Influenza Vaccination in Patients Suffering From Fibromyalgia
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- proportion of patients who achieve a titer of antibodies above 1/40, against each of the antigens included in the vaccine
Study Overview
Brief Summary
Fibromyalgia is a clinical syndrome characterized by the presence of chronic widespread pain accompanied by tenderness and fatigue. Central sensitization is considered to be a major pathogenetic feature of fibromyalgia. While the etiology of fibromyalgia is incompletely understood, it is generally considered to result from the interaction between an appropriate genetic background and the exposure of a susceptible individual to various inciting "triggers". These have included among others physical trauma, infection, stress etc.
The possible role of vaccination in causing or exacerbating fibromyalgia has been previously raised. Thus, gulf war syndrome, an entity with considerable clinical overlap with fibromyalgia, has been considered to have a possible link with the exposure to multiple vaccinations. More recently a theory has been advanced regarding the possibility that vaccination - related adjuvants may induce a multisystem disorder characterized by symptoms such as fatigue, cognitive impairment and arthralgia (the so called ASIA syndrome).
The investigators have previously established the safety and efficacy of influenza vaccination in Rheumatoid arthritis patients.
In view of this background it is of considerable clinical importance to ascertain both the efficacy and safety of vaccination in patients suffering from fibromyalgia.
Detailed Description
Fifty patients with fibromyalgia and 30 healthy, age - matched controls will participate in the study.
The classification of fibromyalgia will be performed by applying the 1990 ACR criteria.
After signing informed consent, all subjects will be vaccinated with the inactivated split virion vaccine, recommended by the WHO this fall.
Patients will be evaluated at weeks 0 and 6 weeks later. Clinical evaluation will be based on the Fibromyalgia Impact Questionnaire and the 2010 Fibromyalgia Severity Scale.
ESR and CRP Blood will be collected on the day of vaccination and 6 weeks later.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients >18 year old age
- •Capable to sign a informed consent
- •Suffering from fibromyalgia (ACR criteria)
Exclusion Criteria
- •Known allergy to influenza vaccine
- •Allergy to eggs
Arms & Interventions
Fibromyalgia arm
Patients fulfilling ACR 1990 Criteria for classification of Fibromyalgia, receiving the vaccination.
Intervention: Inactivated split virion Influenza vaccine (Biological)
Heathy controls
Healthy controls receiving Influenza vaccination
Intervention: WHO recommended 2011 Influenza vacccine (Biological)
Outcomes
Primary Outcomes
proportion of patients who achieve a titer of antibodies above 1/40, against each of the antigens included in the vaccine
Time Frame: Six weeks
Secondary Outcomes
- Number of adverse events(Six weeks)
- Clinical changes post - vaccination(Six weeks)