Mucosal Response in Immunocompromised Host

NCT01109914 | Completed Phase 4

• 1 other identifier: MICH P10.011
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Renal transplantation; Immunosuppression; ETEC; Dukoral; Vaccination; Immunity, Humoral

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Group differences in geometric mean antibody titers after vaccination

  day 20-22

Study Arms (3)

Renal transplant recipients (MMF)

EXPERIMENTAL

Renal transplant recipients using prednisolone and mycophenolate mofetil (MMF) but no other immunosuppressive drug. Intervention: vaccination with Dukoral

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

Biological: Dukoral

Healthy volunteers

EXPERIMENTAL

Healthy volunteers (partners, brothers or sisters of the renal transplant recipients). Intervention: vaccination with Dukoral

Biological: Dukoral

Interventions

Dukoral BIOLOGICAL

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)

Healthy volunteers; Renal transplant recipients (CNI); Renal transplant recipients (MMF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 18 years of age
• Informed consent

You may not qualify if:

• 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
• Allergy to vaccine-specific components
• History of a severe allergic reaction to any vaccine
• 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
• Above 18 years of age
• Informed Consent
• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Crucell B.V., Leiden, the Netherlands: collaborator

Study Sites (1)

Leiden Univeristy Medical Centre

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 31029516 DERIVED

MeSH Terms

Interventions

Dukoral

Study Officials

• Leo G Visser, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• Darius Soonawala, MD

  Leiden University Medical Center

  STUDY DIRECTOR

• O W Bredewold, MD

  Leiden University Medical Center

  STUDY CHAIR

• J W de Fijter, Prof PhD

  Leiden University Medical Center

  STUDY CHAIR

• Marjolein AC Uijlings

  Leiden University Medical Center

  STUDY CHAIR

• Emile FF Jonker, MD

  Leiden University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 23, 2010
• Study Start: April 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

NL (1)