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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45696

Enrollment

178

Registered

2016-11-24

Start date

2016-12-06

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

antibody response protection after vaccination

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Diagnosis of an immune deficiency disorder - Age

Design outcomes

Primary

Measure	Time frame
The ratio of the anti-pneumococcal antibodies measured before and four to six weeks after pneumococcal vaccination (PCV13 administered at Week 0 and PPV23 administered at Week 8). An adequate response is considered as a 2-fold increase in anti-pneumococcal antibodies.	—

Secondary

Measure	Time frame
The difference in response rates to pneumococcal vaccination between the control and intervention groups.	—

Countries

Netherlands

Outcome results