Prospective, Multicentre, Open-label Study Evaluating the Immunogenicity and Safety of Influenza Vaccine in Patients With Inflammatory Bowel Disease (IBD) Receiving or Not Immunosuppressive Therapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 228
- Locations
- 1
- Primary Endpoint
- Seroconversion rate
Study Overview
Brief Summary
The primary purpose of the study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) receiving immunosuppressive therapy with patients not receiving immunosuppressants .
The main objective of the study is to evaluate the humoral immunogenicity of influenza vaccination in patients with IBD
Detailed Description
Annual vaccination against influenza is recommended for those at high risk of complications, particularly among patients with immunodeficiency including those resulting from immunosuppressive treatments administered for a chronic inflammatory bowel disease (IBD). However, published data showing that influenza vaccination coverage is low in this population (<30%) due to lack of data on the effectiveness of vaccination in these patients and the theoretical risk of negative impact on the evolution of IBD.
To improve influenza vaccination coverage of the population treated by immunosuppressants for a chronic IBD, it is essential to have data on the effectiveness of vaccination in these populations.
The research aims to evaluate the immunogenicity of influenza vaccination in patients followed for a chronic IBD.
Factors in choice of study population were as follows:
- IBD is a common disease. Among the inflammatory diseases treated with immunosuppressants and reaching patients under 65 years, IBD are among the most frequent. They result from an abnormal immune response to gut flora and their management often requires the prescription of immunosuppressive drugs (azathioprine, methotrexate, in particular) and more recently TNF-blockers;
- the existence of vaccine recommendations published recently for specific patients on immunosuppressive therapy at greatest risk of complications related to influenza;
- the fact that vaccinations have not been implicated in the pathogenesis of the disease;
- data showing that vaccination recommendations are poorly followed in this population. A recently published work found vaccination coverage against influenza of only 28% in a cohort of 169 patients treated for IBD;
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
2
patients with IBD receiving immunosuppressants (TNF blockers excluded) (n=100)
Intervention: Vaccine (Drug)
3
patients with IBD receiving immunosuppressants including TNF blockers (n=100)
Intervention: Vaccine (Drug)
1
patients with IBD not receiving immunosuppressant (n=100)
Intervention: Vaccine (Drug)
4
patients with IBD receiving immunosuppressants including TNF blockers (n=20)
Intervention: Vaccine anti-H1N1 (Biological)
Outcomes
Primary Outcomes
Seroconversion rate
Time Frame: 3-4 weeks after vaccination
Seroconversion rate in the overall population, defined as the geometric mean titers ratio post / pre-vaccination for each of the three vaccine strains
Secondary Outcomes
- Seroconversion factor(3 weeks and 6 months after vaccination)
- Seroprotection rate against the three vaccine strains(3 or 4 weeks after of vaccination)
- Seroprotection rate in the general population(3 weeks and 6 months after vaccination)
- Seroconversion rate, geometric mean titers ratio before and after vaccination by haemagglutination inhibition assay(after 3 weeks of vaccination)
- Comparison of seroprotection rates for each of the three vaccine strains obtained in each of three groups(3 weeks and 6 months of vaccination)
- Comparison of seroconversion factors obtained after 1 or 2 vaccinations in each of three groups of inflammatory bowel disease (IBD) and in the entire population(After 3 weeks of vaccination)
- Number of influenza episodes and confirmed flu during each influenza peak season(6 months after vaccination)
- Occurrence of medical visits, emergency room visits, hospital admissions and deaths throughout the course of the study(18 months after vaccination)
- Occurrence and intensity of local and general adverse events within 5 days after vaccine administration(5 days after vaccination)
- Search of the determining factors to the influenza vaccine response(18 months after vaccination)
- Sub-immunological study(6 months after vaccination)