Scientific evidence supporting recommendations on the use of the 9-valent HPV vaccine in a 2-dose vaccine schedule in Australia

Authors

  • Peter Wnukowski-Mtonga Research Officer, National Centre for Immunisation Research and Surveillance, Westmead, New South Wales
  • Sanjay Jayasinghe Research Fellow, National Centre for Immunisation Research and Surveillance and Discipline of Child and Adolescent Health, The Children’s Hospital at Westmead Clinical School, University of Sydney, Sydney, New South Wales
  • Clayton Chiu Public Health Physician, National Centre for Immunisation Research and Surveillance and Discipline of Child and Adolescent Health, The Children’s Hospital at Westmead Clinical School, University of Sydney, Sydney, New South Wales
  • Kristine Macartney Director, National Centre for Immunisation Research and Surveillance and Discipline of Child and Adolescent Health, The Children’s Hospital at Westmead Clinical School, University of Sydney, Sydney, New South Wales
  • Julia Brotherton Public Health Physician and Medical Director, Victorian Cytology Service Population Health, VCS Foundation and School of Population and Global Health, University of Melbourne, Melbourne, Victoria
  • Basil Donovan Sexual Health and Public Health Physician, The Kirby Institute, University of New South Wales and Sydney Sexual Health Centre, Sydney Hospital, Sydney, New South Wales
  • Madeline Hall Nurse Practitioner, Royal Brisbane and Women’s Hospital, Queensland Health, Brisbane, Queensland
  • David W Smith Clinical Virologist, Department of Microbiology, PathWest Laboratory Medicine WA and Faculty of Health and Medical Sciences, University of Western Australia, Nedlands, Western Australia
  • Karen Peterson Manager, Immunisation Program, Queensland Health, Brisbane, Queensland
  • Sue Campbell-Lloyd Manager, Immunisation Unit, Communicable Diseases Branch, Health Protection NSW, NSW Health, Sydney, New South Wales
  • Christine Selvey Medical Epidemiologist, Communicable Diseases Branch, Health Protection NSW, NSW Health, Sydney, New South Wales
  • Michelle Giles Infectious Diseases Physician, The Alfred Hospital and Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria
  • John Kaldor Senior Principal Research Fellow, The Kirby Institute, University of New South Wales, Sydney, New South Wales
  • Helen Marshall Senior Medical Practitioner and Director, Vaccinology and Immunology Research Trials Unit, Women’s and Children’s Hospital and Robinson Research Institute and Adelaide Medical School, University of Adelaide, North Adelaide, South Australia

DOI:

https://doi.org/10.33321/cdi.2020.44.33

Keywords:

Human papilloma virus, HPV vaccine, Cervical cancer, Vaccine schedule, genital warts

Abstract

The Australian Technical Advisory Group on Immunisation (ATAGI) updated recommendations on the use of human papillomavirus (HPV) vaccines in the Australian Immunisation Handbook in 2018, regarding the use of the recently available 9-valent (9vHPV) vaccine, Gardasil 9, and a 2-dose schedule for young adolescents for HPV vaccines. This report provides an overview of the relevant scientific evidence that underpinned these updated recommendations. The 9vHPV vaccine includes 5 HPV types (HPV 31, 33, 45, 52 and 58) additional to the 4 that are also covered by the 4vHPV (Gardasil) vaccine (HPV 6,11,16,18). Accordingly, the 9vHPV vaccine is expected to prevent an additional 15% of cervical cancers and up to 20% of other HPV-related cancers. Non-inferior antibody responses after two 9vHPV vaccine doses given 6–12 months apart in girls and boys aged 9–14 years compared to women aged 16–26 years after three doses support the 2-dose schedule for adolescents of this age group. In clinical trials 9vHPV vaccine was well-tolerated with a similar safety profile to 4vHPV vaccine. The switch to 9vHPV vaccine and a 2-dose schedule is anticipated to improve public acceptability of the program and reduce HPV-related disease in the long-term.

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References

Chesson HW, Dunne EF, Hariri S, Markowitz LE. The estimated lifetime probability of acquiring human papillomavirus in the United States. Sex Transm Dis. 2014;41(11):660–4.

Brotherton JM, Condon JR, McIntyre PB, Tabrizi SN, Malloy M, Garland SM. Human papillomavirus prevalence to age 60 years among Australian women prevaccination. Sex Health. 2015;12(4):353–9.

