NCT01109914|CompletedPhase 4
Mucosal Response in Immunocompromised Host
MICH
Immune Response After Inactivated Oral Cholera Vaccine (Dukoral) in Renal Transplant Recipients
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MICH
Immune Response After Inactivated Oral Cholera Vaccine (Dukoral) in Renal Transplant Recipients
Sponsor study identifier
interventional
51
1 country
1
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
April 22, 2010
Actual (reported)April 23, 2010
Actual (reported)March 2015
Actual (reported)March 2015
Actual (reported)Percentage seroconversion among all renal transplant recipients.
≥3-fold rise in serum anti-CTB antibodies or ≥4-fold rise in serum vibriocidal antibodies.
day 20-22
Group differences in geometric mean antibody titers after vaccination
day 20-22
Renal transplant recipients using prednisolone and mycophenolate mofetil (MMF) but no other immunosuppressive drug. Intervention: vaccination with Dukoral
Renal transplant recipients using prednisolone and a calcineurin inhibitor (cyclosporine or tacrolimus) but no other immunosuppressive drug. Intervention: vaccination with Dukoral
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Leiden Univeristy Medical Centre
Leiden, South Holland, 2333 ZA, Netherlands
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.
Leo G Visser, MD PhD
Leiden University Medical Center
Darius Soonawala, MD
Leiden University Medical Center
O W Bredewold, MD
Leiden University Medical Center
J W de Fijter, Prof PhD
Leiden University Medical Center
51 participants (actual enrollment reported by the registry).
First Submitted
April 22, 2010
First Posted
April 23, 2010
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Healthy volunteers (partners, brothers or sisters of the renal transplant recipients). Intervention: vaccination with Dukoral
Contact the study team to confirm eligibility.
Marjolein AC Uijlings
Leiden University Medical Center
Emile FF Jonker, MD
Leiden University Medical Center
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
March 26, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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