Influenza Vaccination in Fibromyalgia Patients

November 1, 2011 updated by: Tel-Aviv Sourasky Medical Center

Influenza Vaccination in Patients Suffering From Fibromyalgia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Rheumatology Institute, Tel Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: Six weeks
The occurrence of vaccine - related adverse events (allergic reactions, pain at injection site, fever etc) will be documented.
Six weeks
Clinical changes post - vaccination
Time Frame: Six weeks
Clinical evaluation of Fibromyalgia patients will be performed on follow up, including a tender point count and documentation of the Fibromyalgia severity scale.
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Jacob N Ablin, MD, Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

November 4, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0332-11-TLV (Registry Identifier: Tel Aviv Medical Center IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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