Is human papillomavirus vaccination likely to be a useful strategy in India?

Sudeep Gupta; Rajendra A. Kerkar; Rajesh Dikshit; Rajendra A. Badwe

doi:10.4103/2278-330X.119887

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THE GREAT DEBATE: Against HPV vaccine in cervical cancer

02 (

); 193-197

doi:

10.4103/2278-330X.119887

Is human papillomavirus vaccination likely to be a useful strategy in India?

Sudeep Gupta¹, Rajendra A. Kerkar², Rajesh Dikshit³, Rajendra A. Badwe^2,

1 Department of Medical Oncology Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India

2 Department of Surgical Oncology Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India

3 Department of Epidemiology, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India

*Corresponding author: Dr. Rajendra A. Badwe. badwera@tmc.gov.in

Published: 2020-12-31

MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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Abstract

Two vaccines that protect against infection by some of the oncogenic human papillomavirus (HPV) subtypes have recently been licensed for use in population-based vaccination strategies in many countries. However, these products are being promoted as ‘cervical cancer vaccines’ based on inadequate data. Specifically, there remain several concerns about the duration of immunogenicity, length of follow-up of trial subjects, endpoints chosen in vaccine trials, applicability of trial results to real populations, the safety of these products, and their cost-effectiveness as public health interventions. Furthermore, it is unlikely that vaccination will obviate the need for setting up robust and cost-effective screening programs in countries like India. This article will discuss various aspects of HPV vaccination from a public health perspective, especially from the point of view of its relevance to India and other South Asian countries.

Keywords

References

de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, et al. Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: A retrospective cross-sectional worldwide study. Lancet Oncol 2010;11:1048-56.
Gillison ML, Chaturvedi AK, Lowy DR. HPV prophylactic vaccines and the potential prevention of noncervical cancers in both men and women. Cancer 2008;113 (10 Suppl):3036-46.
Garland SM, Steben M, Sings HL, James M, Lu S, Railkar R, et al. Natural history of genital warts: Analysis of the placebo arm of 2 randomized phase III trials of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine. J Infect Dis 2009;199:805-14.
Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, et al. Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med 2007;356:1928-43.
FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007;356:1915-27.
Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeron J, Wheeler CM, et al. HPV PATRICIA study group. 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, randomized controlled trial. Lancet 2007;369:2161-70.
Herrero R, Hildesheim A, Rodriguez AC, Wacholder S, Bratti C, Solomon D, et al. Costa Rica Vaccine Trial (CVT) Group. Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica. Vaccine 2008;26:4795-808.
Castellsague X, Munoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K, et al. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. Br J Cancer 2011;105:28-37.
Lehtinen M, Paavonen J, Wheeler CM, Jaisamrarn U, Garland SM, Castellsague X, et al. HPV PATRICIA Study Group. 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 randomized, double-blind PATRICIA trial. Lancet Oncol 2012;13:89-99.
Wheeler CM, Castellsague X, Garland SM, Szarewski A, Paavonen J, Naud P, et al. HPV PATRICIA Study Group. 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 randomized, double-blind PATRICIA trial. Lancet Oncol 2012;13:100-10.
Kjaer SK, Frederiksen K, Munk C, Iftner T. Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: Role of persistence. J Natl Cancer Inst 2010;102:1478-88.
Roteli-Martins CM, Naud P, De Borba P, Teixeira JC, De Carvalho NS, Zahaf T, et al. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: Up to 8.4 years of follow-up. Hum Vaccin Immunother 2012;8:390-7.
Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, et al. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine 2007;25:4931-9.
Nandakumar A, Ramnath T, Chaturvedi M. The magnitude of cancer cervix in India. Indian J Med Res 2009:219-22.
Dhillon PK, Yeole BB, Dikshit R, Kurkure AP, Bray F. Trends in breast, ovarian and cervical cancer incidence in Mumbai, India over a 30-year period, 1976-2005: An age-period-cohort analysis. Br J Cancer 2011;105:723-30.
Ostor AG. Natural history of cervical intraepithelial neoplasia: A critical review. Int J Gynecol Pathol 1993;12:186-92.
McCredie MR, Sharples KJ, Paul C, Baranyai J, Medley G, Jones RW, et al. Natural history of cervical neoplasia and risk of invasive cancer in women with cervical intraepithelial neoplasia 3: A retrospective cohort study Lancet Oncol 2008;9:425-34.
Castle PE, Stoler MH, Solomon D, Schiffman M. The relationship of community biopsy-diagnosed cervical intraepithelial neoplasia grade 2 to the quality control pathology-reviewed diagnoses: An ALTS report. Am J Clin Pathol 2007;127:805-15.
Castle PE, Schiffman M, Wheeler CM, Solomon D. Evidence for frequent regression of cervical intraepithelial neoplasia-grade 2. Obstet Gynecol 2009;113:18-25.
Villa LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, et al. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. Br J Cancer 2006;95:1459-66.
Harper DM, Williams KB. Prophylactic HPV vaccines: Current knowledge of impact on gynecologic premalignancies. Discov Med 2010;10:7-17.
Barnabas RV, Laukkanen P, Koskela P, Kontula O, Lehtinen M, Garnett GP. Epidemiology of HPV 16 and cervical cancer in Finland and the potential impact of vaccination: Mathematical modeling analyses. PloS Med 2006;3:e138.
Food and Drug Administration Vaccines and Related Biological Products Advisory Committee (VRBPAC) background document: Gardasil HPV Quadrivalent Vaccine. May 18, 2006 VRBPAC Meeting. Available from: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf" [Last accessed on 2013 Apr 27].
Muñoz N, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, et al. Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women. J Natl Cancer Inst 2010;102:325-39.
Beller U, Abu-Rustum NR. Cervical cancers after human papillomavirus vaccination. Obstet Gynecol 2009;113 (2 Pt 2):550-2.
Lawrence G, Gold MS, Hill R, Deeks S, Glasswell A, McIntyre PB. Annual report: Surveillance of adverse events following immunization in Australia, 2007. Commun Dis Intell Q Rep 2008;32:371-87.
National Vaccine Information Center. An Analysis by the National Vaccine Information Center of Gardasil and Menactra Adverse Event Reports to the Vaccine Adverse Events Reporting System (VAERS). February 2009. Available from: http://www. nvic.org/Downloads/NVIC Gardasil vs Menactra VAERS Report Feb-2009u.aspx [Last accessed on 2011 Jan 25].
Menzies R, Mahajan D, Gold MS, Roomiani I, McIntyre P, Lawrence G. Annual report: Surveillance of adverse events following immunization in Australia, 2008. Commun Dis Intell Q Rep 2009;33:365-81.
Mahajan D, Roomiani I, Gold MS, Lawrence GL, McIntyre PB, Menzies RI. Annual report: Surveillance of adverse events following immunization in Australia, 2009. Comm Dis Intell Q Rep 2010;34:259-76.
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;302:750-7.
Medicines and Healthcare products Regulatory Agency (MHRA). Paper provided by MHRA for Joint Committee on Vaccination and Immunisation June 2009: Vaccine associated suspected adverse reactions reported via the Yellow Card scheme during 2008. Available from: http://www.dh.gov.uk/prod_consum_dh/groups/dh_Digital ssets/@dh/@ab/documents/digitalasset/dh_110017.pdf [Last accessed on 2011 Jul 17].
Database of the Netherlands Pharmacovigilance Centre Lareb. Overview adverse events following immunization in association with Cervarix. February 3, 2010. Available from: http://www.lareb.nl/documents/kwb_2010_2_cerva.pdf [Last accessed on 2011 Jul 24].
Irish Medicines Board (IMB). Update on national monitoring experience with Gardasil. 9 th February 2011. Available from: http://www.imb.ie/images/uploaded/documents/IMB_Gardasil_WebUpdate_09Feb2011.pdf [Last accessed on 2011 Jul 17].
Sutton I, Lahoria R, Tan I, Cloustron P, Barnett M. CNS demyelination and quadrivalent HPV vaccination. Mult Scier 2009;15:116-9.
Wildemann B, Jarius S, Hartmann M, Regula JU, Hametner C. Acute disseminated encephalomyelitis following vaccination against human papillomavirus virus. Neurology 2009;72:2132-3.
de Kok IM, van Ballegooijen M, Habbema JD. Cost-effectiveness analysis of human papillomavirus vaccination in the Netherlands. J Natl Cancer Inst 2009;101:1083-92.
Ginsberg GM, Edejer TT, Lauer JA, Sepulveda C. Screening, prevention and treatment of cervical cancer: A global and regional generalized cost-effectiveness analysis. Vaccine 2009;27:6060-79.
Shastri SS, Mittra I, Mishra G, Gupta S, Dikshit R, Badwe RA. Effect of visual inspection with acetic acid (VIA) screening by primary health workers on cervical cancer mortality: A cluster randomized controlled trial in Mumbai, India. Program and abstracts of the 2013 American Society of Clinical Oncology Annual Meeting. Chicago: May 31-June 4, 2013.

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[1] de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, et al. Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: A retrospective cross-sectional worldwide study. Lancet Oncol 2010;11:1048-56.

[2] Gillison ML, Chaturvedi AK, Lowy DR. HPV prophylactic vaccines and the potential prevention of noncervical cancers in both men and women. Cancer 2008;113 (10 Suppl):3036-46.

[3] Garland SM, Steben M, Sings HL, James M, Lu S, Railkar R, et al. Natural history of genital warts: Analysis of the placebo arm of 2 randomized phase III trials of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine. J Infect Dis 2009;199:805-14.

[4] Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, et al. Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med 2007;356:1928-43.

[5] FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007;356:1915-27.

[6] Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeron J, Wheeler CM, et al. HPV PATRICIA study group. 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, randomized controlled trial. Lancet 2007;369:2161-70.

[7] Herrero R, Hildesheim A, Rodriguez AC, Wacholder S, Bratti C, Solomon D, et al. Costa Rica Vaccine Trial (CVT) Group. Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica. Vaccine 2008;26:4795-808.

[8] Castellsague X, Munoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K, et al. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. Br J Cancer 2011;105:28-37.

[9] Lehtinen M, Paavonen J, Wheeler CM, Jaisamrarn U, Garland SM, Castellsague X, et al. HPV PATRICIA Study Group. 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 randomized, double-blind PATRICIA trial. Lancet Oncol 2012;13:89-99.

[10] Wheeler CM, Castellsague X, Garland SM, Szarewski A, Paavonen J, Naud P, et al. HPV PATRICIA Study Group. 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 randomized, double-blind PATRICIA trial. Lancet Oncol 2012;13:100-10.

[11] Kjaer SK, Frederiksen K, Munk C, Iftner T. Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: Role of persistence. J Natl Cancer Inst 2010;102:1478-88.

[12] Roteli-Martins CM, Naud P, De Borba P, Teixeira JC, De Carvalho NS, Zahaf T, et al. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: Up to 8.4 years of follow-up. Hum Vaccin Immunother 2012;8:390-7.

[13] Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, et al. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine 2007;25:4931-9.

[14] Nandakumar A, Ramnath T, Chaturvedi M. The magnitude of cancer cervix in India. Indian J Med Res 2009:219-22.

[15] Dhillon PK, Yeole BB, Dikshit R, Kurkure AP, Bray F. Trends in breast, ovarian and cervical cancer incidence in Mumbai, India over a 30-year period, 1976-2005: An age-period-cohort analysis. Br J Cancer 2011;105:723-30.

[16] Ostor AG. Natural history of cervical intraepithelial neoplasia: A critical review. Int J Gynecol Pathol 1993;12:186-92.

[17] McCredie MR, Sharples KJ, Paul C, Baranyai J, Medley G, Jones RW, et al. Natural history of cervical neoplasia and risk of invasive cancer in women with cervical intraepithelial neoplasia 3: A retrospective cohort study Lancet Oncol 2008;9:425-34.

[18] Castle PE, Stoler MH, Solomon D, Schiffman M. The relationship of community biopsy-diagnosed cervical intraepithelial neoplasia grade 2 to the quality control pathology-reviewed diagnoses: An ALTS report. Am J Clin Pathol 2007;127:805-15.

[19] Castle PE, Schiffman M, Wheeler CM, Solomon D. Evidence for frequent regression of cervical intraepithelial neoplasia-grade 2. Obstet Gynecol 2009;113:18-25.

[20] Villa LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, et al. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. Br J Cancer 2006;95:1459-66.

[21] Harper DM, Williams KB. Prophylactic HPV vaccines: Current knowledge of impact on gynecologic premalignancies. Discov Med 2010;10:7-17.

