Kidney TransplantationPhase 4MICHNCT01109914
Mucosal Response in Immunocompromised Host
A Phase 4 study testing Dukoral in people with Kidney Transplantation and Immunity, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The aim of this study is to verify whether vaccination with Dukoral® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor CNI) or mycophenolate mofetil (MMF). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation, Immunity
- What is being tested?
- Dukoral
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Mar 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years of age
- Informed consent
- Above 18 years of age
- Creatinin clearance ≥ 40 ml/min measured in the 6 months prior to inclusion
- Stable renal function for 1 year prior to inclusion
- Stable immunosuppressive regimen of a CNI, MMF or mTORi combined with prednisolone for at least 3 months prior to inclusion
- Informed Consent
Who cannot join
- History of an auto-immune disease (SLE, ANCA associated vasculitis, Goodpasture, Henoch Schonlein, cryoglobulinemia, secondary vasculitis, polyarteritis nodosa and immunodeficiency disorders like IgA deficiency)
- Chronic infection
- Past vaccination with Dukoral or another cholera or ETEC vaccine
- History of infection with Vibrio cholerae
- Episode of diarrhoea in the 6 months prior to inclusion
- Allergy to vaccine-specific components
Show all 24Show fewer
- History of a severe allergic reaction to any vaccine
- Treatment with blood products in the 3 months prior to inclusion
- Current pregnancy or breastfeeding
- Premenopausal women not willing to use contraceptives during the first 60 days after vaccination
- Use of any immunosuppressive drug
- RENAL TRANSPLANT RECIPIENTS
- History of an auto-immune disease (SLE, ANCA associated vasculitis, Goodpasture, Henoch Schonlein, cryoglobulinemia, secondary vasculitis, polyarteritis nodosa and immunodeficiency disorders like IgA deficiency)
- Chronic infection
- Treatment for rejection of the transplant in the past 1 year prior to inclusion
- Past vaccination with Dukoral or another cholera or ETEC vaccine
- History of infection with Vibrio cholerae
- Episode of diarrhoea in the 6 months prior to inclusion
- Allergy to vaccine-specific components
- History of a severe allergic reaction to any vaccine
- Treatment with blood products in the 3 months prior to inclusion
- Current pregnancy or breastfeeding
- Premenopausal women not willing to use contraceptives during the first 60 days after vaccination
- Use of an immunosuppressive drug other than CNI, MMF, mTORi or prednisolone at the the time of inclusion
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden Univeristy Medical Centre
Leiden, South Holland, 2333 ZA
About this study
Official title: Immune Response After Inactivated Oral Cholera Vaccine (Dukoral) in Renal Transplant Recipients
The aim of this study is to verify whether vaccination with Dukoral® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor CNI) or mycophenolate mofetil (MMF).
Read the detailed description
BACKGROUND:
LT-ETEC is the most common cause of travelers' diarrhoea. Dukoral® (SBL Vaccines) reduces the severity and duration of LT-ETEC induced diarrhea. Dehydration due to diarrhea poses a risk to the health of renal transplant recipients. Therefore Dukoral may benefit this group of travelers.
AIM OF THIS STUDY:
Primary objective: To verify whether vaccination with Dukoral® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor (cyclosporine or tacrolimus) or mycophenolate mofetil.
Secondary objective: To evaluate to what extent, the immune response differs, depending on the use of different classes of immunosuppressive drugs (CNI or MMF).
STUDY DESIGN:
Single center interventional study.
Population: The population base of the study consists of adult renal transplant recipients who received their transplant at our medical center. The control population consists of the healthy partners and siblings of the renal transplant recipients. We intend to include 10 healthy volunteers and 60 renal transplant recipients (20 on prednisolone and a CNI and 20 on prednisolone and MMF).
Intervention: Dukoral® (SBL Vaccines) will be administered orally at baseline (day 0) and at day 14.
Laboratory analysis: Serum CTB antibody (ELISA), Vibriocidal assay. The analysis is performed at Crucell.
Statistical analysis: No formal sample-size calculation was performed. The crude outcome estimates will be adjusted for variables that may influence the outcome (age, time after transplantation, past treatment for transplant rejection, current renal function, cumulative prednisolone dose, serum concentration (i.e. area under the curve) of CNI and MMF.
Note: the study intended to also recruit a study arm consisting of patients on a mTORi. Recruitment for this study arm was unsuccesful due to the scarcity of elligible patients.
