Skip to main content
Hauptrubriken
CME Facharzt-Training Webinare Zeitschriften Bücher e.Medpedia Podcast
Service
Jobbörse Info & Hilfe
Fachgebiete
Anästhesiologie Allgemeinmedizin Arbeitsmedizin Augenheilkunde Chirurgie Dermatologie Gynäkologie und Geburtshilfe HNO Innere Medizin Kardiologie Neurologie Onkologie und Hämatologie Orthopädie und Unfallchirurgie Pädiatrie Pathologie Psychiatrie Radiologie Rechtsmedizin Urologie Zahnmedizin
Themen
Klimawandel und Gesundheit Neues aus dem Markt COVID-19 Praxis und Beruf Seltene Erkrankungen GOÄ & EBM Panorama
Sammlungen
Kasuistiken Algorithmen & Infografiken Blickdiagnosen Arthropedia FlapFinder (für Dermatochirurgen) Videos Kongressberichterstattung Medizin für Apothekerinnen und Apotheker Für Ärztinnen und Ärzte in Weiterbildung Für Medizinstudierende
Erweiterte Suche
Anmelden
nach oben
Drug Safety
Erschienen in: Drug Safety 4/2018

01.04.2018 | Review Article

Safety of Human Papillomavirus Vaccines: An Updated Review

verfasst von: Anastasia Phillips, Cyra Patel, Alexis Pillsbury, Julia Brotherton, Kristine Macartney