[22] Barnabas RV, Laukkanen P, Koskela P, Kontula O, Lehtinen M, Garnett GP. Epidemiology of HPV 16 and cervical cancer in Finland and the potential impact of vaccination: Mathematical modeling analyses. PloS Med 2006;3:e138.

[23] Food and Drug Administration Vaccines and Related Biological Products Advisory Committee (VRBPAC) background document: Gardasil HPV Quadrivalent Vaccine. May 18, 2006 VRBPAC Meeting. Available from: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf" [Last accessed on 2013 Apr 27].

[24] Muñoz N, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, et al. Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women. J Natl Cancer Inst 2010;102:325-39.

[25] Beller U, Abu-Rustum NR. Cervical cancers after human papillomavirus vaccination. Obstet Gynecol 2009;113 (2 Pt 2):550-2.

[26] Lawrence G, Gold MS, Hill R, Deeks S, Glasswell A, McIntyre PB. Annual report: Surveillance of adverse events following immunization in Australia, 2007. Commun Dis Intell Q Rep 2008;32:371-87.

[27] National Vaccine Information Center. An Analysis by the National Vaccine Information Center of Gardasil and Menactra Adverse Event Reports to the Vaccine Adverse Events Reporting System (VAERS). February 2009. Available from: http://www. nvic.org/Downloads/NVIC Gardasil vs Menactra VAERS Report Feb-2009u.aspx [Last accessed on 2011 Jan 25].

[28] Menzies R, Mahajan D, Gold MS, Roomiani I, McIntyre P, Lawrence G. Annual report: Surveillance of adverse events following immunization in Australia, 2008. Commun Dis Intell Q Rep 2009;33:365-81.

[29] Mahajan D, Roomiani I, Gold MS, Lawrence GL, McIntyre PB, Menzies RI. Annual report: Surveillance of adverse events following immunization in Australia, 2009. Comm Dis Intell Q Rep 2010;34:259-76.

[30] 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;302:750-7.

[31] Medicines and Healthcare products Regulatory Agency (MHRA). Paper provided by MHRA for Joint Committee on Vaccination and Immunisation June 2009: Vaccine associated suspected adverse reactions reported via the Yellow Card scheme during 2008. Available from: http://www.dh.gov.uk/prod_consum_dh/groups/dh_Digital ssets/@dh/@ab/documents/digitalasset/dh_110017.pdf [Last accessed on 2011 Jul 17].

[32] Database of the Netherlands Pharmacovigilance Centre Lareb. Overview adverse events following immunization in association with Cervarix. February 3, 2010. Available from: http://www.lareb.nl/documents/kwb_2010_2_cerva.pdf [Last accessed on 2011 Jul 24].

[33] Irish Medicines Board (IMB). Update on national monitoring experience with Gardasil. 9 th February 2011. Available from: http://www.imb.ie/images/uploaded/documents/IMB_Gardasil_WebUpdate_09Feb2011.pdf [Last accessed on 2011 Jul 17].

[34] Sutton I, Lahoria R, Tan I, Cloustron P, Barnett M. CNS demyelination and quadrivalent HPV vaccination. Mult Scier 2009;15:116-9.

[35] Wildemann B, Jarius S, Hartmann M, Regula JU, Hametner C. Acute disseminated encephalomyelitis following vaccination against human papillomavirus virus. Neurology 2009;72:2132-3.

[36] de Kok IM, van Ballegooijen M, Habbema JD. Cost-effectiveness analysis of human papillomavirus vaccination in the Netherlands. J Natl Cancer Inst 2009;101:1083-92.

[37] Ginsberg GM, Edejer TT, Lauer JA, Sepulveda C. Screening, prevention and treatment of cervical cancer: A global and regional generalized cost-effectiveness analysis. Vaccine 2009;27:6060-79.

[38] Shastri SS, Mittra I, Mishra G, Gupta S, Dikshit R, Badwe RA. Effect of visual inspection with acetic acid (VIA) screening by primary health workers on cervical cancer mortality: A cluster randomized controlled trial in Mumbai, India. Program and abstracts of the 2013 American Society of Clinical Oncology Annual Meeting. Chicago: May 31-June 4, 2013.

Is human papillomavirus vaccination likely to be a useful strategy in India?

Abstract

Abstract

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References

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