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DESCRIBEN LA APLICACION DE LA VACUNA BIVALENTE CONTRA EL CANCER DE CUELLO UTERINO

(especial para SIIC © Derechos reservados)
Aseguran que la mayor utilidad de la vacuna bivalente contra el HPV sería para las mujeres que no se someten rutinariamente a los programas de tamizaje.
Autor:
Diane m Harper
Columnista Experta de SIIC

Institución:
University of Missouri-Kansas

Artículos publicados por Diane m Harper
Recepción del artículo
17 de Enero, 2011 		Aprobación
23 de Junio, 2011
Primera edición
15 de Noviembre, 2011 		Segunda edición, ampliada y corregida
7 de Junio, 2021

DESCRIBEN LA APLICACION DE LA VACUNA BIVALENTE CONTRA EL CANCER DE CUELLO UTERINO

Resumen
Casi medio millón de mujeres en todo el mundo presentan cáncer de cuello uterino cada año,1 el 80% de estas mujeres se encuentran en países sin una garantía de calidad del programa de tamizaje por citología. Es en este contexto que la vacuna bivalente podría reducir la incidencia de cáncer de cuello uterino en alrededor de 9.5/100 000 mujeres. Existen nuevos datos que indican que esto podría lograrse con una sola dosis de la vacuna bivalente, una gran ventaja para los programas de aplicación en salud pública.2 En los países con los programas de cribado, el adenocarcinoma es el cáncer más difícil de detectar y tratar, ya que se presenta en forma tardía y con una mayor mortalidad.3,4 Con una protección cruzada adicional para el HPV 31, 33 y 45, y la protección contra el HPV 16 y 18 de al menos 8.4 años de duración, la vacuna bivalente puede reducir más del 90% de los adenocarcinomas en las mujeres de las poblaciones seleccionadas. En esta revisión se detalla la información sobre la eficacia, inmunogenicidad y seguridad de la vacuna bivalente en las poblaciones estudiadas, y se contrastan los objetivos en el plano de la salud pública con las opciones de salud a nivel individual.

Palabras clave
vacuna bivalente, cáncer de cuello uterino, prevención, inmunogenicidad, CIN 2/3, adenocarcinoma, detección, mujeres maduras, adolescentes, mujeres jóvenes


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Bivalent HPV Vaccine approved for cervical cancer prevention in females

Abstract
Nearly a half a million women throughout the world develop cervical cancer every year;1 80% of these women are in countries without a quality assured cytology screening program. It is in this setting that bivalent HPV vacine could reduce the incidence of cervical cancer to about 9.5/100 000 women. New evidence indicates that this might be able to be accomplished with a single dose of bivalent HPV vaccine, a great advantage to public health implementation programs.2

In countries with screening programs, adenocarcinoma is the most difficult to detect and treat with later stage presentation and higher mortality.3,4 With additional cross protection to HPV 31, 33 and 45, and protection against HPV 16 and 18 lasting at least 8.4 years, bivalent HPC vaccine may reduce adenocarcinomas in screened populations by more than 90%.

This review will detail the evidence about the efficacy, immunogenicity and safety of bivalent HPV vaccine in the studied populations contrasting public health goals with individual health options.

Key words
bivalent HPV vaccine, cervical cancer, prevention, immunogenicity, CIN 2/3, adenocarcinoma, screening, mature women, adolescent girls, young women


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Especialidades
Principal: Infectología, Obstetricia y Ginecología
Relacionadas: Anatomía Patológica, Atención Primaria, Inmunología, Medicina Familiar, Medicina Interna, Oncología, Pediatría, Salud Pública



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Enviar correspondencia a:
Diane M Harper, University of Missouri-Kansas School of Medicine, MO 64139, 7900 Lee's Summit Road, Kansas, EE.UU.
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105. **De Carvalho N, Teixeira J, Roteli-Martins CM, Naud P, De Borba P, Zahaf T, Sanchez N, Schuind A. Sustained efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine up to 7.3 years in young adult women. Vaccine 28(38):6247-6255, 2010.
**This reference documents the longest term published efficacy for Cervarix.

106. The GlaxoSmithKline Vaccine HPV-023 Study Group. Sustained efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 8.4 years. Abstract #632 Presented at ESPID, May 4-8, 2010.

107. Romanowski B for PATRICIA Study Group. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against non-vaccine oncogenic HPV types: end-of-study results. Presented at 26th International Papillomavirus Conference, Montreal, Canada, July 3-8, 2010.

108. Poppe W, Paavonen J, Naud P, Salmerón J, Chow SN, Apter D, et al. Vaccine efficacy with/without evidence of prior HPV-16/18 infection: analysis of PATRICIA, a phase III trial with AS04-adjuvanted HVP 16/18 vaccine. Presented at ESGO poster #115 Belgrade, Serbia October 11-14, 2009.

109. Schiffman M, Safaeian M, Wentzensen N. The use of human papillomavirus seroepidemiology to inform vaccine policy. Sexually Transmitted Diseases 36:675-679, 2009.

110. Smith EM, Parker MA, Rubenstein LM, Haugen TH, Hamsikova E, Turek LP. Evidence for vertical transmission of HPV from mothers to infants. Infect Dis Obstet Gynecol. Article ID 326369, 7 pages. doi:10.1155/2010/326369 (2010).

111. Arbyn M, Simoens C, Van Damme P, Scharpantgen A, Meijer CJ, Beutels P. Introduction of Human Papillomavirus Vaccination in Belgium, Luxembourg and the Netherlands. Gynecol Obstet Invest 70(4):224-232, 2010.

112. *Harper DM, Franco EL, Wheeler CM, et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 364:1757-65, 2004.
*First report of Cervarix' efficacy.

113. Harper DM, Franco EL, Wheeler CM, Moscicki AB, Romanowski B, Roteli-Martins CM, et al. 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 367(9518):1247-55, 2006.

114. **Schwarz TF, Spaczynski M, Schneider A, Wysocki J, Galaj A, Perona P, Poncelet S, Zahaf T, Hardt K, Descamps D, Dubin G on behalf of the HPV Study Group for Adult Women. Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years. Vaccine 27:581-587, 2009.
**Outstanding reference for long term immunogenicity of Cervarix in older women through 55 years.

115. Pedersen C, Petaja T, Strauss G, et al. Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant. Journal of Adolescent Health 40:564-71, 2007.

116. Schwarz TF, Huang LM, Rivera Medina DM, Valencia A, Yien LT, Behre U, Catteau G, Thomas F, Descamps D. 4-Year follow up of immunogenicity and safety of adolescent girls vaccinated with the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine. 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID): Nice, France, May 4-8, 2010.

117. Hildesheim A, Herrero R, Wacholder S, Rodriguez AC, Solomon D, Bratti MC, et al. Effect of human papillomavirus 16/18 L1 viruslike particle vaccine among young women with preexisting infection: a randomized trial. JAMA 298(7):743-53, 2007.

118. **Pacher SK, Rosenthal HE, Perlitz H, Feger T, Kastner U, Schneider A, et al. Direct Longitudinal comparison over 12 month of T cell responses to prophylactic HPV vaccines. Presented at 26th International Papillomavirus Conference, Montreal, Canada, July 3-8, 2010.
** Critical report of the immunologic response of Cervarix to be superior to Gardasil and to offer HPV 6 and 11 immune responses.

119. Einstein MH, on behalf of the HPV-010 Study Group. Immunogenicity comparison of two prophylactic human papillomavirus cervical cancer vaccines at month 18. Presentation number PS 3-4. EuroGin, Feb 17-20, 2010, Monte Carlo, Monaco.

120. Roteli-Martins CM, Naud P, De Borba P, Teixeira J, De Carvalho N, et al. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine. Abstract Number 632 ESPID, May 4-8, 2010.

121. ** Dessy F, Poncelet S, Xhenseval V, Méric D, Dubin G on behalf of the HPV-010 Study Group. Comparative evaluation of the immunogenicity of two prophylactic HPV cervical cancer vaccines by Merck's competitive Luminex immunoassay (cLIA) and GSK's binding ELISA. Presentation # P IM-5. EuroGin, Monte Carlo, Monaco, Feb 17-20, 2009.
**Critical reference to put to rest discussions about immunologic titers compared in different assay systems.

122. Schiller JT, Davies P. Delivering on the promise: HPV vaccines and cervical cancer. Nat Rev Microbiol 2(4):343-7, 2004.

123. Nardelli-Haefliger D, Wirthner D, Schiller JT, Lowy DR, Hildesheim A, Ponci F, et al. Specific antibody levels at the cervix during the menstrual cycle of women vaccinated with human papillomavirus 16 virus-like particles. J Natl Cancer Inst 95(15):1128-37, 2003.

124. Paavonen J, Jenkins D, Bosch FX, et al: Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet 369:2161-2170, 2007.

125. *Harper DM. Primary Prevention of HPV-Associated Diseases. Public Health Genomics 12:319-330, 2009.
*This reference brings to light the same immunologic responses for seropositive as seronegative women after HPV vaccination, an important concept that allows effective vaccination to those already HPV exposed.

126. Schwarz TF, Spaczynski M, Schneider A, Wysocki J, Galaj A, Schulze K, Poncelet S, Catteau G, Thomas F, Descamps D. Long-term persistence of immune response to HPV-16/18 AS04-adjuvanted cervical cancer vaccine in women aged 15-55 years. Abstract O-6.3 Presented at AOGIN, New Delhi, India, March 26-28, 2010.

127. Romanowski B, Schwarz T, Ferguson L, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemans P, Ebert R, Catteau G, Descamps D, Schuind A. HPV-16/18 AS04-adjuvanted vaccine administered as a 2 dose schedule compared with the standard 3 dose schedule. Abstract SS 11-5. EuroGin 2010, Monte Carlo, Monaco.

128. Petaja T, Keränen H, Karppa T, Kawa A, Lantela S, Siitari-Mattila M, Levänen H, Tocklin T, Godeaux O, Lehtinen M, Dubin G. Immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy boys aged 10-18 years. J Adolesc Health 44(1):33-40, 2009.

129. Garcia-Sicilia J, Schwarz TF, Carmona A, Peters K, Malkin JE, Tran PM, Behre U, Iturbe EB, Catteau G, Thomas F, Dobbelaere K, Descamps D, Dubin G; HPV Vaccine Adolescent Study Investigators Network. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine co-administered with combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine to girls and young women. J Adolesc Health 46(2):142-51, 2010.

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131. Szarewski A, Lazcano E, Angsuwathana S, et al. Safety of human papillomavirus (HPV) 16/18 AS04 cervical cancer vaccine candidate in women aged 26 years or older. The HPV VIVIANE study group [abstract no. SS2-4]. EuroGin. Monte Carlo, Monaco Oct 4-6, 2007.

132. Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 ASO4-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccine 5:332-40, 2009.

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*An important study from the policy angle on HPV vaccination.

137. Harper DM, Paavonen J. Age for HPV vaccination. Vaccine 26 Suppl 1:A7-11, 2008.

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