The antibody response to pneumococcal vaccination in patients with inflammatory bowel disease patients treated with immunosuppressive agents

Phase 4

Completed

• Conditions: antibody response; protection after vaccination; 10017969; 10027665

• Registration Number: NL-OMON45696
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 178

Inclusion Criteria

- Age > 18 years old
- On treatment with an immunosuppressive agent or planned treatment start with a TNF-alpha inhibitor within 3 months after recruitment
- Indication for pneumococcal vaccination (PCV13 plus PPV23)
- Able to give informed consent
- Control group: diagnosed with IBD, not treated with immunosuppressives.

Exclusion Criteria

- Diagnosis of an immune deficiency disorder
- Age < 18 years
- Control group: treatment with immunosuppressive drugs

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The ratio of the anti-pneumococcal antibodies measured before and four to six<br /><br>weeks after pneumococcal vaccination (PCV13 administered at Week 0 and PPV23<br /><br>administered at Week 8). An adequate response is considered as a 2-fold<br /><br>increase in anti-pneumococcal antibodies. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The difference in response rates to pneumococcal vaccination between the<br /><br>control and intervention groups. </p><br>