Vajdic CM, van Leeuwen MT, Jin F, Prestage G, Medley G, Hillman RJ et al. Anal human papillomavirus genotype diversity and co-infection in a community-based sample of homosexual men. Sex Transm Infect. 2009;85(5):330–5.

Brotherton JML, Tabrizi SN, Phillips S, Pyman J, Cornall AM, Lambie N et al. Looking beyond human papillomavirus (HPV) genotype 16 and 18: defining HPV genotype distribution in cervical cancers in Australia prior to vaccination Int J Cancer. 2017;141(8):1576–84.

Hillman RJ, Garland SM, Gunathilake MP, Stevens M, Kumaradevan N, Lemech C et al. Human papillomavirus (HPV) genotypes in an Australian sample of anal cancers. Int J Cancer. 2014;135(4):996–1001.

Antonsson A, Wilson LF, Kendall BJ, Bain CJ, Whiteman DC, Neale RE. Cancers in Australia in 2010 attributable to infectious agents. Aust N Z J Public Health. 2015;39(5):446–51.

Grulich AE, Jin F, Conway EL, Stein AN, Hocking J. Cancers attributable to human papillomavirus infection. Sex Health. 2010;7(3):244–52.

Patel C, Brotherton JM, Pillsbury A, Jayasinghe S, Donovan B, Macartney K et al. The impact of 10 years of human papillomavirus (HPV) vaccination in Australia: what additional disease burden will a nonavalent vaccine prevent? Euro Surveill. 2018;23(41). https://doi.org/10.2807/1560-7917.ES.2018.23.41.1700737.

Australian Institute of Health and Welfare (AIHW). Cervical screening in Australia 2014–2015. Cancer series no. 105. Cat. no. CAN 104. Canberra: Australian Government, AIHW; 2017. [Accessed: 5 July 2017.] Available from: http://www.aihw.gov.au/publication-detail/?id=60129559631 .

Jin F, Stein AN, Conway EL, Regan DG, Law M, Brotherton JM et al. Trends in anal cancer in Australia, 1982–2005. Vaccine. 2011;29(12):2322–7.

Hocking JS, Stein A, Conway EL, Regan D, Grulich A, Law M et al. Head and neck cancer in Australia between 1982 and 2005 show increasing incidence of potentially HPV-associated oropharyngeal cancers. Br J Cancer. 2011;104(5):886–91.

Grulich AE, De Visser RO, Smith AM, Rissel CE, Richters J. Sexually transmissible infection and blood-borne virus history in a representative sample of adults. Aust N Z J Public Health. 2003;27(2):234–41.

Pirotta M, Stein AN, Conway EL, Harrison C, Britt H, Garland S. Genital warts incidence and healthcare resource utilisation in Australia. Sex Transm Infect. 2010;86(3):181–6.

Tabrizi SN, Brotherton JM, Kaldor JM, Skinner SR, Liu B, Bateson D et al. Assessment of herd immunity and cross protection after a human papillomavirus vaccination programme in Australia: a repeat cross sectional study. Lancet Infect Dis. 2014;14(10):958–66.

Brotherton JM, Fridman M, May CL, Chappell G, Saville AM, Gertig DM. Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study. Lancet. 2011;377(9783):2085–92.

Brotherton JM, Gertig DM, May C, Chappell G, Saville M. HPV vaccine impact in Australian women: ready for an HPV-based screening program. Med J Aust. 2016;204(5):184–184e1.

Gertig DM, Brotherton JM, Budd AC, Drennan K, Chappell G, Saville AM. Impact of a population-based HPV vaccination program on cervical abnormalities: a data linkage study. BMC Med. 2013;11:227.

Ali H, Donovan B, Wand H, Read TR, Regan DG, Grulich AE et al. Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. BMJ. 2013;346:f2032.

Cancer Council Australia Cervical Cancer Screening Guidelines Working Party. National Cervical Screening Program: Guidelines for the management of screen-detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding. [Internet.] Cancer Council Australia; 2017. [Accessed: 10 September 2018.] Available from: https://wiki.cancer.org.au/australia/Guidelines:Cervical_cancer/Screening

World Health Organisation. Human papillomavirus vaccines: WHO position paper, October 2014. Wkly Epidemiol Rec. 2014;89(43):465–91.

World Health Organisation. Human papillomavirus vaccines: WHO position paper, May 2017. Wkly Epidemiol Rec. 2017;92(19):241–68.

World Health Organisation. Meeting of the Strategic Advisory Group of Experts on immunization, April 2014 – conclusions and recommendations. 2014. Wkly Epidemiol Rec. 2014;89(21):221–236.

