Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01151644
First received: June 25, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

The prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patients. One of the ways to prevent such complications is vaccination. In 2009, a new pandemic strain of influenza virus (A/H1N1/2009) has emerged raising major concerns for public health. Patients under immunosuppressive therapy have indication for immunization against influenza virus H1N1. There are, however, concerns about possibility of reactivation of autoimmune diseases, determine adverse events and insufficient immunogenicity in these patients. The lack of studies evaluating the efficacy and safety of the vaccine against influenza A(H1N1)/2009 in these rheumatic patients led to the development of this research. The objectives of this study are to evaluate the humoral response and safety of the vaccine virus A(H1N1)/2009 in immunosuppressed patients with rheumatic diseases compared to healthy controls. We have recruited 400 patients with rheumatoid arthritis, 350 with spondyloarthritis, 1000 with systemic lupus erythematosus (SLE), 150 with dermatomyositis (DM), 100 with mixed connective tissue disease, 150 with systemic vasculitis, 250 with systemic sclerosis (SSc) , 100 with Sjögren's syndrome, 100 with antiphospholipid syndrome, 100 patients with juvenile idiopathic arthritis, 80 with juvenile SLE, and 80 with juvenile DM, followed at our Rheumatology Outpatient Division and Unit Pediatric Rheumatology Children's Institute, HC-FMUSP. The control group was recruited were 200 healthy employees of ICHC-FMUSP. Informed consent was obtained from all participants and the study was approved by the Local Ethical Committee. All subjects were vaccinated against influenza virus A/(H1N1)/2009 (vaccine approved and supplied by Instituto Butantan-São Paulo). Blood samples was collected to measure levels of antibodies inhibiting hemagglutination by influenza virus A (H1N1)/2009 immediately prior to vaccination and 21 to 28 days after vaccination., Participants fulfilled a questionnaire on the immediate side effects of the vaccine. All patients with rheumatoid arthritis, spondyloarthritis, SLE, DM, systemic vasculitis, juvenile idiopathic arthritis, juvenile SLE, and DM were assessed before and 21 days after vaccination for clinical, laboratory parameters of disease activity as well as treatment. Continuous variables will be compared by t-test to evaluate differences between patients with rheumatic diseases versus healthy controls. Differences between categorical variables will be evaluated using the chi-square or Fisher exact test. Statistical significance was set at p<0.05.


Condition Intervention Phase
Rheumatoid Arthritis
Spondyloarthritis
Systemic Lupus Erythematosus (SLE)
Dermatomyositis (DM)
DMixed Connective Tissue Disease
Systemic Vasculitis
Systemic Sclerosis (SSc)
Sjögren's Syndrome
Antiphospholipid Syndrome
Juvenile Idiopathic Arthritis
Juvenile SLE
Juvenile DM
Biological: Anti-pandemic H1N1 influenza vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Safety (adverse effects) and efficacy (serconversion rate) after 21 days from the vaccination [ Time Frame: Before and after 21 days from vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: April 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VACCINATION OF PATIENTS Biological: Anti-pandemic H1N1 influenza vaccine
inactivated, NON-adjuvanted pandemic H1N1 influenza vaccine (A/California/7/2009)
Active Comparator: VACCINATION OF HEALTHY CONTROLS Biological: Anti-pandemic H1N1 influenza vaccine
inactivated, NON-adjuvanted pandemic H1N1 influenza vaccine (A/California/7/2009)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Rheumatic diseases according to international criteria of each disorder

Exclusion Criteria:

  • Previous and confirmed infection by virus A(H1N1)/2009
  • History of anaphylatic reaction to egg components
  • Acute fever
  • Guillain-Barré syndrome, heart failure (classes III or IV), demyelinating disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01151644

Locations
Brazil
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ELOISA BONFÁ, RHEUMATOLOGY DIVISION, HOSPITAL DAS CLINICAS DA FACULDADE DE MEDICIAN DA UNIVERSIDADE DE SÃO PAULO
ClinicalTrials.gov Identifier: NCT01151644     History of Changes
Other Study ID Numbers: CEDMAC-H1N1
Study First Received: June 25, 2010
Last Updated: June 25, 2010
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
H1N1 VACCINE
INFLUENZA
RHEUMATIC DISEASES
ANTI-H1N1 IMMUNIZATION

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Arthritis
Arthritis, Juvenile
Arthritis, Rheumatoid
Connective Tissue Diseases
Dermatomyositis
Lupus Erythematosus, Systemic
Rheumatic Diseases
Scleroderma, Diffuse
Scleroderma, Systemic
Sjogren's Syndrome
Spondylarthritis
Syndrome
Systemic Vasculitis
Vasculitis
Autoimmune Diseases
Bone Diseases
Cardiovascular Diseases
Disease
Dry Eye Syndromes
Eye Diseases
Immune System Diseases
Joint Diseases
Lacrimal Apparatus Diseases
Mouth Diseases
Muscular Diseases
Musculoskeletal Diseases
Myositis
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 20, 2014