Erschienen in: Drug Safety | Ausgabe 4/2018

Einloggen, um Zugang zu erhalten

Abstract

Human papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and quadrivalent (4vHPV) vaccines. A nonavalent (9vHPV) vaccine is now available and HPV immunisation programmes have been extended to males in 11 countries. The aim of this updated narrative review was to examine the evidence on HPV vaccine safety, focusing on the 9vHPV vaccine, special populations and adverse events of special interest (AESI). The previous searches were replicated to identify studies to August 2016, including additional search terms for AESI. We identified 109 studies, including 15 population-based studies in over 2.5 million vaccinated individuals across six countries. All vaccines demonstrated an acceptable safety profile; injection-site reactions were slightly more common for 9vHPV vaccine than for 4vHPV vaccine. There was no consistent evidence of an increased risk of any AESI, including demyelinating syndromes or neurological conditions such as complex regional pain or postural orthostatic tachycardia syndromes. The risk–benefit profile for HPV vaccines remains highly favourable.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
1.
Koutsky L. Epidemiology of genital human papillomavirus infection. Am J Med. 1997;102(5a):3–8.CrossRefPubMed
2.
Garland S, Brotherton J, Condon J, McIntyre P, Stevens MP, Smith D, et al. Human papillomavirus prevalence among indigenous and non indigenous Australian women prior to a national HPV vaccination program. BMC Med. 2011;9:104.CrossRefPubMedPubMedCentral
3.
Chaturvedi AK. Beyond cervical cancer: burden of other HPV-related cancers among men and women. J Adolesc Health. 2010;46(4):S20–6.CrossRefPubMed
4.
Schiffman M, Castle PE, Jeronimo J, Rodriguez AC, Wacholder S. Human papillomavirus and cervical cancer. Lancet. 2007;370(9590):890–907.CrossRefPubMed
5.
6.
Brotherton J, Zuber P, Bloem P. Primary prevention of HPV through vaccination: update on the current global status. Curr Obstet Gynecol Rep. 2016;5(3):210–24.CrossRef
7.
8.
World Health Organization. Human papillomavirus vaccines: WHO position paper, May 2017. Wkly Epidemiol Rec. 2017;19(92):241–68.
9.
World Health Organization. Report from the Global Advisory Committee on Vaccine Safety (GACVS). Wkly Epidemiol Rec. 2016;91(48):564–5.
10.
Kabakama S, Gallagher KE, Howard N, Mounier-Jack S, Burchett HE, Griffiths UK, et al. Social mobilisation, consent and acceptability: a review of human papillomavirus vaccination procedures in low and middle-income countries. BMC Public Health. 2016;16(1):834.CrossRefPubMedPubMedCentral
11.
Macartney K, Chiu C, Georgousakis M, Brotherton J. Safety of human papillomavirus vaccines: a review. Drug Saf. 2013;36:393–412.CrossRefPubMed
12.
Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schunemann HJ. What is “quality of evidence” and why is it important to clinicians? BMJ. 2008;336(7651):995–8.CrossRefPubMedPubMedCentral
13.
Jacobson RM, Adegbenro A, Pankratz VS, Poland GA. Adverse events and vaccination-the lack of power and predictability of infrequent events in pre-licensure study. Vaccine. 2001;19(17–19):2428–33.CrossRefPubMed
14.
Huang WT, Huang WI, Huang YW, Hsu CW, Chuang JH. The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: a capture-recapture analysis. Vaccine. 2012;30(12):2168–72.CrossRefPubMed
15.
16.
Tomianovic D, Bauwens J, Heininger U, Bonhoeffer J. Global vaccine safety assessment: challenges and opportunities. Paediatr Infect Dis. 2016;35:446–7.CrossRef
17.
Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the vaccine adverse event reporting system (VAERS). Vaccine. 2015;33(36):4398–405.CrossRefPubMedPubMedCentral
18.
19.
Hildesheim A, Wacholder S, Catteau G, Struyf F, Dubin G, Herrero R, et al. Efficacy of the HPV-16/18 vaccine: final according to protocol results from the blinded phase of the randomized Costa Rica HPV-16/18 vaccine trial. Vaccine. 2014;32(39):5087–97.CrossRefPubMedPubMedCentral
20.
Skinner SR, Szarewski A, Romanowski B, Garland S. Efficacy, safety and immunogenicity of the human papillomavirus 16/18 ASo4 adjuvanted vaccine in women older than 25 years: a 4 year interim follow up of the phase 3, double blind, randomised controlled VIVIANE study. Lancet. 2014;384(9961):2213–27.CrossRefPubMed
21.
