Fibromyalgia SyndromeNCT01465477
Influenza Vaccination in Fibromyalgia Patients
A study testing Inactivated split virion Influenza vaccine and WHO recommended 2011 Influenza vacccine in people with Fibromyalgia Syndrome, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Inactivated split virion Influenza vaccine and WHO recommended 2011 Influenza vacccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 year old age
- Capable to sign a informed consent
- Suffering from fibromyalgia (ACR criteria)
Who cannot join
- Known allergy to influenza vaccine
- Allergy to eggs
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rheumatology Institute, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Jacob N Ablin, MD, 972-3-6973668
Jacob N Ablin, MD
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Inactivated split virion Influenza vaccine, WHO recommended 2011 Influenza vacccine
- Keywords
- Fibromyalgia, Influenza vaccination
- Medical subject headings
- Fibromyalgia, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated split virion Influenza vaccineBiological
WHO recommended 2011 Influenza vaccine
WHO recommended 2011 Influenza vacccineBiological
WHO recommended 2011 Influenza vacccine
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia arm | Experimental | Patients fulfilling ACR 1990 Criteria for classification of Fibromyalgia, receiving the vaccination. Receives: Biological: Inactivated split virion Influenza vaccine |
| Heathy controls | Experimental | Healthy controls receiving Influenza vaccination Receives: Biological: WHO recommended 2011 Influenza vacccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients who achieve a titer of antibodies above 1/40, against each of the antigens included in the vaccine
Measured: Six weeks
Secondary outcomes (2)
Number of adverse events
The occurrence of vaccine - related adverse events (allergic reactions, pain at injection site, fever etc) will be documented.
Measured: Six weeks
Clinical changes post - vaccination
Clinical evaluation of Fibromyalgia patients will be performed on follow up, including a tender point count and documentation of the Fibromyalgia severity scale.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jacob N Ablin, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465477
- Sponsor's protocol ID
- 0332-11-TLV
- Other IDs
- 0332-11-TLV
- Status last verified
- Oct 2011
- First submitted
- 24 Oct 2011
- Last updated
- 4 Nov 2011
- Results posted
- No
Publications
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.
PubMed 21425247Ablin 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.
PubMed 17071055Meroni 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.
PubMed 21051205
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccination in Patients Suffering From Fibromyalgia
- ClinicalTrials.gov ID
- NCT01465477
- Acronym / sponsor ID
- 0332-11-TLV
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia, Influenza vaccination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 4 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia arm | Experimental | Biological: Inactivated split virion Influenza vaccinePatients fulfilling ACR 1990 Criteria for classification of Fibromyalgia, receiving the vaccination. |
| Heathy controls | Experimental | Biological: WHO recommended 2011 Influenza vacccineHealthy controls receiving Influenza vaccination |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >18 year old age
- Capable to sign a informed consent
- Suffering from fibromyalgia (ACR criteria)
Key exclusion criteria (2 listed)
- Known allergy to influenza vaccine
- Allergy to eggs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactivated split virion Influenza vaccineWHO recommended 2011 Influenza vaccine | Biological | Fibromyalgia arm |
| WHO recommended 2011 Influenza vacccineWHO recommended 2011 Influenza vacccine | Biological | Heathy controls |
Primary outcome
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
2 secondary outcomes
Number of adverse events
Time frame: Six weeks
Clinical changes post - vaccination
Time frame: Six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
- Background: PubMed 21425247Elkayam 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.
- Background: PubMed 17071055Ablin 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.
- Background: PubMed 21051205Meroni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob N Ablin, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactivated split virion Influenza vaccine and WHO recommended 2011 Influenza vacccine in people with Fibromyalgia Syndrome, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob N Ablin, MD (97236973668, kobby.ablin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465477, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2011.