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Pneumococcal Vaccination of Crohn Patients (PneuVAC)

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ClinicalTrials.gov Identifier: NCT01947010
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : February 10, 2015
Sponsor:
Collaborators:
Hvidovre University Hospital
Herlev Hospital
Information provided by (Responsible Party):
Statens Serum Institut

Brief Summary:

Inflammatory bowel disease (IBD) are at increased risk of infections. This increased susceptibility to infections is due to the disease itself, but also be-cause many patients with autoimmune conditions are treated with immuno-suppressive drugs, such as azathioprine and or TNF-a inhibitors.

Streptococcus pneumoniae (pneumococcus) is a cause of worldwide morbidity and mortality and one of the most common cause of bacterial meningitis in adults. Infection with pneumococcus can be prevented with vaccination. Two pneumococcal vaccine are used in Denmark, the 23 valent polysaccharide-based vaccine (23PPV) and the 13 valent of conjugate pneumococcal vaccines (PCV13).

In this study the investigators wish to study the effect of pneumococcal vaccination with either PPV23 or PCV13 in IBD patients treated with either TNF-a inhibitors, azathioprine or untreated.


Condition or disease Intervention/treatment Phase
Crohns Disease Biological: Prevenar 13 Biological: Pneumovax Phase 4

Detailed Description:

Patients with autoimmune diseases like inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) are at increased risk of infections. This increased susceptibility to infections is due to the disease itself, but also be-cause many patients with autoimmune conditions are treated with immuno-suppressive drugs. Different drugs are well-known suppressors of the immune system: Prednisolone, Azathioprine, Methotrexate (MTX), TNF-a inhibitors, and the newer biological agents such as, e.g., Rituximab (RTX), which is a drug used in the treatment of RA patients often in combination with MTX. The extent of immunosuppression induced by these therapeutic agents seems to depend, to some extent, on pharmacological dose/response relationships and on the combination of drugs, but individual variability plays a major role as well.

Prophylactic measures such as vaccination, quick upstart of antibiotics in case of fever and general information to patients about how to handle fever etc. are important in order to prevent as many cases of serious infections as possible among patients in immunosuppressive treatment.

Streptococcus pneumoniae is a cause of worldwide morbidity and mortality. Pneumococcal vaccines have been available since the early 1980's. The vaccine which has been licensed for immunization of children >2 years and adults is a polysaccharide-based vaccine (23PPV) consisting of capsule parts of the 23 most frequent serotypes of pneumococci. This vaccine elicits in normal immunocompetent persons a high antibody response, which lasts for approximately 10 years. Because the 23PPV is a polysaccharide-based vaccine, it induces a T-cell independent response with no memory and there-fore with no possibility of boosting. In 2001, the first generation of conjugate pneumococcal vaccines (PCV7) was licensed. In the PCV's, the capsule material from the pneumococci has been conjugated to a protein, which means that the vaccines can elicit a T-cell dependent immune response even in infants giving memory response and booster possibility. This vaccine has been licensed for use in children from 0-5 years, but studies suggest that PCV immunization might be useful in other groups of people as well etc. immunodeficient children and adults (especially now where the second-generation vaccines PCV10, PCV13 have been licensed covering more pneumococcal serotypes).

Some studies have shown that patients treated with immunosuppressive drugs cannot mount a sufficient antibody response upon vaccination whereas other studies suggest that these patient groups do respond to conventional vaccination.

It is recommended in the Danish guidelines for pneumococcal vaccination, that elderly patients with chronic diseases and patients with a decreased immune system are vaccinated against pneumococcal diseases. Accordingly, patients with Crohn's disease treated with TNF-a inhibitors are recommended pneumococcal vaccination.

In this study, the investigators aim to carry out an investigation of the response to pneumococcal vaccination in persons with Crohn's disease treated with TNF-a inhibitors and/or azathioprine, in order to determine if there is a place for the usage of conjugate vaccination in these patient groups.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Pneumococcal Vaccination of Crohn Patients - A Randomized, Non-blinded Phase 4 Clinical Trial With the Purpose of Investigating the Immune Response Against Two Different Pneumococcal Vaccines in Patients With Crohn's Disease
Study Start Date : July 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Active Comparator: Crohn's patients treated with Azathioprine
Vaccination with PPV23 or Vaccination with PCV 13
Biological: Prevenar 13
Biological: Pneumovax
Active Comparator: Crohn's patients treated with Azathioprine and TNFa inhibitors
Vaccination with PPV23 or Vaccination with PCV 13
Biological: Prevenar 13
Biological: Pneumovax
Active Comparator: Crohn's disease patients without treatment
Vaccination with PPV23 or Vaccination with PCV 13
Biological: Prevenar 13
Biological: Pneumovax



Primary Outcome Measures :
  1. Change in antibody titers [ Time Frame: Day 0, 4 weeks post vaccination, 1 year post vaccination ]
    The primary outcome is to detect a difference in antibody change between the two vaccines as a consequence of the vaccination


Secondary Outcome Measures :
  1. Change in antibody titers as a function of Crohns disease treatment [ Time Frame: Day 0, 4 weeks post vaccination, 1 year post vaccination ]
    The secondary outcome is to detect a difference in antibody change between the two vaccines as a function of the treatment for Crohns disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Crohn's disease, receive immunosuppressive treatment or no treatment

Exclusion Criteria:

  • <18 years of age,
  • pregnant,
  • anemia,
  • previously pneumococcus vaccination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947010


Locations
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Denmark
Statens Serum Institut
Copenhagen, Denmark, 2300
Sponsors and Collaborators
Statens Serum Institut
Hvidovre University Hospital
Herlev Hospital
Investigators
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Principal Investigator: Andreas M Petersen, MD Hvidovre University Hospital
Principal Investigator: Ole Ø Thomsen, MD Herlev Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT01947010     History of Changes
Other Study ID Numbers: BJK001
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Keywords provided by Statens Serum Institut:
antibodies
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Azathioprine
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Antirheumatic Agents