Influenza Vaccination in Fibromyalgia Patients

NCT01465477 | Unknown

• 1 other identifier: 0332-11-TLV
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia; Influenza vaccination

Outcome Measures

Primary Outcomes (1)

• proportion of patients who achieve a titer of antibodies above 1/40, against each of the antigens included in the vaccine

  Six weeks

Secondary Outcomes (2)

• Number of adverse events

  Six weeks

• Clinical changes post - vaccination

  Six weeks

Study Arms (2)

Fibromyalgia arm

EXPERIMENTAL

Patients fulfilling ACR 1990 Criteria for classification of Fibromyalgia, receiving the vaccination.

Biological: Inactivated split virion Influenza vaccine

Heathy controls

EXPERIMENTAL

Healthy controls receiving Influenza vaccination

Biological: WHO recommended 2011 Influenza vacccine

Interventions

Inactivated split virion Influenza vaccine BIOLOGICAL

WHO recommended 2011 Influenza vaccine

Fibromyalgia arm

WHO recommended 2011 Influenza vacccine BIOLOGICAL

WHO recommended 2011 Influenza vacccine

Heathy controls

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 year old age
• Capable to sign a informed consent
• Suffering from fibromyalgia (ACR criteria)

You may not qualify if:

• Known allergy to influenza vaccine
• Allergy to eggs

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Rheumatology Institute, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (3)

• Elkayam O, Amir S, Mendelson E, Schwaber M, Grotto I, Wollman J, Arad U, Brill A, Paran D, Levartovsky D, Wigler I, Caspi D, Mandelboim M. Efficacy and safety of vaccination against pandemic 2009 influenza A (H1N1) virus among patients with rheumatic diseases. Arthritis Care Res (Hoboken). 2011 Jul;63(7):1062-7. doi: 10.1002/acr.20465.

  PMID: 21425247 BACKGROUND

• Ablin JN, Shoenfeld Y, Buskila D. Fibromyalgia, infection and vaccination: two more parts in the etiological puzzle. J Autoimmun. 2006 Nov;27(3):145-52. doi: 10.1016/j.jaut.2006.09.004. Epub 2006 Oct 30.

  PMID: 17071055 BACKGROUND

• Meroni PL. Autoimmune or auto-inflammatory syndrome induced by adjuvants (ASIA): old truths and a new syndrome? J Autoimmun. 2011 Feb;36(1):1-3. doi: 10.1016/j.jaut.2010.10.004. Epub 2010 Nov 3.

  PMID: 21051205 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Influenza, Human

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Jacob N Ablin, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob N Ablin, MD

CONTACT

97236973668; kobby.ablin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 4, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 4, 2011

Record last verified: 2011-10

Locations

IL (1)