF/MPA as part of shared clinical decision making.
- Being tested
- COVID-19 vaccination
- Keywords
- Kidney Transplant Recipients, COVID-19 vaccines, Everolimus, Mycophenolate Mofetil, Varicella Zoster Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccinationBiological
Also called the monovalent Omicron XBB.1.5 COVID-19 mRNA vaccination
Vaccination
| Study group | Role | What they receive |
|---|---|---|
| Continue immunosuppressive therapy with MMF/MPA | Active comparator | Kidney transplant recipients with maintenance therapy, receiving the monovalent Omicron XBB.1.5 COVID-19 mRNA vaccine (Comirnaty, I.M.). Optional to receive the Recombinant Zoster Vaccine (Shingrix, I.M.). Receives: Biological: COVID-19 vaccination |
| Replace immunosuppressive therapy with MMF/MPA by everolimus | Active comparator | Kidney transplant recipients replacing MMF/MPA by everolimus for at least six weeks, receiving the monovalent Omicron XBB.1.5 COVID-19 mRNA vaccine (Comirnaty, I.M.). Optional to receive the Recombinant Zoster Vaccine (Shingrix, I.M.). Receives: Biological: COVID-19 vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virus-neutralizing capacity of SARS-CoV-2 antibodies
The neutralizing antibody titer against the Omicron XBB.1.5 strain
Measured: 28 days after COVID-19 vaccination
Secondary outcomes (7)
SARS-CoV-2 antibody concentration
SARS-CoV-2 specific anti-S1 antibody concentrations in serum
Measured: 28 days after COVID-19 vaccination
SARS-CoV-2 specific T-cell response
SARS-CoV-2 specific T-cell response
Measured: 28 days after COVID-19 vaccination
Varicella Zoster specific antibodies
Concentrations of Varicella Zoster specific anti-gE antibodies
Measured: 28 days after second Varicella Zoster vaccination
Varicella Zoster specific T-cell Response
Varicella Zoster specific T-cell response
Measured: 28 days after second Varicella Zoster vaccination
Solicited local and systemic adverse events
Percentage of participants reporting local reactions (pain at the injection site, redness and swelling) and systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new of worsened muscle pain, and new or worsened joint pain) after COVID-19 and both Varicella Zoster vaccines administration
Measured: Within 7 days after vaccination
Serious adverse events
Percentage of participants with serious adverse events after COVID-19 and both Varicella Zoster vaccines administration, with special interest in treatment of acute rejection.
Measured: Within 84 days after COVID-19 vaccination
Safety of kidney transplant
Change in estimated glomerular filtration rate and proteinuria during the study including creatinine measurements in blood and protein measurements in spot urine.
Measured: From enrollment to 84 days after COVID-19 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start22 Aug 2023
- Primary completion29 Dec 2023
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be 1:1 randomised to: 1. Continue immunosuppressive therapy with MMF/MPA 2. Replace immunosuppressive therapy with MMF/MPA by everolimus
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center, Erasmus Medical Center, UMC Utrecht, Leiden University Medical Center, Maastricht University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Kidney Foundation
- Responsible party
- Sponsor
- Investigators
- Jan-Stephan F Sanders, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924685
- Sponsor's protocol ID
- 11442
- Other IDs
- 2023-503894-39-00, 2023
- Acronym
- PREPARE-iVAC
- Status last verified
- Mar 2024
- First submitted
- 20 Jun 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of this study will be available from the principal investigator, upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Everolimus Replacing MMF/MP Acid by the RECOVAC Consortium to Increase VACcine Response in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT05924685
- Acronym / sponsor ID
- PREPARE-iVAC / 11442
- Keywords
- Kidney Transplant Recipients, COVID-19 vaccines, Everolimus, Mycophenolate Mofetil, Varicella Zoster Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center, Erasmus Medical Center, UMC Utrecht, Leiden University Medical Center, Maastricht University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Kidney Foundation
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 29 Jun 2023 (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.
Objective: To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior immunogenicity of COVID-19 vaccination as measured by neutralizing antibody titer against the Omicron XBB.1.5 strain.