Sow PS, Watson-Jones D, Kiviat N, Changalucha J, Mbaye KD, Brown J, et al. Safety and Immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-seronegative African girls and young women. J Infect Dis. 2013;207(11):1753–63.CrossRefPubMed
22.
Zhu F, Li J, Hu Y, Zhang X, Yang X, Zhao H, et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years: results from 2 randomized controlled trials. Hum Vaccin Immunother. 2014;10(7):1795–806.CrossRefPubMedPubMedCentral
23.
Zhu FC, Chen W, Hu YM, Hong Y, Li J, Zhang X, et al. Efficacy, immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese women aged 18-25 years: results from a randomized controlled trial. Int J Cancer. 2014;135(11):2612–22.CrossRefPubMedPubMedCentral
24.
Lim BK, Ng KY, Omar J, Omar SZ, Gunapalaiah B, Teoh YL, et al. Immunogenicity and safety of the AS04-adjuvanted human papillomavirus-16/18 cervical cancer vaccine in Malaysian women aged 18-35 years: a randomized controlled trial. Med J Malays. 2014;69(1):2–8.
25.
Mugo N, Ansah NA, Marino D, Saah A, Garner EI. Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa. Hum Vaccin Immunother. 2015;11(6):1323–30.CrossRefPubMedPubMedCentral
26.
Li R, Li Y, Radley D, Liu Y, Huang T, Sings HL, et al. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, double-blind, placebo-controlled trial in Chinese males and females. Vaccine. 2012;30(28):4284–91.CrossRefPubMed
27.
Clark LR, Myers ER, Huh W, Joura EA, Paavonen J, Perez G, et al. Clinical trial experience with prophylactic human papillomavirus 6/11/16/18 vaccine in young black women. J Adolesc Health. 2013;52(3):322–9.CrossRefPubMed
28.
29.
Harris T, Williams DM, Fediurek J, Scott T, Deeks SL. Adverse events following immunization in Ontario’s female school-based HPV program. Vaccine. 2014;32(9):1061–6.CrossRefPubMed
30.
Angelo MG, Zima J, Tavares Da Silva F, Baril L, Arellano F. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Pharmacoepidemiol Drug Saf. 2014;23(5):456–65.CrossRefPubMedPubMedCentral
31.
32.
Gilca V, Sauvageau C, Boulianne N, De Serres G, Crajden M, Ouakki M, et al. The effect of a booster dose of quadrivalent or bivalent HPV vaccine when administered to girls previously vaccinated with two doses of quadrivalent HPV vaccine. Hum Vaccin Immunother. 2015;11(3):732–8.CrossRefPubMedPubMedCentral
33.
Leung TF, Liu AP, Lim FS, Thollot F, Oh HM, Lee BW, et al. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: results to month 12 from a randomized trial. Hum Vaccin Immunother. 2015;11(7):1689–702.CrossRefPubMedPubMedCentral
34.
Nelson EA, Lam HS, Choi KC, Ho WC, Fung LW, Cheng FW, et al. A pilot randomized study to assess immunogenicity, reactogenicity, safety and tolerability of two human papillomavirus vaccines administered intramuscularly and intradermally to females aged 18-26 years. Vaccine. 2013;31(34):3452–60.CrossRefPubMed
35.
Sangar VC, Ghongane BB, Gupte R, Kesarkar R, Kalyan K, Chowdhary A. Comparison of post-licensure safety surveillance of bivalent and quadrivalent human papillomavirus vaccines in healthy mumbai women. Int J Pharm Pharm Sci. 2015;7(3):437–42.
36.
Angelo MG, David MP, Zima J, Baril L, Dubin G, Arellano F, et al. Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme. Pharmacoepidemiol Drug Saf. 2014;23(5):466–79.CrossRefPubMedPubMedCentral
37.
Stokley S, Jeyarajah J, Yankey D, Cano M, Gee J, Roark J, et al. Human papillomavirus vaccination coverage among adolescents, 2007–2013, and postlicensure vaccine safety monitoring, 2006–2014—United States. MMWR Morb Mortal Wkly Rep. 2014;63(29):620–4.PubMedPubMedCentral
38.
39.
Einstein MH, Takacs P, Chatterjee A, Sperling RS, Chakhtoura N, Blatter MM, et al. Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: end-of-study analysis of a phase III randomized trial. Hum Vaccin Immunother. 2014;10(12):3435–45.CrossRefPubMedPubMedCentral
40.
Einstein MH, Levin MJ, Chatterjee A, Chakhtoura N, Takacs P, Catteau G, et al. Comparative humoral and cellular immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18–45 years: follow-up through Month 48 in a phase III randomized study. Hum Vaccin Immunother. 2014;10(12):3455–65.CrossRefPubMedPubMedCentral
41.
42.
McCarthy NL, Gee J, Sukumaran L, Weintraub E, Duffy J, Kharbanda EO, et al. Vaccination and 30-day mortality risk in children, adolescents, and young adults. Pediatrics. 2016;137(3):e20152970.CrossRefPubMed
43.
Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, et al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012;166(12):1140–8.CrossRefPubMed
44.
Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015;372(8):711–23.CrossRefPubMed
45.
Moreira ED, Block SL, Ferris D, Giuliano AR, Iversen O-E, Joura EA, et al. Safety profile of the 9-valent HPV vaccine: a combined analysis of 7 phase III clinical trials. Pediatrics. 2016;128(2). (pii: e20154387).
46.
Vesikari T, Brodszki N, van Damme P, Diez-Domingo J, Icardi G, Petersen LK, et al. A randomized, double-blind, phase III study of the immunogenicity and safety of a 9-valent human papillomavirus L1 virus-like particle vaccine (V503) versus Gardasil® in 9–15-year-old girls. Pediatr Infect Dis J. 2015;34(9):992–8.CrossRefPubMed
47.
Garland SM, Cheung TH, McNeill S, Petersen LK, Romaguera J, Vazquez-Narvaez J, et al. Safety and immunogenicity of a 9-valent HPV vaccine in females 12–26 years of age who previously received the quadrivalent HPV vaccine. Vaccine. 2015;33(48):6855–64.CrossRefPubMed
48.
Kosalaraksa P, Mehlsen J, Vesikari T, Forsten A, Helm K, Van Damme P, et al. An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11–15 years of age. Pediatr Infect Dis J. 2015;34(6):627–34.CrossRefPubMed
49.
Schilling A, Parra MM, Gutierrez M, Restrepo J, Ucros S, Herrera T, et al. Coadministration of a 9-valent human papillomavirus vaccine with meningococcal and Tdap vaccines. Pediatrics. 2015;136(3):e563–72.CrossRefPubMed
50.
Gee J, Naleway A, Shui I, Baggs J, Yin R, Li R, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine. 2011;29(46):8279–84.CrossRefPubMed
51.
Rodriguez-Galan MA, Perez-Vilar S, Diez-Domingo J, Tuells J, Gomar-Fayos J, Morales-Olivas F, et al. Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007–2011). An Pediatr (Barc). 2014;81(5):303–9.CrossRefPubMed
52.
Alguacil-Ramos AM, Muelas-Tirado J, Garrigues-Pelufo TM, Portero-Alonso A, Diez-Domingo J, Pastor-Villalba E, et al. Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system. Public Health. 2016;135:66–74.CrossRefPubMed
53.
Oberle D, Pavel J, Rieck T, Weichert S, Schroten H, Keller-Stanislawski B, et al. Anaphylaxis after immunization of children and adolescents in Germany. Pediatr Infect Dis J. 2016;35(5):535–41.CrossRefPubMed
54.
55.
Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009;302(7):750–7.CrossRefPubMed
56.
Naleway AL, Crane B, Smith N, Daley MF, Donahue J, Gee J, et al. Absence of venous thromboembolism risk following quadrivalent human papillomavirus vaccination, Vaccine Safety Datalink, 2008–2011. Vaccine. 2016;34(1):167–71.CrossRefPubMed
57.
Yih WK, Greene SK, Zichittella L, Kulldorff M, Baker MA, de Jong JLO, et al. Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females. Vaccine. 2016;34(1):172–8.CrossRefPubMed
58.
Liu XC, Bell CA, Simmonds KA, Svenson LW, Russell ML. Adverse events following HPV vaccination, Alberta 2006–2014. Vaccine. 2016;34(15):1800–5.CrossRefPubMed
59.
Arnheim-Dahlstrom L, Pasternak B, Svanstrom H, Sparen P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ. 2013;347:f5906.CrossRefPubMedPubMedCentral
60.
Scheller NM, Pasternak B, Svanstrom H, Hviid A. Quadrivalent human papillomavirus vaccine and the risk of venous thromboembolism. JAMA. 2014;312(2):187–8.CrossRefPubMed
61.
Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, et al. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10–14 years. J Adolesc Health. 2012;50(2):187–94.CrossRefPubMed
62.
Lehtinen M, Paavonen J, Wheeler CM, Jaisamrarn U, Garland SM, Castellsagué X, et al. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial [erratum appears in Lancet Oncol. 2012 Jan; 13(1):e1]. Lancet Oncol. 2012;13(1):89–99.CrossRefPubMed
63.
Harper DM, Franco EL, Wheeler CM, Moscicki AB, Romanowski B, Roteli-Martins CM, et al. HPV Vaccine Study group. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet. 2006;367(9518):1247–55.CrossRefPubMed
64.
Paavonen J, Naud P, Salmeron J, Wheeler C, Chow S, Apter D, et al. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009;374(9686):301–14.CrossRefPubMed
65.
Block SL, Brown DR, Chatterjee A, Gold MA, Sings HL, Meibohm A, et al. Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine. Pediatr Infect Dis J. 2010;29(2):95–101.CrossRefPubMed
66.
Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, et al. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008;26(51):6630–8.CrossRefPubMed
67.
Tricotel A. Human papillomavirus vaccine and autoimmune disorders: a cohort study of 5.8 millions of adolescents and young women. Two years follow-up results. Fundam Clin Pharmacol. 2011;25(s1):1.
68.
Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012;271(2):193–203.CrossRefPubMed
69.
Konno R, Yoshikawa H, Okutani M, Quint W, Suryakiran PV, Lin L, et al. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women. Hum Vaccin Immunother. 2014;10(7):1781–94.CrossRefPubMedPubMedCentral
70.
Naud PS, Roteli-Martins CM, De Carvalho NS, Teixeira JC, de Borba PC, Sanchez N, et al. Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination. Hum Vaccin Immunother. 2014;10(8):2147–62.CrossRefPubMedPubMedCentral
71.
Watson-Jones D, Baisley K, Ponsiano R, Lemme F, Remes P, Ross D, et al. Human papillomavirus vaccination in Tanzanian schoolgirls: cluster-randomized trial comparing 2 vaccine-delivery strategies. J Infect Dis. 2012;206(5):678–86.CrossRefPubMedPubMedCentral
72.
Ferris D, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Reisinger KS, et al. Long-term study of a quadrivalent human papillomavirus vaccine. Pediatrics. 2014;134(3):e657–65.CrossRefPubMed
73.
Luna J, Plata M, Gonzalez M, Correa A, Maldonado I, Nossa C, et al. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil in adult women. PLoS One. 2013;8(12):e83431.CrossRefPubMedPubMedCentral
74.
Souayah N, Michas-Martin P, Nasar A, Krivitskaya N, Yacoub HA, Khan H, et al. Guillain-Barré syndrome after Gardasil vaccination: data from Vaccine Adverse Event Reporting System 2006–2009. Vaccine. 2011;29(5):886–9.CrossRefPubMed
75.
Slade BA, Gee J, Broder KR, Vellozzi C. Comment on the contribution by Souayah et al., “Guillain-Barre syndrome after Gardasil vaccination: data from Vaccine Adverse Event Reporting System 2006–2009”. Vaccine. 2011;29(5):865–6.CrossRefPubMed
76.
Scheller NM, Svanstrom H, Pasternak B, Arnheim-Dahlstrom L, Sundstrom K, Fink K, et al. Quadrivalent HPV vaccination and risk of multiple sclerosis and other demyelinating diseases of the central nervous system. JAMA. 2015;313(1):54–61.CrossRefPubMed
77.
Agence Nationale de Securite du Medicament (ANSM). Human papillomavirus vaccination and risk of auto-immune diseases: pharmaco-epidemiological study in France. France: ANSM; 2015. http://​ansm.​sante.​fr/​. Accessed Nov 2017.
78.
Miranda S, Chaignot C, Collin C, Dray-Spira R, Weill A, Zureik M. Human papillomavirus vaccination and risk of autoimmune diseases: a large cohort study of over 2 million young girls in France. Vaccine. 2017;35(36):4761–8.CrossRefPubMed
79.
80.
Grimaldi-Bensouda L, Guillemot D, Godeau B, Benichou J, Lebrun-Frenay C, Papeix C, et al. Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects. J Intern Med. 2014;275(4):398–408.CrossRefPubMed
81.
Langer-Gould A, Qian L, Tartof SY, Brara SM, Jacobsen SJ, Beaber BE, et al. Vaccines and the risk of multiple sclerosis and other central nervous system demyelinating diseases. JAMA Neurol. 2014;71(12):1506–13.CrossRefPubMed
82.
Cameron RL, Ahmed S, Pollock KGJ. Adverse event monitoring of the human papillomavirus vaccines in Scotland. Intern Med. 2016;46(4):452–7.CrossRef
83.
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;28:705–7.CrossRefPubMed
84.
Pellegrino P, Carnovale C, Perrone V, Pozzi M, Antoniazzi S, Clementi E, et al. Acute Disseminated Encephalomyelitis onset: evaluation vased on vaccine adverse events reporting systems. PLoS One. 2013;8(10):e77766.CrossRefPubMedPubMedCentral
85.
Ojha RP, Jackson BE, Tota JE, Offutt-Powell TN, Singh KP, Bae S. Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States. Hum Vaccin Immunother. 2014;10(1):2908–13.CrossRef
86.
87.
Pellegrino P, Carnovale C, Perrone V, Salvati D, Gentili M, Antoniazzi S, et al. Human papillomavirus vaccine in patients with systemic lupus erythematosus. Epidemiology. 2014;25(1):155–6.CrossRefPubMed
88.
Geier DA, Geier MR. A case-control study of quadrivalent human papillomavirus vaccine-associated autoimmune adverse events. Clin Rheumatol. 2015;34(7):1225–31.CrossRefPubMed
89.
90.
Yamamoto Y, Kazebayashi Y, Hirai N, Sasaki T, Ohsaki Y. Interstitial lung disease associated with human papillomavirus vaccination. Respir Med Case Rep. 2015;16:15–7.PubMedPubMedCentral