- Conditions
- Kidney Transplantation, Immunity
- Being tested
- Dukoral
- Keywords
- Renal transplantation, Immunosuppression, ETEC, Dukoral, Vaccination, Immunity, Humoral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DukoralBiological
Two oral doses of Dukoral® (SBL Vaccines) will be administered (day 0 and day 14). Each dosage contains 3 ml of suspension in a vial and 5.6 g of effervescent granules in a sachet. Each dosage (3 ml) contains: A total of 100000 million bacteria of the following strains:
- Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 25x1000 million bacteria*
- Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 25x1000 million bacteria*
- Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 25x1000 million bacteria*
- Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 25x1000 million bacteria*
- Recombinant cholera toxin B subunit (rCTB) 1 mg (produced in V. cholerae O1 Inaba, classical biotype strain 213)
| Study group | Role | What they receive |
|---|---|---|
| Renal transplant recipients (MMF) | Experimental | Renal transplant recipients using prednisolone and mycophenolate mofetil (MMF) but no other immunosuppressive drug.
Intervention: vaccination with Dukoral Receives: Biological: Dukoral |
| Renal transplant recipients (CNI) | Experimental | Renal transplant recipients using prednisolone and a calcineurin inhibitor (cyclosporine or tacrolimus) but no other immunosuppressive drug.
Intervention: vaccination with Dukoral Receives: Biological: Dukoral |
| Healthy volunteers | Experimental | Healthy volunteers (partners, brothers or sisters of the renal transplant recipients).
Intervention: vaccination with Dukoral Receives: Biological: Dukoral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage seroconversion among all renal transplant recipients.
≥3-fold rise in serum anti-CTB antibodies or ≥4-fold rise in serum vibriocidal antibodies.
Measured: day 20-22
Secondary outcomes (1)
Group differences in geometric mean antibody titers after vaccination
post-vaccination anti-rCTB titers, measured by Enzyme Immuno Assay (EIA); post-vaccination serum vibriocidal antibodies, measured in vibriocidal assay.
Measured: day 20-22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Crucell B.V., Leiden, the Netherlands
- Responsible party
- Principal investigator, Darius Soonawala, Leiden University Medical Center
- Investigators
- Leo G Visser, MD PhD, Principal investigator, Leiden University Medical CenterDarius Soonawala, MD, Study director, Leiden University Medical CenterO W Bredewold, MD, Study chair, Leiden University Medical CenterJ W de Fijter, Prof PhD, Study chair, Leiden University Medical CenterMarjolein AC Uijlings, Study chair, Leiden University Medical CenterEmile FF Jonker, MD, Study chair, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109914
- Sponsor's protocol ID
- MICH P10.011
- Acronym
- MICH
- Status last verified
- Mar 2015
- First submitted
- 22 Apr 2010
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jonker EFF, Uijlings MAC, Visser LG, Soonawala D. Comparison of the immunogenicity of Dukoral(R) oral cholera vaccine between renal transplant recipients on either a calcineurin inhibitor or mycophenolate - A controlled trial. Vaccine. 2019 May 21;37(23):3133-3139. doi: 10.1016/j.vaccine.2019.04.010. Epub 2019 Apr 24.
PubMed 31029516
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response After Inactivated Oral Cholera Vaccine (Dukoral) in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT01109914
- Acronym / sponsor ID
- MICH / MICH P10.011
- Conditions
- Kidney Transplantation, Immunity
- Keywords
- Renal transplantation, Immunosuppression, ETEC, Dukoral, Vaccination, Immunity, Humoral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Crucell B.V., Leiden, the Netherlands
- Study start
- Apr 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Apr 2010 (estimated)
- 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.
The aim of this study is to verify whether vaccination with Dukoral® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor CNI) or mycophenolate mofetil (MMF).
Detailed description
BACKGROUND:
LT-ETEC is the most common cause of travelers' diarrhoea. Dukoral® (SBL Vaccines) reduces the severity and duration of LT-ETEC induced diarrhea. Dehydration due to diarrhea poses a risk to the health of renal transplant recipients. Therefore Dukoral may benefit this group of travelers.
AIM OF THIS STUDY:
Primary objective: To verify whether vaccination with Dukoral® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor (cyclosporine or tacrolimus) or mycophenolate mofetil.
Secondary objective: To evaluate to what extent, the immune response differs, depending on the use of different classes of immunosuppressive drugs (CNI or MMF).
STUDY DESIGN:
Single center interventional study.
