Skip to main content
Top
Published in: Immunologic Research 1-2/2015

01-02-2015 | CUTTING EDGE IN AUTOIMMUNITY

The epidemiological profile of ASIA syndrome after HPV vaccination: an evaluation based on the Vaccine Adverse Event Reporting Systems

Authors: Paolo Pellegrino, Valentina Perrone, Marco Pozzi, Carla Carnovale, Cristiana Perrotta, Emilio Clementi, Sonia Radice

Published in: Immunologic Research | Issue 1-2/2015

Login to get access

Abstract

The term “ASIA—Autoimmune/inflammatory Syndrome Induced by Adjuvants” describes an umbrella of clinical conditions sharing similar signs or symptoms, including post-vaccination phenomena. No information is available on the epidemiology of the ASIA syndrome, especially following HPV vaccination. We carried out an analysis of the VAERS database to retrieve all cases of suspected ASIA syndrome according to the Shoenfeld and Agmon-Levin’s guideline for the diagnosis. After causality assessment and case validation, 2,207 cases were considered probably or possibly related to vaccination. These represent the largest ASIA cohort ever reported and allowed us to estimate epidemiological and clinical characteristic of this syndrome. The commonest clinical manifestation observed were pyrexia (58 %), myalgia (27 %) and arthralgia or arthritis (19 %), and the estimated reporting rate was of 3.6 cases per 100,000 doses of HPV vaccine distributed (95 % CI 3.4–3.7). This study presents the first systematic estimation of ASIA incidence and expands the knowledge on this pathology. Further analyses are needed to identify genetic and non-genetic risk factors for ASIA syndrome.
Literature
3.
go back to reference Carvalho JF, Barros SM. ASIA or Shoenfeld’s syndrome: a novel autoimmune syndrome? Rev Bras Reumatol. 2010;50(5):487–8.PubMedCrossRef Carvalho JF, Barros SM. ASIA or Shoenfeld’s syndrome: a novel autoimmune syndrome? Rev Bras Reumatol. 2010;50(5):487–8.PubMedCrossRef
4.
go back to reference Carvalho JF, Barros SM, Branco JC, Fonseca JE. Asia or Shoenfeld’s syndrome: highlighting different perspectives for diffuse chronic pain. Acta Reumatol Port. 2011;36(1):10–2.PubMed Carvalho JF, Barros SM, Branco JC, Fonseca JE. Asia or Shoenfeld’s syndrome: highlighting different perspectives for diffuse chronic pain. Acta Reumatol Port. 2011;36(1):10–2.PubMed
6.
go back to reference Perricone C, Shoenfeld Y. Hepatitis B vaccination and undifferentiated connective tissue disease: another brick in the wall of the autoimmune/inflammatory syndrome induced by adjuvants (Asia). J Clin Rheumatol. 2013;19(5):231–3. doi:10.1097/RHU.0b013e31829d56f1.PubMedCrossRef Perricone C, Shoenfeld Y. Hepatitis B vaccination and undifferentiated connective tissue disease: another brick in the wall of the autoimmune/inflammatory syndrome induced by adjuvants (Asia). J Clin Rheumatol. 2013;19(5):231–3. doi:10.​1097/​RHU.​0b013e31829d56f1​.PubMedCrossRef
7.
go back to reference Toubi E. ASIA-autoimmune syndromes induced by adjuvants: rare, but worth considering. Isr Med Assoc J. 2012;14(2):121–4.PubMed Toubi E. ASIA-autoimmune syndromes induced by adjuvants: rare, but worth considering. Isr Med Assoc J. 2012;14(2):121–4.PubMed
8.
