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Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases

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ClinicalTrials.gov Identifier: NCT03540823
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:

Studies in the literature have shown reduced effectiveness of influenza A (H3N2) virus vaccine (20-40%) when compared to A (H1N1) and influenza B. This reduction in efficacy may partly result of the need to propagate A (H3N2) virus into egg components for the preparation of the vaccine. Other factors that may also contribute to the reduction of efficacy against A (H3N2) viruses include the high level of genetic diversity and the rate of rapid evolution of this particular virus subtype and the modification of the immune response to the vaccine secondary of prior infection or vaccination.

Vaccine efficacy studies are required to verify the immunogenicity of the H3N2 influenza vaccine in immunosuppressed patients with rheumatologic disease. In addition, it is relevant to evaluate the safety of the vaccine in this population as well as the possibility of reactivation of the rheumatologic disease itself. The objectives of this study are to evaluate the immunogenicity of the H3N2 component of the inactivated and fragmented influenza vaccine in patients with two systemic autoimmune rheumatic diseases (Systemic Lupus Erythematosus - Adult and Juvenile, Primary Sjögren's Syndrome).


Condition or disease Intervention/treatment Phase
Systemic Lupus Sjogren's Syndrome Biological: Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : June 23, 2018
Estimated Study Completion Date : August 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with rheumatic diseases
Patients with diagnosis of adult and juvenile systemic lupus erythematosus (SLE and JSLE) and Sjogren syndrome (SSp)
Biological: Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)
Single dose of Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)

Healthy controls
Healthy children and adults
Biological: Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)
Single dose of Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)




Primary Outcome Measures :
  1. Number of participants with seroprotection and seroconversion after Influenza vaccine [ Time Frame: 30 days ]
    Immunogenicity (seroprotection and seroconversion) of the H3N2 component of the inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus) will be evaluated by haemagglutination inhibition (HI) assay


Secondary Outcome Measures :
  1. Number of participants with vaccine-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 30 days ]
    Patients and healthy controls are instructed to note all symptoms in a standardized diary during study period, such as pruritus, local pain, erythema, induration at the site of the vaccine, fever, chills, headache, myalgia, arthralgia and diarrhea. Signs of airway infections (cough, sputum, sore throat, nasal congestion or expectoration), fever (axillary temperature> 37.8 °C), need for hospitalizations, severity of infections, sick days, absenteeism at work, and treatment received for infections. Serious adverse events will be defined as those resulting in hospitalization or death. Number of participants with vaccine-related adverse events will be assessed by CTCAE v4.0 and the following reference: "Saad CG, Borba EF, Aikawa NE, et al. Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases. Ann Rheum Dis. 2011;70:1068-73."



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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult and juvenile systemic lupus erythematosus (SLE) and juvenile SLE patients according to the ACR classification criteria aged ≥ 18 years for adults and aged ≥ 9 and <18 years for the juvenile group
  • Patients with primary Sjögren's Syndrome (SSp) (classification criteria of the European Study Group on Diagnostic Criteria for Sjögren's Syndrome) aged ≥ 18 years

Exclusion Criteria:

  1. History of anaphylactic response to vaccine components or egg allergy
  2. Moderate or severe acute febrile illness
  3. Guillain-Barré syndrome, decompensated heart failure (class III or IV), demyelinating disease.
  4. History of live virus vaccine up to 4 weeks before, virus vaccine inactivated up to 2 weeks prior, influenza vaccine up to 6 months prior to study.
  5. History of having received blood products up to 6 months prior to the study.
  6. Individuals who do not agree to participate in the study and / or whose parents do not agree to participate in the study.
  7. Inpatients
  8. Patients with severe conditions requiring hospitalization

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): NCT03540823


Contacts
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Contact: Eduardo Borba, MD, PhD 55 11 30617490 eduardo.borba@hc.fm.usp.br
Contact: Nadia Aikawa, MD, PhD 55 11 30617490 nadia.aikawa@hc.fm.usp.br

Locations
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Brazil
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo Recruiting
São Paulo, Brazil, 05403-000
Contact: Eduardo Borba, MD, PhD    551130617490    eduardo.borba@hc.fm.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Eduardo Borba, MD, PhD Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo São Paulo, Sao Paulo Brazil

Publications of Results:
Other Publications:

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03540823     History of Changes
Other Study ID Numbers: H3N2VaccineReumatoHC
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Sjogren's Syndrome
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs