Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases

Saad, Carla G. S.; Borba, Eduardo F.; Aikawa, Nádia E.; Silva, Clóvis A.; Pereira, Rosa Maria Rodrigues; Calich, Ana Luisa; Moraes, José Reinaldo da Silva Cabral de; Ribeiro, Ana C.; Viana, Vilma Santos Trindade; Pasoto, Sandra Gofinet; Carvalho, Jozélio Freire de; França, Ivan; Guedes, Lissiane Karine Noronha; Shinjo, Samuel Katsuyuki; Sampaio-Barros, Percival D.; Caleiro, Maria Teresa Correia; Gonçalves, Célio Roberto; Fuller, Ricardo; Levy‐Neto, Maurício; Timenetsky, María do Carmo Sampaio Tavares; Precioso, Alexander Roberto; Bonfá, Eloísa

doi:10.1136/ard.2011.150250

Cited by 93 publications

(86 citation statements)

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“…Patients with JDM had a deficient seroconversion rate, which is in accord with a report for the same vaccine in adult DM 21 . This finding may be associated with the underlying pathology of this disease, which is known to involve the humoral endotheliopathy initiated by complement deposition in intramuscular blood vessels 28 .…”

Section: Discussionsupporting

confidence: 73%

“…The lower immune response to vaccine that we observed in the primary vasculitis group contrasts with the adequate response in reports concerning adult patients with granulomatosis with polyangiitis immunized with seasonal 29 and pandemic H1N1 vaccine 21 . The most likely explanation for this discrepancy is the limited number of children with primary vasculitis analyzed in our study and the underrepresentation of granulomatosis with polyangiitis in our sample.…”

Section: Discussioncontrasting

confidence: 54%

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Glucocorticoid: Major Factor for Reduced Immunogenicity of 2009 Influenza A (H1N1) Vaccine in Patients with Juvenile Autoimmune Rheumatic Disease

Aikawa

Campos²,

Silva³

et al. 2011

J Rheumatol

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Objective.To assess the immunogenicity and safety of non-adjuvanted influenza A H1N1/2009 vaccine in patients with juvenile autoimmune rheumatic disease (ARD) and healthy controls, because data are limited to the adult rheumatologic population.Methods.A total of 237 patients with juvenile ARD [juvenile systemic lupus erythematosus (JSLE), juvenile idiopathic arthritis (JIA), juvenile dermatomyositis (JDM), juvenile scleroderma, and vasculitis] and 91 healthy controls were vaccinated. Serology for anti-H1N1 was performed by hemagglutination inhibition assay. Seroprotection rate, seroconversion rate, and factor-increase in geometric mean titer (GMT) were calculated. Adverse events were evaluated.Results.Age was comparable in patients and controls (14.8 ± 3.0 vs 14.6 ± 3.7 years, respectively; p = 0.47). Three weeks after immunization, seroprotection rate (81.4% vs 95.6%; p = 0.0007), seroconversion rate (74.3 vs 95.6%; p < 0.0001), and the factor-increase in GMT (12.9 vs 20.3; p = 0.012) were significantly lower in patients with juvenile ARD versus controls. Subgroup analysis revealed reduced seroconversion rates in JSLE (p < 0.0001), JIA (p = 0.008), JDM (p = 0.025), and vasculitis (p = 0.017). Seroprotection (p < 0.0001) and GMT (p < 0.0001) were decreased only in JSLE. Glucocorticoid use and lymphopenia were associated with lower seroconversion rates (60.4 vs 82.9%; p = 0.0001; and 55.6 vs 77.2%; p = 0.012). Multivariate logistic regression including diseases, lymphopenia, glucocorticoid, and immunosuppressants demonstrated that only glucocorticoid use (p = 0.012) remained significant.Conclusion.This is the largest study to demonstrate a reduced but adequate immune response to H1N1 vaccine in patients with juvenile ARD. It identified current glucocorticoid use as the major factor for decreased antibody production. The short-term safety results support its routine recommendation for patients with juvenile ARD. ClinicalTrials.gov; NCT01151644.