go back to reference Zafrir Y, Agmon-Levin N, Paz Z, Shilton T, Shoenfeld Y. Autoimmunity following hepatitis B vaccine as part of the spectrum of ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants’ (ASIA): analysis of 93 cases. Lupus. 2012;21(2):146–52. doi:10.1177/0961203311429318.PubMedCrossRef Zafrir Y, Agmon-Levin N, Paz Z, Shilton T, Shoenfeld Y. Autoimmunity following hepatitis B vaccine as part of the spectrum of ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants’ (ASIA): analysis of 93 cases. Lupus. 2012;21(2):146–52. doi:10.​1177/​0961203311429318​.PubMedCrossRef
9.
go back to reference Pellegrino P, Carnovale C, Perrone V, Antoniazzi S, Pozzi M, Clementi E, et al. No evidence of a link between multiple sclerosis and the vaccine against the human papillomavirus. Eur J Epidemiol. 2013;28(8):705–7. doi:10.1007/s10654-013-9830-y.PubMedCrossRef Pellegrino P, Carnovale C, Perrone V, Antoniazzi S, Pozzi M, Clementi E, et al. No evidence of a link between multiple sclerosis and the vaccine against the human papillomavirus. Eur J Epidemiol. 2013;28(8):705–7. doi:10.​1007/​s10654-013-9830-y.PubMedCrossRef
14.
go back to reference Pellegrino P, Carnovale C, Perrone V, Salvati D, Gentili M, Brusadelli T, et al. On the association between human papillomavirus vaccine and primary ovarian failure. Am J Reprod Immunol. 2014;71(4):293–4. doi:10.1111/aji.12190.PubMedCrossRef Pellegrino P, Carnovale C, Perrone V, Salvati D, Gentili M, Brusadelli T, et al. On the association between human papillomavirus vaccine and primary ovarian failure. Am J Reprod Immunol. 2014;71(4):293–4. doi:10.​1111/​aji.​12190.PubMedCrossRef
17.
go back to reference Szarewski A, Skinner SR, Garland SM, Romanowski B, Schwarz TF, Apter D, et al. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation. J Infect Dis. 2013;208(9):1391–6. doi:10.1093/infdis/jit360.PubMedCentralPubMedCrossRef Szarewski A, Skinner SR, Garland SM, Romanowski B, Schwarz TF, Apter D, et al. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation. J Infect Dis. 2013;208(9):1391–6. doi:10.​1093/​infdis/​jit360.PubMedCentralPubMedCrossRef
19.
go back to reference Wheeler CM, Castellsague X, Garland SM, Szarewski A, Paavonen J, Naud P, et al. Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol. 2012;13(1):100–10. doi:10.1016/S1470-2045(11)70287-X.PubMedCrossRef Wheeler CM, Castellsague X, Garland SM, Szarewski A, Paavonen J, Naud P, et al. Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol. 2012;13(1):100–10. doi:10.​1016/​S1470-2045(11)70287-X.PubMedCrossRef
22.
go back to reference Cruz-Tapias P, Agmon-Levin N, Israeli E, Anaya JM, Shoenfeld Y. Autoimmune (auto-inflammatory) syndrome induced by adjuvants (ASIA): animal models as a proof of concept. Curr Med Chem. 2013;20(32):4030–6.PubMedCrossRef Cruz-Tapias P, Agmon-Levin N, Israeli E, Anaya JM, Shoenfeld Y. Autoimmune (auto-inflammatory) syndrome induced by adjuvants (ASIA): animal models as a proof of concept. Curr Med Chem. 2013;20(32):4030–6.PubMedCrossRef
23.
go back to reference Perricone C, Colafrancesco S, Mazor RD, Soriano A, Agmon-Levin N, Shoenfeld Y. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) 2013: unveiling the pathogenic, clinical and diagnostic aspects. J Autoimmun. 2013;47:1–16. doi:10.1016/j.jaut.2013.10.004.PubMedCrossRef Perricone C, Colafrancesco S, Mazor RD, Soriano A, Agmon-Levin N, Shoenfeld Y. Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) 2013: unveiling the pathogenic, clinical and diagnostic aspects. J Autoimmun. 2013;47:1–16. doi:10.​1016/​j.​jaut.​2013.​10.​004.PubMedCrossRef
