Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study

Skinner, S. Rachel; Szarewski, Anne; Romanowski, Barbara; Garland, Suzanne M.; Lazcano‐Ponce, Eduardo; Salmerón, Jorge; Rosario-Raymundo, Maria Rowena Del; Verheijen, René H.M.; Quek, Swee Chong; Silva, Daniel P. da; Kitchener, Henry C; Fong, Kah Leng; Bouchard, Céline; Money, Deborah; Ilancheran, A.; Cruickshank, Margaret; Levin, Myron J.; Chatterjee, Archana; Stapleton, Jack T.; Martens, Mark G.; Quint, Wim; David, Marie Pierre; Meric, Dorothée; Hardt, Karin; Descamps, Dominique; Geeraerts, Brecht; Struyf, Frank; Dubin, Gary

doi:10.1016/s0140-6736(14)60920-x

Cited by 160 publications

(152 citation statements)

References 37 publications

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“…This study included a subset of women with a history of HPV infection or disease, and as such, supported the contention that women older than 25 y can also benefit from HPV vaccination when they have been previously exposed to HPV. 41 Furthermore, decreasing efficacy with age was observed in the ITT population in the Costa Rica HPV trial, where the efficacy fell from 68.9% (95% CI 53.1-79.9) in women aged 18-19 y, to 21.8% (95% CI: 16.9, 47.9) in 24-25 year-olds. 42 Similar findings were observed for the quadrivalent HPV vaccine in a study including over 2.2 million females aged 10-44 y, where increased vaccine effectiveness with decreasing age was noted.…”

Section: Human Papillomavirus (Hpv) Vaccinationmentioning

confidence: 96%

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Recommended immunization schedules for adults: Clinical practice guidelines by the Escmid Vaccine Study Group (EVASG), European Geriatric Medicine Society (EUGMS) and the World Association for Infectious Diseases and Immunological Disorders (WAidid)

Esposito

Bonanni

Maggi

et al. 2016

Human Vaccines & Immunotherapeutics

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Rapid population aging has become a major challenge in the industrialized world and progressive aging is a key reason for making improvement in vaccination a cornerstone of public health strategy. An increase in age-related disorders and conditions is likely to be seen in the near future, and these are risk factors for the occurrence of a number of vaccine-preventable diseases. An improvement in infectious diseases prevention specifically aimed at adults and the elderly can therefore also decrease the burden of these chronic conditions by reducing morbidity, disability, hospital admissions, health costs, mortality rates and, perhaps most importantly, by improving the quality of life. Among adults, it is necessary to identify groups at increased risk of vaccine-preventable diseases and highlight the epidemiological impact and benefits of vaccinations using an evidence-based approach. This document provides clinical practice guidance on immunization for adults in order to provide recommendations for decision makers and healthcare workers in Europe. Although immunization is considered one of the most impactful and cost-effective public health measures that can be undertaken, vaccination coverage rates among adults are largely lower than the stated goal of 95% among adults, and stronger efforts are needed to increase coverage in this population. Active surveillance of adult vaccine-preventable diseases, determining the effectiveness of the vaccines approved for marketing in the last 5 y, the efficacy and safety of vaccines in immunocompromised patients, as well as in pregnant women, represent the priorities for future research.

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Section: Human Papillomavirus (Hpv) Vaccinationmentioning

confidence: 96%

“…[41][42][43][44] However, episodes of mass psychogenic syndrome have been reported and it is therefore important to carefully plan the setting where mass vaccination campaigns will be implemented.…”

Section: Human Papillomavirus (Hpv) Vaccinationmentioning

confidence: 99%

Recommended immunization schedules for adults: Clinical practice guidelines by the Escmid Vaccine Study Group (EVASG), European Geriatric Medicine Society (EUGMS) and the World Association for Infectious Diseases and Immunological Disorders (WAidid)

Esposito

Bonanni

Maggi

et al. 2016

Human Vaccines & Immunotherapeutics

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“…Skinner and colleagues affirm that prophylactic HPV vaccination is safe and prevents the acquisition of target HPV genotypes at any age, and that woman of any age could gain some potential benefit from HPV vaccination. 18 Vaccine resistance…”

Section: Vaccination Beyond 26 Years and In Hpv Infected Populationmentioning

confidence: 99%

HPV vaccine: Current status and future directions

Kumar

Biswas

Jose

2015

Medical Journal Armed Forces India

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Viral like particles (VLP) and hence highly species specific, thermolabile, costly and are purely prophylactic. The quest for a cheaper, thermostable and broad spectrum vaccine has led to many newer prophylactic vaccines. Therapeutic vaccines were born out of the inescapable necessity considering high HPV related morbidity projected in the non HPV naïve population. Therapeutic vaccines would immediately reduce this burden and also help in the management of HPV related cancers alone or as part of combination strategies.Ongoing research is aimed at a total control over HPV related malignancies in the near future.