91.
Cerami C, Corbo M, Piccolo G, Iannaccone S. Autoimmune neuromyotonia following human papilloma virus vaccination. Muscle Nerve. 2013;47(3):466–7.CrossRefPubMed
92.
Sawai T, Shimizu M, Sakai T, Yachie A. Tubulointerstitial nephritis and uveitis syndrome associated with human papillomavirus vaccine. J Pediatr Ophthalmol Strabismus. 2016;53(3):190–1.CrossRefPubMed
93.
Holt HD, Hinkle DM, Falk NS, Fraunfelder FT, Fraunfelder FW. Human papilloma virus vaccine associated uveitis. Curr Drug Saf. 2014;9(1):65–8.CrossRefPubMed
94.
Colafrancesco S, Perricone C, Tomljenovic L, Shoenfeld Y. Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants. Am J Reprod Immunol. 2013;70(4):309–16.CrossRefPubMed
95.
96.
Hawkes D, Buttery JP. Human papillomavirus vaccination and primary ovarian insufficiency: an association based on ideology rather than evidence. Curr Opin Obstet Gynecol. 2016;28(1):70–2.CrossRefPubMed
97.
Pellegrino P, Carnovale C, Perrone V, Salvati D, Gentiti M, Busadelli T, et al. On the association between human papillomavirus vaccine and primary ovarian failure [letter]. Am J Reprod Immunol. 2013;71(4):293–4.CrossRefPubMed
98.
Gee J, Weinbaum C, Sukumaran L, Markowitz LE. Quadrivalent HPV vaccine safety review and safety monitoring plans for nine-valent HPV vaccine in the United States. Hum Vaccin Immunother. 2016;12(6):1406–17.CrossRefPubMedPubMedCentral
99.
Pellegrino P, Perrone V, Pozzi M, Carnovale C, Perrotta C, Clementi E, et al. The epidemiological profile of ASIA syndrome after HPV vaccination: an evaluation based on the vaccine adverse event reporting systems. Immunol Res. 2015;61(1–2):90–6.CrossRefPubMed
100.
Hawkes D, Benhamu J, Sidwell T, Miles R, Dunlop RA. Revisiting adverse reactions to vaccines: a critical appraisal of Autoimmune Syndrome Induced by Adjuvants (ASIA). J Autoimmun. 2015;59:77–84.CrossRefPubMed
101.
102.
Poddighe D, Castelli L, Marseglia GL, Bruni P. A sudden onset of a pseudo-neurological syndrome after HPV-16/18 AS04-adjuvated vaccine: might it be an autoimmune/inflammatory syndrome induced by adjuvants (ASIA) presenting as a somatoform disorder? Immunol Res. 2014;60(2–3):236–46.CrossRefPubMed
103.
Anaya JM, Reyes B, Perdomo-Arciniegas AM, Camacho-Rodriguez B, Rojas-Villarraga A. Autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA) after quadrivalent human papillomavirus vaccination in Colombians: a call for personalised medicine. Clin Exp Rheumatol. 2015;33(4):545–8.PubMed
104.
105.
106.
Lee SH. Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil. J Inorg Biochem. 2012;117:85–92.CrossRefPubMed
107.
108.
109.
Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, et al. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007;26(3):201–9.CrossRefPubMed
110.
Woo EJ, Winiecki SK, Ou AC. Motor palsies of cranial nerves (excluding VII) after vaccination reports to the US Vaccine Adverse Event Reporting System. Hum Vaccin Immunother. 2014;10(2):301–5.CrossRefPubMed
111.
112.
Donegan K, Beau-Lejdstrom R, King B, Seabroke S, Thomson A, Bryan P. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK. Vaccine. 2013;31(43):4961–7.CrossRefPubMed
113.
Kinoshita T, Abe R, Hineno A, Tsunekawa K, Nakane S, Ikeda S. Perpheral sympathetic nerve dysfunction in adolescent japanese girls following immunisation with the human papillomavirus vaccine. Intern Med. 2014;53(19):2185–200.CrossRefPubMed
114.
Martinez-Lavin M, Martinez-Martinez LA, Reyes-Loyola P. HPV vaccination syndrome. A questionnaire-based study. Clin Rheumatol. 2015;34(11):1981–3.CrossRefPubMed
115.
Petousis-Harris H. Proposed HPV vaccination syndrome is unsubstantiated. Clin Rheumatol. 2016;35(3):833–4.CrossRefPubMed
116.
Brinth LS, Pors K, Theibel AC, Mehlsen J. Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papilloma virus. Vaccine. 2015;33(22):2602–5.CrossRefPubMed
117.
Brinth L, Theibel AC, Pors K, Mehlsen J. Suspected side effects to the quadrivalent human papilloma vaccine. Dan Med J. 2015;62(4):1–5.
118.
Garland SM, Molesworth EG, Machalek DA, Cornall AM, Tabrizi SN. How to best measure the effectiveness of male human papillomavirus vaccine programmes? Clin Microbiol Infect. 2015;21(9):834–41.CrossRefPubMed
119.
Huygen F, Verschueren K, McCabe C, Stegmann JU, Zima J, Mahaux O, et al. Investigating reports of complex regional pain syndrome: an analysis of HPV-16/18-adjuvanted vaccine post-licensure data. EBioMedicine. 2015;2(9):1114–21.CrossRefPubMedPubMedCentral
120.
Baxter R, Lewis N, Bohrer P, Harrington T, Aukes L, Klein NP. Sudden-onset sensorineural hearing loss after immunization: a case-centered analysis. Otolaryngol Head Neck Surg. 2016;155(1):81–6.CrossRefPubMed
121.
Schurink-Van’t Klooster TM, de Ridder MAJ, Kemmeren JM, van der Lei J, Dekker F, Sturkenboom M, et al. Examining a possible association between human papilloma virus (HPV) vaccination and migraine: results of a cohort study in the Netherlands. Eur J Pediatr. 2015;174(5):641–9.CrossRefPubMed
122.
Giuliano AR, Isaacs-Soriano K, Torres BN, Abrahamsen M, Ingles DJ, Sirak BA, et al. Immunogenicity and safety of Gardasil among mid-adult aged men (27–45 years)—the MAM study. Vaccine. 2015;33(42):5640–6.CrossRefPubMed
123.
Castellsagué X, Giuliano AR, Goldstone S, Guevara A, Mogensen O, Palefsky JM, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892–901.CrossRefPubMed
124.
Van Damme P, Olsson SE, Block S, Castellsague X, Gray GE, Herrera T, et al. Immunogenicity and safety of a 9-valent HPV vaccine. Pediatrics. 2015;136(1):e28–39.CrossRefPubMed
125.
Moro PL, Zheteyeva Y, Lewis P, Shi J, Yue X, Museru OI, et al. Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006–2013. Vaccine. 2015;33(4):519–22.CrossRefPubMed
126.
Goss MA, Lievano F, Buchanan KM, Seminack MM, Cunningham ML, Dana A. Final report on exposure during pregnancy from a pregnancy registry for quadrivalent human papillomavirus vaccine. Vaccine. 2015;33(29):3422–8.CrossRefPubMed
127.
Baril L, Rosillon D, Willame C, Angelo MG, Zima J, van den Bosch JH, et al. Risk of spontaneous abortion and other pregnancy outcomes in 15–25 year old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom. Vaccine. 2015;33(48):6884–91.CrossRefPubMed
128.
Mok CC, Ho LY, Fong LS, To CH. Immunogenicity and safety of a quadrivalent human papillomavirus vaccine in patients with systemic lupus erythematosus: a case-control study. Ann Rheum Dis. 2013;72(5):659–64.CrossRefPubMed
129.
Soybilgic A, Onel KB, Utset T, Alexander K, Wagner-Weiner L. Safety and immunogenicity of the quadrivalent HPV vaccine in female systemic lupus erythematosus patients aged 12 to 26 years. Pediatr Rheumatol Online J. 2013;11:29.CrossRefPubMedPubMedCentral
130.
Esposito S, Corona F, Barzon L, Cuoco F, Squarzon L, Marcati G, et al. Immunogenicity, safety and tolerability of a bivalent human papillomavirus vaccine in adolescents with juvenile idiopathic arthritis. Expert Rev Vaccines. 2014;13(11):1387–93.CrossRefPubMed
131.
Jacobson DL, Bousvaros A, Ashworth L, Carey R, Shrier LA, Burchett SK, et al. Immunogenicity and tolerability to human papillomavirus-like particle vaccine in girls and young women with inflammatory bowel disease. Inflamm Bowel Dis. 2013;19(7):1441–9.CrossRefPubMedPubMedCentral
132.
Denny L, Hendricks B, Gordon C, Thomas F, Hezareh M, Dobbelaere K, et al. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in HIV-positive women in South Africa: a partially-blind randomised placebo-controlled study. Vaccine. 2013;31(48):5745–53.CrossRefPubMed
133.
Giacomet V, Penagini F, Trabattoni D, Vigano A, Rainone V, Bernazzani G, et al. Safety and immunogenicity of a quadrivalent human papillomavirus vaccine in HIV-infected and HIV-negative adolescents and young adults. Vaccine. 2014;32(43):5657–61.CrossRefPubMed
134.
Toft L, Storgaard M, Muller M, Sehr P, Bonde J, Tolstrup M, et al. Comparison of the immunogenicity and reactogenicity of Cervarix and Gardasil human papillomavirus vaccines in HIV-infected adults: a randomized, double-blind clinical trial. J Infect Dis. 2014;209(8):1165–73.CrossRefPubMed
135.
Kahn JA, Xu J, Kapogiannis BG, Rudy B, Gonin R, Liu N, et al. Immunogenicity and safety of the human papillomavirus 6, 11, 16, 18 vaccine in HIV-infected young women. Clin Infect Dis. 2013;57(5):735–44.CrossRefPubMedPubMedCentral
136.
Kojic EM, Kang M, Cespedes MS, Umbleja T, Godfrey C, Allen RT, et al. Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women. Clin Infect Dis. 2014;59(1):127–35.CrossRefPubMedPubMedCentral
137.
World Health Organization. Meeting of the Global Advisory Committee on Vaccine Safety, 7–8 June 2017. Wkly Epidemiol Rec. 2017;92(28):393–404.
138.
139.
