Pandemic influenza immunization in primary antiphospholipid syndrome (PAPS): a trigger to thrombosis and autoantibody production?

Medeiros, Dina; Silva, C A; Bueno, Carolina Tosin; Medeiros-Ribeiro, Ana Cristina; Viana, Vilma dos Santos Trindade; Carvalho, Jozélio Freire de; Bonfá, Eloísa

doi:10.1177/0961203314540351

Cited by 10 publications

(7 citation statements)

References 14 publications

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“…Supporting this notion, aPL titers were comparable before and after complete vaccination, an encouraging nding since aPL has an important role in the PAPS thrombogenesis 10 . Consistent with this observation, we have not detected a signi cant production of aPL-related antibodies nor thrombotic events after the pandemic in uenza immunization in PAPS patients 43 . Furthermore, a larger Chinese study with 406 healthy-workers immunized with inactivated SARS-CoV-2 vaccine (BBIBPCorV, Sinopharm, Beijing, China) found no signi cant difference in aPL measurement in serial blood samples before and 4 weeks after the second dose 44 .…”

Section: Discussionsupporting

confidence: 89%

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Immunogenicity, Safety and Antiphospholipid Antibodies After SARS-CoV-2 Vaccine in Patients With Primary Antiphospholipid Syndrome

Signorelli

Balbi

Aikawa

et al. 2021

Preprint

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Background: Coronavirus disease 19 (COVID-19) has an increased risk of coagulopathy with high frequency of antiphospholipid antibodies (aPL). The recent reports of thrombosis associated with the adenovirus-based vaccines raises concern that SARS-CoV-2 immunization in primary antiphospholipid syndrome (PAPS) patients may trigger a dysregulated immune response with possible clotting complications. Therefore, the objectives of this study were to assess immunogenicity, aPL production and safety of Sinovac-Coronavac in PAPS patients.Methods: This prospective controlled phase 4 study of SARS-CoV-2-naïve PAPS patients and a control group (CG) consisted of a two-dose Sinovac-CoronaVac (D0/D28) and blood collection before vaccination (D0), at D28 and 6 weeks after second dose (D69) for immunogenicity/aPL levels. Outcomes were seroconversion (SC) rates of anti-SARS-CoV-2 S1/S2 IgG and/or neutralizing antibodies (NAb) at D28/D69. Safety and aPL production were also assessed. Results: Forty-four PAPS patients and 132 CG had comparable age (p=0.982) and sex (p>0.999). At D69, both groups had high and comparable SC (83.9% vs. 93.5%, p=0.092) and GMT [50.2(95%CI 34.5-73.2) vs. 61.7 (95%CI 52.8-72.3), p=0.249] as well as NAb positivity (77.4% vs. 78.7%, p=0.440), and NAb-activity [64.3% (49.0-77.0) vs. 60.9% (45.6-81.3), p=0.689]. Of note, for D28, the antibody response was very low and also similar in both groups SC (25.8% vs. 30.6% p=0.609). Antiphospholipid levels remained stable throughout the study at D0 vs D28 vs D69 (IgG aCL, p=0.058; IgM aCL, p=0.091; IgG aβ2GPI, p=0.513 and IgM aβ2GPI, p=0.468). Thrombotic event up to 6 months or other moderate/severe side effects were not observed.Conclusions: We provide novel evidence that Sinovac-CoronaVac vaccine has a high immunogenicity and excellent safety profile in PAPS. We further demonstrated that this vaccine did not trigger thrombosis or induced changes in aPL-related antibodies production. Our findings strongly support the recommendation of SARS-CoV-2 vaccination for PAPS patients.Trial registration: ClinicalTrials.gov - Identifier: NCT04754698 first registered on February 8th, 2021.

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Section: Discussionsupporting

confidence: 89%

“…The frequency of NAb at D28 was lower in naïve-PAPS patients than CG (16.1% vs. 35.2%, p = 0.043), with a robust rise at D69 and comparable NAb positivity rates among both groups (77.4% vs. 78.7%, p = 0.440). NAb-activity was comparable in naïve-PAPS patients and CG at D28 [38.1% (32.0-55.5) vs 43…”

mentioning

confidence: 99%

Immunogenicity, Safety and Antiphospholipid Antibodies After SARS-CoV-2 Vaccine in Patients With Primary Antiphospholipid Syndrome

