MedTrace Logo

Mucosal Response in Immunocompromised Host

NCT01109914 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2015-03-26

No results posted yet for this study

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).

Conditions

  • Kidney Transplantation
  • Immunity

Interventions

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)

Sponsors & Collaborators

  • Crucell B.V., Leiden, the Netherlands

    collaborator UNKNOWN

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • 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

  • Marjolein AC Uijlings · Leiden University Medical Center

  • Emile FF Jonker, MD · Leiden University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01109914 on ClinicalTrials.gov