Ozawa K, Hineno A, Kinoshita T, Ishihara S, Ikeda SI. Suspected adverse effects after human papillomavirus vaccination: a temporal relationship between vaccine administration and the appearance of symptoms in Japan. Drug Saf. 2017;40(12):1219–29.CrossRefPubMedPubMedCentral
140.
Chandler RE, Juhlin K, Fransson J, Caster O, Edwards IR, Noren GN. Current safety concerns with human papillomavirus vccine: a cluster analysis of reports in VigiBase®. Drug Saf. 2017;40(1):81–90.CrossRefPubMed
141.
Grimaldi-Bensouda L, Rossignol M, Kone-Paut I, Krivitzky A, Lebrun-Frenay C, Clet J, et al. Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: six years of case-referent surveillance. J Autoimmun. 2017;79:84–90.CrossRefPubMed
142.
Andrews N, Stowe J, Miller E. No increased risk of Guillain-Barre syndrome after human papilloma virus vaccine: a self-controlled case-series study in England. Vaccine. 2017;35(13):1729–32.CrossRefPubMed
143.
Gronlund O, Herweijer E, Sundstrom K, Arnheim-Dahlstrom L. Incidence of new-onset autoimmune disease in girls and women with pre-existing autoimmune disease after quadrivalent human papillomavirus vaccination: a cohort study. J Int Med. 2016;280:618–26.CrossRef
144.
Willame C, Rosillon D, Zima J, Angelo MG, Stuurman AL, Vroling H, et al. 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. Hum Vaccin Immunother. 2016;12(11):2862–71.CrossRefPubMedPubMedCentral
145.
Scheller NM, Pasternak B, Mølgaard-Nielsen D, Svanström H, Hviid A. Quadrivalent HPV vaccination and the risk of adverse pregnancy outcomes. N Engl J Med. 2017;376(13):1223–33.CrossRefPubMed
146.
147.
Centers for Disease Control and Prevention (CDC), the food and drug administration (FDA), agencies of the U.S. Department of Health and Human Services. Vaccine Adverse Events Reporting System. 2012. http://​vaers.​hhs.​gov/​index. Accessed 1 May 2017.
148.
Coelho PL, da Silva Calestini GL, Alvo FS, de Moura Freitas JM, Castro PM, Konstantyner T. Safety of human papillomavirus 6, 11, 16 and 18 (recombinant): systematic review and meta-analysis. Rev Paul Pediatr. 2015;33(4):474–82.CrossRefPubMedPubMedCentral
149.
Vichnin M, Bonanni P, Klein NP, Garland SM, Block SL, Kjaer SK, et al. An overview of quadrivalent human papillomavirus vaccine safety: 2006 to 2015. Pediatr Infect Dis J. 2015;34(9):983–91.CrossRefPubMed
150.
Balshem H, Helfand M, Schunemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64(4):401–6.CrossRefPubMed
151.
Hung BT, Long NP, le Hung P, Luan NT, Anh NH, Nghi TD, et al. Research trends in evidence-based medicine: a joinpoint regression analysis of more than 50 years of publication data. PLoS One. 2015;10(4):e0121054.CrossRefPubMedPubMedCentral
152.
153.
Hanley SJB, Yoshioka E, Ito Y, Kishi R. HPV vaccination crisis in Japan [letter]. Lancet. 2015;385(9987):2571.CrossRefPubMed
154.
155.
Darden PM, Thompson DM, Roberts JR, Hale JJ, Pope C, Naifeh M, et al. Reasons for not vaccinating adolescents: national Immunization Survey of Teens, 2008–2010. Pediatrics. 2013;131(4):645–51.CrossRefPubMed
156.
Garland SM, Kjaer S, Munoz N, Block S, Brown D, DiNubile MJ, et al. Impact and effectiveness of the quadrivalent human papillomavirus vaccine: a systematic review of 10 Years of real-world experience. Clin Infect Dis. 2016;63(4):519–27.CrossRefPubMedPubMedCentral
157.
Metadaten
Titel
Safety of Human Papillomavirus Vaccines: An Updated Review
verfasst von
Anastasia Phillips
Cyra Patel
Alexis Pillsbury
Julia Brotherton
Kristine Macartney
Publikationsdatum
01.04.2018
Verlag
Springer International Publishing
Erschienen in
Drug Safety / Ausgabe 4/2018
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-017-0625-z

Weitere Artikel der Ausgabe 4/2018

Drug Safety 4/2018 Zur Ausgabe

short communication

Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors

Original Research Article

Cardiovascular Profile of Valbenazine: Analysis of Pooled Data from Three Randomized, Double-Blind, Placebo-Controlled Trials

Original Research Article

Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs

Commentary

The Safety of Generic Prescription Drugs in the United States

Therapy in Practice

Management Strategies to Facilitate Optimal Outcomes for Patients Treated with Delayed-release Dimethyl Fumarate

Original Research Article

Amyotrophic Lateral Sclerosis Associated with Statin Use: A Disproportionality Analysis of the FDA’s Adverse Event Reporting System