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Influenza Vaccination in Patients With Scleroderma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01002508
Recruitment Status : Unknown
Verified August 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 27, 2009
Last Update Posted : October 27, 2009
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Study Description
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Brief Summary:
The safety and efficacy of vaccination against influenza in patients with scleroderma is not clear. The objective of this study is to assess its safety and efficacy in 50 patients with scleroderma in comparison with 30 controls

Condition or disease Intervention/treatment Phase
Influenza Vaccine in Scleroderma Biological: Influenza vaccine Phase 4

Detailed Description:

Fifty patients with scleroderma and 30 healthy , aged matched controls will participate in the study.

After signing informed consent, all subjects will be vaccinated with the inactivated split virion vaccine which recommended by the WHO this fall.

Patients will be evaluated at weel 0 and 6 weeks later. Clinical evaluation will be based on the modified Rodnan score, number of digital ischemic ulcers, presence of gastrointestinal and respiratory symptoms, number of swollen and tender joints, visual global evaluation of the physician , ESR and CRP Blood with 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 were separated, code labeled, and stored at -20°C until tested. Sera were 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 were 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 were diluted in phosphate buffered saline (PBS) and added to serial dilution of antiserum. The haemagglutinin inhibition titer was 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.

Primary Endpoint of the study : the proportion of patients who achieve a titer of antibodies above 1/40, against each of the antigens included in the vaccine Secondary Endpoint: Safety of the vaccine

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Vaccination Against Influenza in Patients With Scleroderma
Study Start Date : November 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Biological: Influenza vaccine
    One dose of influenza vaccine

Outcome Measures
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Primary Outcome Measures :
  1. The number of subjects who achieve a titer of antibodies above 1/40 [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Number of patients with an increased Rodnan Score [ Time Frame: 6 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients >18 year old age
  • Capable to sign a informed consent
  • Suffering from scleroderma

Exclusion Criteria:

  • Known allergy to influenza vaccine
  • Allergy to eggs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002508


Contacts
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Contact: Ira Litinsky, MD 97236873668 orie@tasmc.health.gov.il
Contact: Ori Elkayam, M.D 97236973668 oribe14@netvision.net.il

Locations
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Israel
Tel Aviv Medical Center
Tel AVIV, Israel, 64239
Contact: Ayelet Brill    972524266894    ayeletb@tasmc.health.gov.il   
Contact: Ori Elkayam    97236973668    oribe14@netvision.net.il   
Principal Investigator: Ira Litinsky, MD         
Sub-Investigator: Ori Elkayam, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
More Information
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Publications:

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Responsible Party: Ira Litinsky, Tel Aviv Medical Center
ClinicalTrials.gov Identifier: NCT01002508    
Other Study ID Numbers: 0344-09
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: August 2009
Keywords provided by Tel-Aviv Sourasky Medical Center:
influenza vaccine scleroderma immunogenicity safety
Additional relevant MeSH terms:
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Influenza, Human
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
 Respiratory Tract Infections
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs