NCT01947010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

September 9, 2013

Last Update Submit

February 6, 2015

Conditions

Crohns Disease

Keywords

antibodies

Outcome Measures

Primary Outcomes (1)

  • Change in antibody titers

    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 Outcomes (1)

  • Change in antibody titers as a function of Crohns disease treatment

    Day 0, 4 weeks post vaccination, 1 year post vaccination

Study Arms (3)

Crohn's patients treated with Azathioprine

ACTIVE COMPARATOR

Vaccination with PPV23 or Vaccination with PCV 13

Biological: Prevenar 13Biological: Pneumovax

Crohn's patients treated with Azathioprine and TNFa inhibitors

ACTIVE COMPARATOR

Vaccination with PPV23 or Vaccination with PCV 13

Biological: Prevenar 13Biological: Pneumovax

Crohn's disease patients without treatment

ACTIVE COMPARATOR

Vaccination with PPV23 or Vaccination with PCV 13

Biological: Prevenar 13Biological: Pneumovax

Interventions

Prevenar 13BIOLOGICAL
Crohn's disease patients without treatmentCrohn's patients treated with AzathioprineCrohn's patients treated with Azathioprine and TNFa inhibitors
PneumovaxBIOLOGICAL
Crohn's disease patients without treatmentCrohn's patients treated with AzathioprineCrohn's patients treated with Azathioprine and TNFa inhibitors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Statens Serum Institut

Copenhagen, 2300, Denmark

Location

Related Publications (2)

  • Kantso B, Halkjaer SI, Ostergaard Thomsen O, Belard E, Gottschalck IB, Jorgensen CS, Krogfelt KA, Slotved HC, Ingels H, Petersen AM. Persistence of antibodies to pneumococcal conjugate vaccine compared to polysaccharide vaccine in patients with Crohn's disease - one year follow up. Infect Dis (Lond). 2019 Sep;51(9):651-658. doi: 10.1080/23744235.2019.1638519. Epub 2019 Jul 10.

    PMID: 31290715DERIVED

  • Kantso B, Halkjaer SI, Thomsen OO, Belard E, Gottschalck IB, Jorgensen CS, Krogfelt KA, Slotved HC, Ingels H, Petersen AM. Immunosuppressive drugs impairs antibody response of the polysaccharide and conjugated pneumococcal vaccines in patients with Crohn's disease. Vaccine. 2015 Oct 5;33(41):5464-5469. doi: 10.1016/j.vaccine.2015.08.011. Epub 2015 Aug 12.

    PMID: 26275480DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

13-valent pneumococcal vaccinePneumococcal Vaccines

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Andreas M Petersen, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

  • Ole Ø Thomsen, MD

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 20, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

DK(1)