Trial design: Multicentre, open-label randomized controlled clinical trial, for a duration of at least 10 weeks with an optional extension to 18 weeks.
Trial population: Kidney transplant recipients, 18 years or older, who are at least 6 months after transplantation, with a functioning kidney transplant, using MMF/MPA in combination with at least one other immunosuppressant including a calcineurin inhibitor (CNI), with at least 3 previous COVID-19 vaccinations (=basic COVID-19 immunisation).
Interventions:
Patients will be randomized into one of two equally sized groups, with either continuation of their current immunosuppressive regimen including MMF/MPA or replacement of MMF/MPA by everolimus during at least six weeks before until four weeks after the last vaccination. Patients will receive a repeated COVID-19 vaccination with the monovalent Omicron XBB.1.5 vaccine, 28 days thereafter they can opt to also receive two herpes zoster vaccinations with the Recombinant Zoster Vaccine (RZV) with an interval between the first and second dose of 28 days.
Main trial endpoints:
The neutralizing antibody titer against the Omicron XBB.1.5. strain 28 days after monovalent Omicron XBB.1.5 COVID-19 vaccination in patients continuing MMF/MPA compared to patients who switched to everolimus.
Secondary trial endpoints:
- SARS-CoV-2 specific anti-S1 antibody level at 28 and 56 days after COVID-19 vaccination
- Varicella zoster specific anti-gE antibody level 28 days after 1st and 2nd herpes zoster vaccination
- SARS-CoV-2 specific T-cell response 28 days after COVID-19 vaccination
- Varicella zoster specific T-cell response 28 days after 2nd herpes zoster vaccination
- Safety in terms of incidence of acute rejection, kidney function decline, SAEs, AESIs and solicited local and systemic AEs after COVID-19 and herpes zoster vaccination
Detailed description
Rationale: The immunogenicity after vaccination against SARS-CoV-2 and other pathogens is diminished in kidney transplant recipients. This patient group therefore remains extremely vulnerable for viral infections despite vaccination. This impaired immune response is related to the use of immunosuppressive agents, especially Mycophenolate Mofetil/Mycophenolic Acid (MMF/MPA). Patients that use everolimus instead of MMF/MPA elicit a higher immune response after vaccination.
Objective
Primary objective:
To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior immunogenicity of COVID-19 vaccination as measured by neutralizing antibody titer against the Omicron XBB.1.5 strain.
Secondary objectives:
- To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior humoral immunogenicity of
- COVID-19 vaccination as measured by SARS-CoV-2 specific anti-S1 antibody levels
- herpes zoster vaccination as measured by varicella zoster specific anti-gE antibody levels
- To investigate whether replacement of MMF/MPA by everolimus in kidney transplant recipients results in superior cellular immunogenicity of
- COVID-19 vaccination as measured by SARS-CoV-2 specific T-cell response
- herpes zoster vaccination as measured by varicella zoster specific T-cell response
- To evaluate safety of replacement of MMF/MPA by everolimus in terms of
- incidence of treated acute rejection, kidney function decline, incidence of serious adverse events (SAEs)
- incidence of adverse events of special interest (AESI) of immunosuppression
- incidence of solicited adverse events (AEs) of COVID-19 vaccination
- incidence of solicited AEs of herpes zoster vaccination
This is a multicentre, open-label, controlled, randomized study to evaluate replacement of MMF/MPA by everolimus in KTR on immunogenicity and safety after vaccination.
The seven participating study sites are Amsterdam UMC, Erasmus MC, Leiden UMC, Maastricht UMC+, Radboudumc, UMC Groningen and UMC Utrecht.
At the first study visit, eligibility for study participation will be checked, blood will be drawn, and participants will subsequently be 1:1 randomised to:
- Continue immunosuppressive therapy with MMF/MPA
- Replace immunosuppressive therapy with MMF/MPA by everolimus
After randomisation, the study will continue in 2 parts:
Part 1 - Run-in and COVID-19 vaccination (≥6 weeks + 28 days) The aim of this phase is to first ensure complete washout of MMF/MPA and attaining optimal trough levels of everolimus in patients randomized to everolimus.
To monitor tolerability, safety and trough levels, participants will be invited at week 1 and week 3 after randomisation for a blood withdrawal and spot urine collection.
