Pneumococcal Vaccination of Crohn Patients (PneuVAC)

February 6, 2015 updated by: Statens Serum Institut

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2300
        • Statens Serum Institut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0, 4 weeks post vaccination, 1 year post vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0, 4 weeks post vaccination, 1 year post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Statens Serum Institut

Collaborators

Hvidovre University Hospital
Herlev Hospital

Investigators

  • Principal Investigator: Andreas M Petersen, MD, Hvidovre University Hospital
  • Principal Investigator: Ole Ø Thomsen, MD, Herlev Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJK001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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