24.
go back to reference Soriano A, Butnaru D, Shoenfeld Y. Long-term inflammatory conditions following silicone exposure: the expanding spectrum of the autoimmune/inflammatory syndrome induced by adjuvants (ASIA). Clin Exp Rheumatol. 2014;32(2):151–4.PubMed Soriano A, Butnaru D, Shoenfeld Y. Long-term inflammatory conditions following silicone exposure: the expanding spectrum of the autoimmune/inflammatory syndrome induced by adjuvants (ASIA). Clin Exp Rheumatol. 2014;32(2):151–4.PubMed
31.
go back to reference Pellegrino P, Falvella FS, Perrone V, Carnovale C, Brusadelli T, Pozzi M, et al. The first steps towards the era of personalised vaccinology: predicting adverse reactions. Pharmacogenomics J. 2014;. doi:10.1038/tpj.2014.57.PubMed Pellegrino P, Falvella FS, Perrone V, Carnovale C, Brusadelli T, Pozzi M, et al. The first steps towards the era of personalised vaccinology: predicting adverse reactions. Pharmacogenomics J. 2014;. doi:10.​1038/​tpj.​2014.​57.PubMed
34.
go back to reference Pellegrino P, Carnovale C, Borsadoli C, Danini T, Speziali A, Perrone V, et al. Two cases of hallucination in elderly patients due to a probable interaction between flu immunization and tramadol. Eur J Clin Pharmacol. 2013;69(8):1615–6. doi:10.1007/s00228-013-1517-5.PubMedCrossRef Pellegrino P, Carnovale C, Borsadoli C, Danini T, Speziali A, Perrone V, et al. Two cases of hallucination in elderly patients due to a probable interaction between flu immunization and tramadol. Eur J Clin Pharmacol. 2013;69(8):1615–6. doi:10.​1007/​s00228-013-1517-5.PubMedCrossRef
37.
go back to reference Mitchell LA, Tingle AJ, MacWilliam L, Horne C, Keown P, Gaur LK, et al. HLA-DR class II associations with rubella vaccine-induced joint manifestations. J Infect Dis. 1998;177(1):5–12.PubMedCrossRef Mitchell LA, Tingle AJ, MacWilliam L, Horne C, Keown P, Gaur LK, et al. HLA-DR class II associations with rubella vaccine-induced joint manifestations. J Infect Dis. 1998;177(1):5–12.PubMedCrossRef
38.
go back to reference Pellegrino P, Carnovale C, Perrone V, Salvati D, Gentili M, Brusadelli T, et al. Epidemiological analysis on two decades of hospitalisations for meningitis in the United States. Eur J Clin Microbiol Infect Dis. 2014;33(9):1519–24. doi:10.1007/s10096-014-2102-2.PubMedCrossRef Pellegrino P, Carnovale C, Perrone V, Salvati D, Gentili M, Brusadelli T, et al. Epidemiological analysis on two decades of hospitalisations for meningitis in the United States. Eur J Clin Microbiol Infect Dis. 2014;33(9):1519–24. doi:10.​1007/​s10096-014-2102-2.PubMedCrossRef
41.
Metadata
Title
The epidemiological profile of ASIA syndrome after HPV vaccination: an evaluation based on the Vaccine Adverse Event Reporting Systems
Authors
Paolo Pellegrino
Valentina Perrone
Marco Pozzi
Carla Carnovale
Cristiana Perrotta
Emilio Clementi
Sonia Radice
Publication date
01-02-2015
Publisher
Springer US
Published in
Immunologic Research / Issue 1-2/2015
Print ISSN: 0257-277X
Electronic ISSN: 1559-0755
DOI
https://doi.org/10.1007/s12026-014-8567-3

Other articles of this Issue 1-2/2015

Immunologic Research 1-2/2015 Go to the issue

DIAGNOSTICS AND ENVIRONMENTAL FACTORS

Lupus and leprosy: beyond the coincidence