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Section: Discussionsupporting

confidence: 73%

Section: Discussioncontrasting

confidence: 54%

Glucocorticoid: Major Factor for Reduced Immunogenicity of 2009 Influenza A (H1N1) Vaccine in Patients with Juvenile Autoimmune Rheumatic Disease

Aikawa

Campos²,

Silva³

et al. 2011

J Rheumatol

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“…Among other immunocompromised populations, primarily cancer patients and transplant recipients (individuals receiving hematopoietic stem cell or solid organ transplants), single doses of both unadjuvanted and adjuvanted inactivated influenza vaccines have solicited only moderate immunological responses in adults [269,[273][274][275][276][277][278][279] and children. [280][281][282] Many of these studies found that a second dose significantly improved the proportion achieving serological protection.…”

Section: Disease Burdenmentioning

confidence: 99%

2012/13 influenza vaccine effectiveness against hospitalised influenza A(H1N1)pdm09, A(H3N2) and B: estimates from a European network of hospitals

Rondy¹,

Launay

Puig-Barberà

et al. 2015

Eurosurveillance

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“…Further studies should now address whether some vaccines may induce a relapse or worsen the course of the disease in patients previously diagnosed with ITP, as has already been investigated for rheumatoid arthritis and systemic lupus erythematosus. [34][35][36][37] …”

Section: Org Frommentioning

confidence: 99%

A case-control study to assess the risk of immune thrombocytopenia associated with vaccines

Grimaldi-Bensouda

Michel

Aubrun³

et al. 2012

Blood

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IntroductionImmune thrombocytopenia (ITP) is an autoimmune disease characterized by low platelet counts due to increased destruction and impaired platelet production, partially related to the presence of autoantibodies directed toward platelet-membrane antigens. 1 ITP manifestations include various degrees of cutaneous and/or mucosal purpura; life-threatening hemorrhages occur in less than 5% of adult patients. 2 Onset is frequently insidious and low platelet counts often last beyond 6 months. 3 In adults, the incidence of ITP is approximately 3.3 per 100 000 person-years. 4,5 Studies have suggested that immunizations could be involved in the development of autoimmune disorders. 6 This could be because of molecular mimicry, in which antigens of the host are recognized as being similar to antigens of the immunization, thus provoking the development of autoantibodies. 7,8 Although several populationbased studies have described an association between the measlesmumps-rubella vaccine and ITP in children, 9-12 published evidence concerning the risk associated with other vaccines or with vaccination in adults is sparse and limited to a few case reports. [13][14][15][16][17] The risk of ITP associated with adult vaccines therefore remains controversial. The objective of this prospective case-control study was to explore the incidence of ITP in relation to all vaccination in adults, with a special emphasis on vaccines against influenza (the injectable/killed type only) and diphtheria-tetanus-pertussispoliomyelitis (DTPP). Methods PatientsThis case-control study prospectively recruited consecutive patients with newly diagnosed ITP at 22 internal medicine and hematology centers in continental France and compared them with controls recruited from general practice settings. Cases and controls were recruited from the same geographically diverse areas. All participants (cases and controls) provided informed written consent to participate in the study, were 18-79 years of age, could read French, and were capable of answering questions by a The online version of this article contains a data supplement.The publication costs of this article were defrayed in part by page charge payment. Therefore, and solely to indicate this fact, this article is hereby marked ''advertisement'' in accordance with 18 USC section 1734. For personal use only. on May 11, 2018. by guest www.bloodjournal.org From qualified telephone interviewer. Cases and controls were excluded from the study if they had a history of thrombocytopenia.The study protocol was submitted to the ethical review committee of Paris-Ile de France III (Comité de Protection des Personnes Ile de France III) and was approved by the French Data Protection Authority (Commission Nationale de l'Informatique et des Libertés). All participants signed an informed consent form in accordance with the Declaration of Helsinki. Study populationCase subjects. We conducted this study using patient data retrieved from the Pharmacoepidemiological General Research on ITP (PGRx-ITP) registry, a French...

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Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases

Abstract: The novel recognition of a diverse vaccine immunogenicity profile in distinct ARDs supports the notion that a booster dose may be recommended for diseases with suboptimal immune responses. This large study also settles the issue of vaccine safety. (ClinicalTrials.gov #NCT01151644).

Cited by 93 publications

References 37 publications

Glucocorticoid: Major Factor for Reduced Immunogenicity of 2009 Influenza A (H1N1) Vaccine in Patients with Juvenile Autoimmune Rheumatic Disease

Glucocorticoid: Major Factor for Reduced Immunogenicity of 2009 Influenza A (H1N1) Vaccine in Patients with Juvenile Autoimmune Rheumatic Disease

2012/13 influenza vaccine effectiveness against hospitalised influenza A(H1N1)pdm09, A(H3N2) and B: estimates from a European network of hospitals

A case-control study to assess the risk of immune thrombocytopenia associated with vaccines

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