Primary objective: to determine the vaccine efficacy of PCV13 plus PPV23 (2-month series) in cases, i.e. IBD patients treated with immunosuppressive agents, vs controls. Secondary objectives: - To assess if the use of a TNF-alpha inhibitor affects…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Immune disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
The difference in response rates to pneumococcal vaccination between the
control and intervention groups.
Background summary
Immunosuppressive agents form a major component in the treatment of
inflammatory bowel disease (IBD). Immunosuppressive agents falls apart in three
main categories, i.e. corticosteroids, disease-modifying anti rheumatic drugs
(DMARDs) (1). The mechanism of action of corticosteroids is blockage of the
early manifestations of inflammation such as vasodilation, vascular
permeability and infiltration of neutrophils. DMARDs suppress the immune system
by inhibiting proliferation and activation of lymphocytes. TNF-alpha inhibitors
are the principle biologicals in the treatment of IBD; it has been demonstrated
that TNF-alpha plays a crucial role in the pathophysiology of IBD (1, 2).
However, immunosuppressive agents increase the risk of infection, notably
TNF-alpha inhibitors strongly suppress the immune system (3-6). Therefore,
according to European and American guidelines, pneumococcal vaccination is
indicated for IBD patients treated with immunosuppressive drugs to prevent
pneumococcal infection (4, 5).
The suppressed state of the immune system impairs the antibody response to
vaccination, though there are only few data available on the efficacy of
pneumococcal vaccines in immunocompromised populations. Some investigators
studied the antibody response in inflammatory bowel disease (IBD) patients on
immunosuppressive agents after vaccination with the 23-valent pneumococcal
polysaccharide vaccine (PPV23) (3, 7, 8); and found lower response rates
(57.6%) among patients treated with anti-TNF compared to IBD patients only
treated with mesalazine (response rates 88.6%) (7). However, to the best of our
knowledge, vaccine efficacies of PCV-13 plus PPV-23both (in series whereby the
PPV-23 is administered two months after the PCV-13) in immunosuppressed
patients with IBD has not been evaluated systematically to date. Furthermore,
the ideal time interval between vaccination and treatment initiation with
anti-TNF to reach the best antibody response remains to be elucidated.
We hypothesize the following:
Hypothesis 1: IBD patients treated with immunosuppressive agents have a
diminished anti-pneumococcal antibody response to pneumococcal vaccination.
Hypothesis 2: Use of a TNF-alpha inhibitor is associated with a lower antibody
response after pneumococcal vaccination than use of (DMARDs) and/or
corticosteroids. Use of either high dose monotherapy with a TNF-alpha
inhibitor, or use of standard dose TNF-alpha inhibitor plus additional
immunosuppressive drugs, is associated with an even lower antibody response
after pneumococcal vaccination.
Hypothesis 3: A longer time-interval between pneumococcal vaccination and
treatment initiation with TNF-alpha inhibitors is associated with a better
antibody response.
Study objective
Primary objective: to determine the vaccine efficacy of PCV13 plus PPV23
(2-month series) in cases, i.e. IBD patients treated with immunosuppressive
agents, vs controls.
Secondary objectives:
- To assess if the use of a TNF-alpha inhibitor affects the anti-pneumococcal
antibody response in a different way than DMARDs and/or corticosteroids do and
if either increased dose monotherapy with a TNF-alpha inhibitor further affects
the immune response.
- To determine the ideal time-interval between pneumococcal vaccination and
treatment initiation with TNF-alpha inhibitors to reach an adequate antibody
response.
Study design
Prospective cohort study.
Study burden and risks
Participants do not benefit directly from participation in this study except
for that appropriate vaccination according to guidelines is warranted and
safeguarded. However, the control group will be better informed on the result
of their pneumococcal vaccination because according to routine procedures, the
anti-pneumococcal titre would not have been assessed. The additional risk of
participation is limited to the drawing of two blood samples (10mL each) at two
different time points and only applies to the control group, as for IBD
patients the titre assessment belongs to the standard procedure.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58768.018.16 |
| OMON | NL-OMON29135 |