Incidence of new‐onset autoimmune disease in girls and women with pre‐existing autoimmune disease after quadrivalent human papillomavirus vaccination: a cohort study

Grönlund, O.; Herweijer, Eva; Sundström, Karin; Arnheim-Dahlström, Lisen

doi:10.1111/joim.12535

Cited by 38 publications

(27 citation statements)

References 26 publications

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“…The combined analysis of mild AEFV (similar to the HC group) and stable disease activity throughout the study showed that the 3-dose scheme of qHPV vaccine was safe in this JDM cohort. Our results are in accordance with other studies that showed no in uence of HPV vaccines regarding AEFV and disease activity in patients with AID (8,29,30,(42)(43)(44)(45).…”

Section: Discussionsupporting

confidence: 93%

Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in Patients with Juvenile Dermatomyositis: A Real-World Multicentre Study

Grein¹,

Pinto

Groot

et al. 2020

Preprint

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Background: Concerns about the safety and efficacy of vaccines in patients with autoimmune diseases (AID) have led to contradictions and low vaccination coverage in this population, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccines have been recommended for immunocompromised patients, there is still a lack of data to support its use for AID patients, such as juvenile dermatomyositis (JDM) patients. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in a cohort of JDM patients.Methods: JDM patients aged from 9-20 years and healthy controls (HC) were enrolled to receive a 3-dose schedule of qHPV vaccine from March/2014 to March/2016. Study visits were performed before the first dose, one month after the second and third doses, and six months after the third dose. Participants completed a diary of possible adverse events for 14 days following each dose of vaccination (AEFV). Disease activity and current therapy were analyzed at each visit for JDM patients. In addition, serum samples from all participants were collected to test antibody concentrations against HPV16 and 18 at each visit. Participant recruitment was conducted in ten Brazilian centres. From 47 eligible JDM patients and 41 HC, 42 and 35, respectively, completed the 3-dose schedule of the vaccine, given that five JDM patients and two HC had received doses prior to their inclusion in the study.Results: The AEFVs presented by the participants were mild and in general did not differ between JDM and HC groups. No severe AEFVs were related to the vaccination. Disease activity was stable, or even improved during the follow-up. One month after the third dose of the vaccine the JDM group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the HC group, who presented 100% for both serotypes (p = 1.000). Six months after the third dose the seropositivity for the patient group was 94% for both HPV types.Conclusions: The HPV vaccination in this cohort of JDM patients was safe and immunogenic. Since the seropositivity against HPV16 and 18 was very high after the 3-dose schedule, this regimen should be recommended for JDM patients.Trial registration: Brazilian Clinical Trials Registry, number: RBR-9ypbtf, link: http://www.ensaiosclinicos.gov.br/rg/RBR-9ypbtf/. Registered 20 March 2018 – Retrospectively registered.

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Section: Discussionsupporting

confidence: 93%

Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in Patients with Juvenile Dermatomyositis: A Real-World Multicentre Study

Grein¹,

Pinto

Groot

et al. 2020

Preprint

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“…Notably, concerns regarding the safety of HPV vaccine have been raised based by case reports and case series on the onset of autoimmune diseases following HPV vaccination 180–185. Population based studies have consistently shown that quadrivalent HPV vaccine was not associated with increased incidence of new-onset autoimmune disease in girls and women with pre-existing autoimmune disease 186–188. Therefore, based on the present data, the task force agreed that HPV vaccination should be encouraged for patients with AIIRD, with a particular focus on patients with SLE, as indicated for the general population.…”

Section: Resultsmentioning

confidence: 74%

2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases

et al. 2019

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To update the European League Against Rheumatism (EULAR) recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) published in 2011. Four systematic literature reviews were performed regarding the incidence/prevalence of vaccine-preventable infections among patients with AIIRD; efficacy, immunogenicity and safety of vaccines; effect of anti-rheumatic drugs on the response to vaccines; effect of vaccination of household of AIIRDs patients. Subsequently, recommendations were formulated based on the evidence and expert opinion. The updated recommendations comprise six overarching principles and nine recommendations. The former address the need for an annual vaccination status assessment, shared decision-making and timing of vaccination, favouring vaccination during quiescent disease, preferably prior to the initiation of immunosuppression. Non-live vaccines can be safely provided to AIIRD patients regardless of underlying therapy, whereas live-attenuated vaccines may be considered with caution. Influenza and pneumococcal vaccination should be strongly considered for the majority of patients with AIIRD. Tetanus toxoid and human papilloma virus vaccination should be provided to AIIRD patients as recommended for the general population. Hepatitis A, hepatitis B and herpes zoster vaccination should be administered to AIIRD patients at risk. Immunocompetent household members of patients with AIIRD should receive vaccines according to national guidelines, except for the oral poliomyelitis vaccine. Live-attenuated vaccines should be avoided during the first 6 months of life in newborns of mothers treated with biologics during the second half of pregnancy. These 2019 EULAR recommendations provide an up-to-date guidance on the management of vaccinations in patients with AIIRD.

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“…While considered effective in preventing infection, [78][79][80] the vaccines raised fervent debates across the scientific community with regards to their safety profile, and specifically their suspected association with the development of autoimmune phenomena. 81,82 Whereas some studies present no association between HPV vaccines and autoimmune adverse events, [83][84][85][86] others have addressed the significant limitations of many of these analyses. 87,88 The answer remains largely disputed, yet the attention drawn to HPV may be responsible for some intriguing discoveries regarding potential molecular mimicry between HPV and human proteins.…”

Section: Human Papilloma Virus Vaccines: a Veil Of Concern Remains Unmentioning

confidence: 99%

Vaccine-induced autoimmunity: the role of molecular mimicry and immune crossreaction

2018

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Since the early 1800s vaccines have saved numerous lives by preventing lethal infections. However, during the past two decades, there has been growing awareness of possible adverse events associated with vaccinations, cultivating heated debates and leading to significant fluctuations in vaccination rates. It is therefore pertinent for the scientific community to seriously address public concern of adverse effects of vaccines to regain public trust in these important medical interventions. Such adverse reactions to vaccines may be viewed as a result of the interaction between susceptibility of the vaccinated subject and various vaccine components. Among the implicated mechanisms for these reactions is molecular mimicry. Molecular mimicry refers to a significant similarity between certain pathogenic elements contained in the vaccine and specific human proteins. This similarity may lead to immune crossreactivity, wherein the reaction of the immune system towards the pathogenic antigens may harm the similar human proteins, essentially causing autoimmune disease. In this review, we address the concept of molecular mimicry and its application in explaining post vaccination autoimmune phenomena. We further review the principal examples of the influenza, hepatitis B, and human papilloma virus vaccines, all suspected to induce autoimmunity via molecular mimicry. Finally, we refer to possible implications on the potential future development of better, safer vaccines.

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Incidence of new‐onset autoimmune disease in girls and women with pre‐existing autoimmune disease after quadrivalent human papillomavirus vaccination: a cohort study

Abstract: In this nationwide study, qHPV vaccination was not associated with increased incidence of new-onset autoimmune disease in girls and women with pre-existing autoimmune disease.

Cited by 38 publications

References 26 publications

Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in Patients with Juvenile Dermatomyositis: A Real-World Multicentre Study

Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in Patients with Juvenile Dermatomyositis: A Real-World Multicentre Study

2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases

Vaccine-induced autoimmunity: the role of molecular mimicry and immune crossreaction

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