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.

Iversen OE, Miranda MJ, Ulied A, Soerdal T, Lazarus E, Chokephaibulkit K et al. Immunogenicity of the 9-valent HPV vaccine using 2-dose regimens in girls and boys vs a 3-dose regimen in women. JAMA. 2016;316(22):2411–21.

Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M et al. Immunogenicity of 2 doses of HPV Vaccine in younger adolescents vs 3 doses in young women. JAMA. 2013;309(17):1793–802.

Ogilvie G, Sauvageau C, Dionne M, McNeil S, Krajden M, Money D et al. Immunogenicity of 2 vs 3 doses of the quadrivalent human papillomavirus vaccine in girls aged 9 to 13 years after 60 months. JAMA. 2017;317(16):1687–8.

Sankaranarayanan R, Prabhu PR, Pawlita M, Gheit T, Bhatla N, Muwonge R et al. Immunogenicity and HPV infection after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre prospective cohort study. Lancet Oncol. 2016;17(1):67–77.

Blomberg M, Dehlendorff C, Sand C, Kjaer SK. Dose-related differences in effectiveness of human papillomavirus vaccination against genital warts: a nationwide study of 550,000 young girls. Clin Infect Dis. 2015;61(5):676–82.

Puthanakit T, Huang LM, Chiu CH, Tang RB, Schwarz TF, Esposito S et al. Randomized open trial comparing 2-dose regimens of the HPV-16/18 AS04-adjuvanted vaccine in girls aged 9–14 years versus 3 doses in women aged 15–25 years. J Infect Dis. 2016;214(4):525–36.

GlaxoSmithKline Vaccine HPV-007 Study Group, Romanowski B, de Borba P, Naud P, Roteli-Martins CM, De Carvalho NS et al. Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6·4 years. Lancet. 2009;374(9706):1975–85.

Romanowski B, Schwarz TF, Ferguson L, Peters K, Dionne M, Behre U et al. Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a two-dose schedule in adolescent girls: Five-year clinical data and modeling predictions from a randomized study. Hum Vaccin Immunother. 2016;12(1):20–9.

Romanowski B, Schwarz TF, Ferguson LM, Ferguson M, Peters K, Dionne M et al. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: results from a randomized study. Hum Vaccin Immunother. 2014;10(5):1155–65.

Romanowski B, Schwarz TF, Ferguson LM, Peters K, Dionne M, Schulze K et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study. Hum Vaccin. 2011;7(12):1374–86.

Kreimer AR, González P, Katki HA, Porras C, Schiffman M, Rodriguez AC et al. Efficacy of a bivalent HPV 16/18 vaccine against anal HPV 16/18 infection among young women: a nested analysis within the Costa Rica Vaccine Trial. Lancet Oncol. 2011;12(9):862–70.

Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014;58(3):309–18.

Guevara A, Cabello R, Woelber L, Moreira ED, Joura E, Reich O, Shields C, Ellison MC, Joshi A, Luxembourg A. Antibody persistence and evidence of immune memory at 5years following administration of the 9-valent HPV vaccine. Vaccine. 2017;35(37):5050–7.

Ferris DG, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Mehlsen J et al. 4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents after 10 years. Pediatrics. 2017;140(6). pii: e20163947.

Macartney KK, Chiu C, Georgousakis M, Brotherton JM. Safety of human papillomavirus vaccines: a review. Drug Saf. 2013;36(6) 393–412.

Phillips A, Patel C, Pillsbury A, Brotherton J, Macartney K. Safety of human papillomavirus vaccines: an updated review. Drug Saf. 2018;41(4):329–46.

Moreira ED Jr, Palefsky JM, Giuliano AR, Goldstone S, Aranda C, Jessen H et al. Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Hum Vaccin. 2011;7(7):768–75.

Kosalaraksa P, Mehlsen J, Vesikari T, Forstén 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.

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.

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Published

15/04/20

How to Cite

Wnukowski-Mtonga, Peter, Sanjay Jayasinghe, Clayton Chiu, Kristine Macartney, Julia Brotherton, Basil Donovan, Madeline Hall, et al. 2020. “Scientific Evidence Supporting Recommendations on the Use of the 9-Valent HPV Vaccine in a 2-Dose Vaccine Schedule in Australia”. Communicable Diseases Intelligence 44 (April). https://doi.org/10.33321/cdi.2020.44.33.

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Vol. 44 (2020)

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