Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases
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| ClinicalTrials.gov Identifier: NCT01151644 |
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Recruitment Status : Unknown
Verified April 2010 by University of Sao Paulo.
Recruitment status was: Active, not recruiting
First Posted : June 28, 2010
Last Update Posted : June 28, 2010
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Sponsor:
University of Sao Paulo
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
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Brief Summary:
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 or disease | Intervention/treatment | 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 (Clinical Trial) |
| Estimated Enrollment : | 5000 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases |
| Study Start Date : | April 2010 |
| Estimated Primary Completion Date : | July 2010 |
| Estimated Study Completion Date : | December 2010 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Influenza Vaccines
| Arm | Intervention/treatment |
|---|---|
| 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) |
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 ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| 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
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): 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
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 |
| Other Study ID Numbers: |
CEDMAC-H1N1 |
| First Posted: | June 28, 2010 Key Record Dates |
| Last Update Posted: | June 28, 2010 |
| Last Verified: | April 2010 |
Keywords provided by University of Sao Paulo:
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H1N1 VACCINE INFLUENZA RHEUMATIC DISEASES ANTI-H1N1 IMMUNIZATION |
Additional relevant MeSH terms:
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Arthritis Rheumatic Diseases Sjogren's Syndrome Arthritis, Juvenile Dermatomyositis Vasculitis Systemic Vasculitis Lupus Erythematosus, Systemic Scleroderma, Systemic Collagen Diseases Connective Tissue Diseases Antiphospholipid Syndrome Syndrome Disease Pathologic Processes |
Joint Diseases Musculoskeletal Diseases Arthritis, Rheumatoid Autoimmune Diseases Immune System Diseases Skin Diseases Xerostomia Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Dry Eye Syndromes Lacrimal Apparatus Diseases Eye Diseases Vascular Diseases Cardiovascular Diseases |