Population: The population base of the study consists of adult renal transplant recipients who received their transplant at our medical center. The control population consists of the healthy partners and siblings of the renal transplant recipients. We intend to include 10 healthy volunteers and 60 renal transplant recipients (20 on prednisolone and a CNI and 20 on prednisolone and MMF).
Intervention: Dukoral® (SBL Vaccines) will be administered orally at baseline (day 0) and at day 14.
Laboratory analysis: Serum CTB antibody (ELISA), Vibriocidal assay. The analysis is performed at Crucell.
Statistical analysis: No formal sample-size calculation was performed. The crude outcome estimates will be adjusted for variables that may influence the outcome (age, time after transplantation, past treatment for transplant rejection, current renal function, cumulative prednisolone dose, serum concentration (i.e. area under the curve) of CNI and MMF.
Note: the study intended to also recruit a study arm consisting of patients on a mTORi. Recruitment for this study arm was unsuccesful due to the scarcity of elligible patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Renal transplant recipients (MMF) | Experimental | Biological: DukoralRenal transplant recipients using prednisolone and mycophenolate mofetil (MMF) but no other immunosuppressive drug. Intervention: vaccination with Dukoral |
| Renal transplant recipients (CNI) | Experimental | Biological: DukoralRenal transplant recipients using prednisolone and a calcineurin inhibitor (cyclosporine or tacrolimus) but no other immunosuppressive drug. Intervention: vaccination with Dukoral |
| Healthy volunteers | Experimental | Biological: DukoralHealthy volunteers (partners, brothers or sisters of the renal transplant recipients). Intervention: vaccination with Dukoral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Above 18 years of age
- Informed consent
- Above 18 years of age
- Creatinin clearance ≥ 40 ml/min measured in the 6 months prior to inclusion
- Stable renal function for 1 year prior to inclusion
Key exclusion criteria (24 listed)
- History of an auto-immune disease (SLE, ANCA associated vasculitis, Goodpasture, Henoch Schonlein, cryoglobulinemia, secondary vasculitis, polyarteritis nodosa and immunodeficiency disorders like IgA deficiency)
- Chronic infection
- Past vaccination with Dukoral or another cholera or ETEC vaccine
- History of infection with Vibrio cholerae
- Episode of diarrhoea in the 6 months prior to inclusion
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 |
|---|---|---|
| DukoralTwo oral doses of Dukoral® (SBL Vaccines) will be administered (day 0 and day 14). Each dosage contains 3 ml of suspension in a vial and 5.6 g of effervescent granules in a sachet. Each dosage (3 ml) contains: A total of 100000 million bacteria of the following strains: * Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 25x1000 million bacteria* * Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 25x1000 million bacteria* * Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 25x1000 million bacteria* * Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 25x1000 million bacteria* * Recombinant cholera toxin B subunit (rCTB) 1 mg (produced in V. cholerae O1 Inaba, classical biotype strain 213) | Biological | Healthy volunteers, Renal transplant recipients (CNI), Renal transplant recipients (MMF) |
Primary outcome
Percentage seroconversion among all renal transplant recipients.
Time frame: day 20-22
≥3-fold rise in serum anti-CTB antibodies or ≥4-fold rise in serum vibriocidal antibodies.
1 secondary outcome
Group differences in geometric mean antibody titers after vaccination
Time frame: day 20-22
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 26 Mar 2015.
- Derived from this study: PubMed 31029516Jonker EFF, Uijlings MAC, Visser LG, Soonawala D. Comparison of the immunogenicity of Dukoral(R) oral cholera vaccine between renal transplant recipients on either a calcineurin inhibitor or mycophenolate - A controlled trial. Vaccine. 2019 May 21;37(23):3133-3139. doi: 10.1016/j.vaccine.2019.04.010. Epub 2019 Apr 24.
Related trials for Kidney Transplantation
RecruitingEarly Phase 1
Fecal Microbiota Transplantation in Kidney Stone Patients
Kidney Stones, Urinary Stone Disease / Nephrolithiasis
Not yet recruitingPhase 3
To Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
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.
Leo G Visser, MD PhD principal investigator
Leiden University Medical Center
Darius Soonawala, MD study director
Leiden University Medical Center
O W Bredewold, MD study chair
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dukoral in people with Kidney Transplantation and Immunity, run by Leiden University Medical Center at 1 site 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 7 inclusion and 24 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 26 Mar 2015. 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 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?
Percentage seroconversion among all renal transplant recipients. (time frame: day 20-22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01109914, which also lists 1 linked publication.
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 26 Mar 2015.