Signorelli

Balbi

Aikawa

et al. 2021

Preprint

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“…Another study, which employed a large panel of autoantibodies for screening, investigated 45 primary APS patients and 33 healthy controls after A/H1N1 non-adjuvant vaccine administration. In contrary to the previous study, they failed to find short- or long-term sequelae involving a significant increase of aPL-related antibodies and thrombosis, suggesting that influenza vaccine, at least without adjuvant, is safe (98).…”

Section: Vaccinescontrasting

confidence: 71%

Environmental Triggers of Autoreactive Responses: Induction of Antiphospholipid Antibody Formation

2019

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Antiphospholipid antibodies (aPLs) comprise a diverse family of autoantibodies targeted against proteins with the affinity toward negatively charged phospholipids or protein-phospholipid complexes. Their clinical significance, including prothrombotic potential of anti-cardiolipin antibodies (aCLs), anti-β2-glycoprotein I antibodies (aβ2-GPIs), and lupus anti-coagulant (LA), is well-established. However, the ontogeny of these pathogenic aPLs remains less clear. While transient appearance of aPLs could be induced by various environmental factors, in genetically predisposed individuals these factors may eventually lead to the development of the antiphospholipid syndrome (APS). Since the first description of APS, it has been found that a wide variety of microbial and viral agents influence aPLs production and contribute to clinical manifestations of APS. Many theories attempted to explain the pathogenic potential of different environmental factors as well as a phenomenon termed molecular mimicry between β2-GPI molecule and infection-relevant structures. In this review, we summarize and critically assess the pathogenic and non-pathogenic formation of aPLs and its contribution to the development of APS.

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“…APLAs are acquired autoantibodies against phospholipid–protein complexes, which act as important autoantibodies in anti-phospholipid syndrome. Previous studies indicated that APLA is associated with pregnancy [ 9 ], thrombosis [ 10 ] and stroke [ 11 ]. Several studies also reported a potential association between the APLA and risk of RVO [ 12 – 22 ], but no accordant conclusion was obtained.…”

Section: Introductionmentioning

confidence: 99%

Antiphospholipid Antibody and Risk of Retinal Vein Occlusion: A Systematic Review and Meta-Analysis

Zhu

et al. 2015

PLoS ONE

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BackgroundRetinal vein occlusion (RVO) is a common retinal vascular disease and it is one of the most frequently reported causes of visual damage and blindness in the elderly. The current study investigated the potential association between antiphospholipid antibodies (APLA) and RVO risk by conducting a meta-analysis of case–control studies.MethodsA systematic literature search of Pubmed and Embase databases was conducted in August 1st, 2014. Odds ratios (ORs) were used to evaluate the associations between APLA and the incidence of RVO. A random-effects model was obtained for the quantitative synthesis.ResultsA total of 11 studies were included in this meta-analysis. A meta-analysis of all studies assessing the risk of RVO revealed that APLA was associated with a statistically increased risk of RVO incidence (OR = 5.18, 95% CI = [3.37, 7.95]). The association between anticardiolipin antibodies (ACA) and the risk of RVO was significant (n =8, OR = 4.59, 95% CI = [2.75, 7.66]). However, the association between lupus anticoagulants (LA) and risk of RVO was non-significant (n = 5, OR = 3.90, 95% CI = [0.99, 15.37]). No significant publication bias was found in the 11 selected studies.ConclusionAPLA was significantly associated with the risk of RVO. Advanced analyses showed that ACA rather than LA affected the risk of RVO. Additional well-designed and well-conducted epidemiological studies are required to further our understanding of the relationship between APLA and RVO risk.

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Pandemic influenza immunization in primary antiphospholipid syndrome (PAPS): a trigger to thrombosis and autoantibody production?

Abstract: This is the first study to demonstrate that pandemic influenza vaccine in PAPS patients does not trigger short- and long-term thrombosis or a significant production of aPL-related antibodies (ClinicalTrials.gov, #NCT01151644).

Cited by 10 publications

References 14 publications

Immunogenicity, Safety and Antiphospholipid Antibodies After SARS-CoV-2 Vaccine in Patients With Primary Antiphospholipid Syndrome

Immunogenicity, Safety and Antiphospholipid Antibodies After SARS-CoV-2 Vaccine in Patients With Primary Antiphospholipid Syndrome

Environmental Triggers of Autoreactive Responses: Induction of Antiphospholipid Antibody Formation

Antiphospholipid Antibody and Risk of Retinal Vein Occlusion: A Systematic Review and Meta-Analysis

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