Risk of new onset autoimmune disease in 9- to 25-year-old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom

Willame, C; Rosillon, Dominique; Zima, Julia; Angelo, Maria-Genalin; Stuurman, Anke L.; Vroling, Hilde; Boggon, Rachael; Bunge, Eveline M.; Pladevall-Vila, Manel; Baril, Laurence

doi:10.1080/21645515.2016.1199308

Cited by 41 publications

(42 citation statements)

References 21 publications

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“…A cohort study was performed to assess the risk of new onset autoimmune disease in young women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom (55). The study reported an incidence rate ratio (95% CI) of 3.75 (1.25–11.31) for autoimmune thyroiditis among females.…”

Section: Autoimmune Thyroid Disease and Asia Syndromementioning

confidence: 99%

Autoimmune/Inflammatory Syndrome Induced by Adjuvants and Thyroid Autoimmunity

et al. 2017

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The autoimmune/inflammatory syndrome induced by adjuvants (ASIA), presented by Shoenfeld and Agmon-Levin in 2011, is an entity that incorporates diverse autoimmune conditions induced by the exposure to various adjuvants. Adjuvants are agents that entail the capability to induce immune reactions. Adjuvants are found in many vaccines and used mainly to increase the response to vaccination in the general population. Silicone has also been reported to be able to induce diverse immune reactions. Clinical cases and series of heterogeneous autoimmune conditions including systemic sclerosis, systemic lupus erythematosus, and rheumatoid arthritis have been reported to be induced by several adjuvants. However, only a small number of cases of autoimmune thyroid disorder have been included under the umbrella of ASIA syndrome. Indeed, clinical cases of Hashimoto’s thyroiditis and/or subacute thyroiditis were observed after the exposure to vaccines as well as silicone implantation. In our review, we aimed to summarize the current knowledge on ASIA syndrome presented as endocrinopathies, focusing on autoimmune thyroid disorders associated with the various adjuvants.

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Section: Autoimmune Thyroid Disease and Asia Syndromementioning

confidence: 99%

Autoimmune/Inflammatory Syndrome Induced by Adjuvants and Thyroid Autoimmunity

et al. 2017

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“…In the study by Willame et al 9-25 year-old women after the first AS04-HPV-16/18 vaccine dose were compared to three unexposed cohorts and were observed within the one year follow-up period [ 20 ]. In the study by Angelo et al three groups were considered: adolescent girls/women receiving HPV-16/18-vaccine alone (HPV group), subjects receiving HPV-16/18-vaccine coadministered with another vaccine and subjects receiving no vaccine (HVP group control) and unsolicited AEFI were reported for 30 days after each dose [ 19 ].…”

Section: Resultsmentioning

confidence: 99%

“…The most frequently reported events within one year of administration were: psoriasis, Grave’s disease, autoimmune thyroiditis and vasculitis, rheumatoid arthropathies and neuritis. The OR for each event showed no increased risk for women vaccinated with HPV vaccine [ 19 ].…”

Section: Resultsmentioning

confidence: 99%

HPV vaccine and autoimmune diseases: systematic review and meta-analysis of the literature

Genovese

Fauci

Squeri

et al. 2018

Journal of Preventive Medicine and Hygiene

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“…21 These findings are consistent with data provided by several studies, including a recent 3-year follow-up register-based cohort study in Finland and an observational 1-year follow-up cohort study in the UK where no evidence of an increased risk of NOADs following AS04-HPV-16/18 vaccination was observed in girls aged 11-15 y or in women aged 9-25 y, respectively. 22,23 The strengths and limitations of the study were described in detail in the previous paper which disclosed interim data. 7 One more possible limitation may link to the codes and classification of diagnoses in the registry.…”

Section: Discussionmentioning

confidence: 99%

Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: end-of-study results from a community-randomized study up to 6.5 years

Apter

Eriksson

et al. 2019

Human Vaccines & Immunotherapeutics

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This manuscript discloses end-of-study safety data of a community-randomized controlled trial in Finland (NCT00534638), assessing the effectiveness of two vaccination strategies (gender-neutral versus females only) using the AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18) vaccine. The total vaccination cohort included 32,175 adolescents aged 12-15 y at vaccination of whom 14,837 received the AS04-HPV-16/18 vaccine and 17,338 received the hepatitis-B virus vaccine (control). Spontaneous reporting of serious adverse events (SAEs) combined with surveillance using nation-wide health registries showed an acceptable safety profile of the AS04-HPV-16/18 vaccine. During the study period (up to 6.5 y), the incidences (per 100,000 person-years) of reported SAEs considered as possibly related to vaccination were 39.1 (95% confidence interval [CI]: 25.3-57.7) and 39.8 (95%CI: 26.8-56.8) in the HPV and control groups, respectively. The most frequently reported new-onset autoimmune diseases (NOADs) were ulcerative colitis (incidence rates of 28.2 and 33.1 per 100,000 person-years in the HPV and control groups, respectively), insulin-dependent diabetes mellitus (21.9 and 37.1), Crohn's disease (15.6 and 22.5), celiac disease (15.6 and 21.2), and juvenile idiopathic arthritis (14.1 and 15.9). Of 1,344 pregnancies reported (777 and 567 in the HPV and control groups, respectively), most resulted in elective termination (58.4% and 58.6%), birth of a live infant (32.7% and 32.3%), or in spontaneous abortion (8.0% and 7.9%). No major, registered congenital anomalies were identified. The incidence rates of NOADs and pregnancy outcomes were generally balanced between groups. No specific safety signals were identified in the populationbased health registry surveillance. Plain Language SummaryWhat is the context?• Since first licensure in 2007 of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine (Cervarix, GSK), large quantity of safety data has been collected and confirmed its safety profile. This study provides further unique, population-based safety data from vaccinated Finnish adolescents monitored via health registries up to 6.5 y of follow-up.What is new?• The vaccine has shown an acceptable safety profile in girls and boys. The risk of new-onset autoimmune diseases (NOADs) was similar between the HPV vaccine group and the control group and in line with the expectations for the studied population. • The study supports that safety surveillance via national health registries is in general more sensitive than the conventional safety reporting, notably for monitoring specific chronic diseases, e.g. autoimmune disorders.

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Risk of new onset autoimmune disease in 9- to 25-year-old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom

Cited by 41 publications

References 21 publications

Autoimmune/Inflammatory Syndrome Induced by Adjuvants and Thyroid Autoimmunity

Autoimmune/Inflammatory Syndrome Induced by Adjuvants and Thyroid Autoimmunity

HPV vaccine and autoimmune diseases: systematic review and meta-analysis of the literature

Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: end-of-study results from a community-randomized study up to 6.5 years

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