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“…5 A infeção pelo HPV é condição necessária na quase totalidade dos casos de CCU, [5][6][7][8][9][10] existindo mais de 100 genótipos do HPV estudados; 90% dos casos de CCU são provocados pelos genótipos de alto risco (oncogénicos) 16,18,45,31,33,52, 58 e 35. 5,[10][11][12][13][14] A infeção pelos genótipos 16 e 18 está na origem da grande maioria dos casos de CCU Revista Científica da Ordem dos Médicos www.actamedicaportuguesa.com Ribeiro JP, et al Eficácia das vacinas contra o HPV nas mulheres com mais de 24 anos na prevenção do CCU, Acta Med Port 2016 Jun;29 (6): [401][402][403][404][405][406][407][408] -mais de 70% dos casos, 5,6,10,[14][15][16][17] enquanto aproximadamente 10% são consequência da infeção pelos genótipos 45 e 31, 15 e os restantes são causados por outros genóti-pos oncogénicos. Esta infeção é uma doença sexualmente transmissível, representando uma das mais comuns, 11,12,14 o genótipo 16 é o mais prevalente, 12 apesar de existir variação geográfica na prevalência dos genótipos.…”

Section: Introductionunclassified

“…18,19 A maioria das infeções por HPV é transitória, 6,15 ocorrendo resolução espontânea em 90% dos casos após dois anos, 15 que, no entanto, não confere imunidade contra a infeção pelo vírus. 6,9,12,13,15,16 A eficácia das vacinas contra o HPV nas mulheres até aos 25 anos de idade está bem comprovada, 10,11,16,17,19 porém, a eficácia em idades superiores ainda não está totalmente estabelecida e existem dúvidas quanto à sua utilização.…”

Section: Introductionunclassified

Eficácia das Vacinas Contra o Vírus do Papiloma Humano nas Mulheres com mais de 24 Anos na Prevenção do Cancro do Colo do Útero

Ribeiro¹,

Borges²

2016

Acta Med Port

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Introduction: Cervix cancer is the fourth most common female cancer and the second most frequent in women aged 15 to 44 years. The infection by the human papillomavirus is a necessary condition in almost all of cervix cancer cases; it is a sexually transmitted disease and all women sexually active are at risk of being infected. There are currently three vaccines against human papillomavirus, and despite of the efficacy being well proven in woman aged up to 25 years, it is not well established in older ages. Material and Methods: It was performed a literature review of the current evidence about the efficacy of the vaccines against human papillomavirus in women older than 24 years in the cervix cancer prevention, and was assessed the evidence quality by the GRADE system. Results: Two randomized controlled trials were identified with a total of 9,571 participants – 4,792 vaccinated and 4,779 at the control group and reported data of 48 months period follow-up. The relative risk reduction was 41% (95% CI: 29 a 50%) – for the vaccinated group. There were no differences in safety and tolerability between the two groups – vaccine and control. Conclusion: The actual evidence shows that the vaccines against human papillomavirus 16 and/or 18 in women older than 24 until 45 years have an important efficacy at reducing the risk of having persistent infection and/or to acquire cervix cancer precursor lesions.

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Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study

Cited by 160 publications

References 37 publications

Recommended immunization schedules for adults: Clinical practice guidelines by the Escmid Vaccine Study Group (EVASG), European Geriatric Medicine Society (EUGMS) and the World Association for Infectious Diseases and Immunological Disorders (WAidid)

Recommended immunization schedules for adults: Clinical practice guidelines by the Escmid Vaccine Study Group (EVASG), European Geriatric Medicine Society (EUGMS) and the World Association for Infectious Diseases and Immunological Disorders (WAidid)

HPV vaccine: Current status and future directions

Eficácia das Vacinas Contra o Vírus do Papiloma Humano nas Mulheres com mais de 24 Anos na Prevenção do Cancro do Colo do Útero

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