Influenza Vaccination in Fibromyalgia Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01465477
First received: October 24, 2011
Last updated: November 1, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Fibromyalgia Syndrome
Biological: Inactivated split virion Influenza vaccine
Biological: WHO recommended 2011 Influenza vacccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influenza Vaccination in Patients Suffering From Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    The occurrence of vaccine - related adverse events (allergic reactions, pain at injection site, fever etc) will be documented.

  • Clinical changes post - vaccination [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Clinical evaluation of Fibromyalgia patients will be performed on follow up, including a tender point count and documentation of the Fibromyalgia severity scale.


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibromyalgia arm
Patients fulfilling ACR 1990 Criteria for classification of Fibromyalgia, receiving the vaccination.
Biological: Inactivated split virion Influenza vaccine
WHO recommended 2011 Influenza vaccine
Experimental: Heathy controls
Healthy controls receiving Influenza vaccination
Biological: WHO recommended 2011 Influenza vacccine
WHO recommended 2011 Influenza vacccine

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.

The immunogenicity of the vaccine will be tested by Haemagglutination inhibition (HI) test.

Influenza virus has two important surface glycoproteins: the haemagglutinin (HA) and the neuraminidase (NA). Antigenic classification and subtyping of influenza viruses is based on these two glycoproteins. HA plays a key role in virus cell entry by binding to cell surface receptors, which are found also on red blood cells of certain species. Binding to red cells results in haemagglutination, which can be observed as a carpet of agglutinated red cells at the bottom of a tube or microtitre well. In the HI test, antibody directed against the viral haemagglutinins block the virus from binding to the blood cells and thus inhibits the haemagglutination reaction.

The pre- and post immunization HI antibodies were tested at the Central Virology Laboratory of the Israeli Ministry of Health using the HI test according to a standard WHO procedure 16. Sera will be separated, code labeled, and stored at -20°C until tested. Sera will be treated with receptor destroying enzyme cholera filtrate to remove non-specific inhibitors, and with Turkey red blood cells to remove non-specific agglutinins. The treated sera will be tested by HI test against the three antigens included in the vaccine: A/California (CAL), A/Wisconsin and B/Malaysia. The working dilution (test dose) of each antigen contained four haemagglutinin units in 25 µl of antigen. Test doses will be diluted in phosphate buffered saline (PBS) and added to serial dilution of antiserum. The haemagglutinin inhibition titer will be determined as the highest dilution of serum that completely inhibits haemagglutination of red blood cells.

The titer of an antiserum not showing any inhibition will be recorded as <10. Humoral response will be defined as either a fourfold or more rise in titer, or a rise from a non-protective baseline level of <1/40 to 1/40 in HI antibodies four weeks after vaccination 17,18. Geometric mean titers of antibody will be calculated to assess the immunity of the whole group.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465477

Contacts
Contact: Jacob N Ablin, MD 97236973668 kobby.ablin@gmail.com

Locations
Israel
Rheumatology Institute, Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Jacob N Ablin, MD    972-3-6973668      
Principal Investigator: Jacob N Ablin, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Jacob N Ablin, MD Tel-Aviv Sourasky Medical Center
  More Information

Publications:
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01465477     History of Changes
Other Study ID Numbers: 0332-11-TLV, 0332-11-TLV
Study First Received: October 24, 2011
Last Updated: November 1, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Fibromyalgia
Influenza vaccination

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Influenza, Human
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014