Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment o… (NCT02240888) | Clinical Trial Compass
CompletedNot Applicable
Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response
Sweden300 participantsStarted 2011-10
Plain-language summary
The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage, smoking habits and alcohol consumption.
Exclusion Criteria:
* age \<18 years;
* pregnancy,
* known intolerance of vaccine,
* ongoing infection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This VACCIMIL study looked at how antirheumatic medications affect antibody response to vaccines in conditions like RA, lupus, vasculitis, scleroderma, and Sjögren's — based on its findings, do you think my specific medication could be reducing how well my vaccines are working?
2Since this trial has already completed, has any of its data changed your recommendations about the timing or type of vaccines you suggest for patients on my treatment regimen?
3The study measured antibody responses across several different autoimmune conditions — does my particular diagnosis put me at higher or lower risk of a weakened vaccine response compared to other patients in that study?
4Given what this research found about antirheumatic drugs and vaccine effectiveness, should we consider scheduling any of my vaccinations at a specific point in my treatment cycle — for example, before starting or between doses of my medication?
5Are there any vaccines this study highlighted as being particularly affected by immunosuppressive treatments, and should we prioritize checking whether I'm adequately protected against those specific infections?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
antibody response following vaccination
Timeframe: 4-6 weeks after pneumococcal and influenza vaccination