At least 6 weeks after randomisation, patients will receive the COVID-19 vaccination (=baseline visit). After 28 days patients will be invited for a study visit for blood withdrawal.
Part 2 (optional) - Herpes zoster vaccination (+56 days) Patients that opted to participate in this part of the study will continue their randomised treatment for the next 56 days. During this period patients will receive 2 herpes zoster vaccinations with an interval of 28 days between each vaccination. At 28 days after the second vaccination patients will be invited for the last study visit for blood withdrawal.
After completion of the study (either 28 days after COVID-19 vaccination or 28 days after the last herpes zoster vaccination) patients will be offered the option to continue everolimus instead of MMF/MPA as part of shared clinical decision making.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be 1:1 randomised to: 1. Continue immunosuppressive therapy with MMF/MPA 2. Replace immunosuppressive therapy with MMF/MPA by everolimus
| Arm | Type | Receives |
|---|---|---|
| Continue immunosuppressive therapy with MMF/MPA | Active comparator | Biological: COVID-19 vaccinationKidney transplant recipients with maintenance therapy, receiving the monovalent Omicron XBB.1.5 COVID-19 mRNA vaccine (Comirnaty, I.M.). Optional to receive the Recombinant Zoster Vaccine (Shingrix, I.M.). |
| Replace immunosuppressive therapy with MMF/MPA by everolimus | Active comparator | Biological: COVID-19 vaccinationKidney transplant recipients replacing MMF/MPA by everolimus for at least six weeks, receiving the monovalent Omicron XBB.1.5 COVID-19 mRNA vaccine (Comirnaty, I.M.). Optional to receive the Recombinant Zoster Vaccine (Shingrix, I.M.). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- ≥6 months after kidney transplantation
- Maintenance immunosuppressive therapy consisting of either triple or dual therapy including MMF/MPA with a minimum daily dose of 1000 mg (MMF) or 720 mg (MPA) and a CNI
- Eligible for the vaccinations as described by the instructions of the manufacturers of the vaccines (e.g. received 3 previous COVID-19 vaccinations as part of the primary COVID-19 immunisation)
- Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
Key exclusion criteria (25 listed)
- Previous CNI trough levels not sufficient according to the discretion of the treating physician
- More than two previous kidney transplantations
- Calculated level of panel reactive antibodies prior to last transplantation above 85%
- Evidence of DSAs
- Signs of acute rejection during the preceding year
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 |
|---|---|---|
| COVID-19 vaccinationAlso: the monovalent Omicron XBB.1.5 COVID-19 mRNA vaccinationVaccination | Biological | Continue immunosuppressive therapy with MMF/MPA, Replace immunosuppressive therapy with MMF/MPA by everolimus |
Primary outcome
Virus-neutralizing capacity of SARS-CoV-2 antibodies
Time frame: 28 days after COVID-19 vaccination
The neutralizing antibody titer against the Omicron XBB.1.5 strain
7 secondary outcomes
SARS-CoV-2 antibody concentration
Time frame: 28 days after COVID-19 vaccination
SARS-CoV-2 specific T-cell response
Time frame: 28 days after COVID-19 vaccination
Varicella Zoster specific antibodies
Time frame: 28 days after second Varicella Zoster vaccination
Varicella Zoster specific T-cell Response
Time frame: 28 days after second Varicella Zoster vaccination
Solicited local and systemic adverse events
Time frame: Within 7 days after vaccination
Serious adverse events
Time frame: Within 84 days after COVID-19 vaccination
Safety of kidney transplant
Time frame: From enrollment to 84 days after COVID-19 vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No. The data of this study will be available from the principal investigator, upon reasonable request.
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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.
Jan-Stephan F Sanders, MD PhD principal investigator
University Medical Center Groningen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COVID-19 vaccination in people with COVID-19 Vaccines and Varicella Zoster Vaccine, run by University Medical Center Groningen at 7 sites in Netherlands.
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 6 inclusion and 25 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: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Virus-neutralizing capacity of SARS-CoV-2 antibodies (time frame: 28 days after COVID-19 vaccination). 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 4 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.