NCT01109914

Mucosal Response in Immunocompromised Host

Immune Response After Inactivated Oral Cholera Vaccine (Dukoral) in Renal Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
BIOLOGICAL	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)

Timeline

• Start date: 2010-04-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2010-04-23
• Last updated: 2015-03-26

Locations

1 site across 1 country: Netherlands