Fixed sized samples for type-specific surveillance of human papillomavirus in genital warts
Edward K. Waters A D , Andrew J. Hamilton B , Anthony M. A. Smith C , David J. Philp A , Basil Donovan A and David G. Regan AA The Kirby Institute, the University of New South Wales, Sydney, NSW 2052, Australia.
B Melbourne School of Land and Environment, The University of Melbourne, Dookie College, Dookie, Vic. 3647, Australia.
C Australian Research Centre in Sex, Health and Society, La Trobe University, Melbourne, Vic. 3000, Australia.
D Corresponding author. Email: ewaters@kirby.unsw.edu.au
Sexual Health 10(1) 95-96 https://doi.org/10.1071/SH12056
Submitted: 19 January 2012 Accepted: 4 June 2012 Published: 19 November 2012
Abstract
Surveillance data suggest that human papillomavirus (HPV) vaccination in Australia is reducing the incidence of genital warts. However, existing surveillance measures do not assess the proportion of the remaining cases of warts that are caused by HPV types other than 6 or 11, against which the vaccine has no demonstrated effectiveness. Using computer simulation rather than sample size formulae, we established that genotyping at least 60 warts can accurately test whether the proportion of warts due to HPV types not targeted by the vaccine has increased (Type I error probability ≤0.05, Type II error probability <0.07). Standard formulae for calculating sample size, in contrast, suggest that a sample size of more than 130 would be required for this task, but using these formulae entails making several strong assumptions. Our methods require fewer assumptions and demonstrate that a smaller sample size than anticipated could be used to address the question of what proportion of post-vaccination cases of warts are due to nonvaccine types. In conjunction with indications of incidence and prevalence provided by existing surveillance measures, this could indicate the number of cases of post-vaccination warts due to nonvaccine types and hence whether type replacement is occurring.
Additional keywords: computer simulation, Gardasil, quadrivalent, surveillance, vaccination.
References
[1] Read TRH, Hocking JS, Chen MY, Donovan B, Bradshaw CS, Fairley CK. The near disappearance of genital warts in young women 4 years after commencing a national human papillomavirus (HPV) vaccination programme. Sex Transm Infect 2011; 87 544–7.| The near disappearance of genital warts in young women 4 years after commencing a national human papillomavirus (HPV) vaccination programme.Crossref | GoogleScholarGoogle Scholar |
[2] Fairley CK, Hocking JS, Gurrin LC, Chen MY, Donovan B, Bradshaw CS. Rapid decline in presentations of genital warts after the implementation of a national quadrivalent human papillomavirus vaccination programme for young women. Sex Transm Infect 2009; 85 499–502.
| Rapid decline in presentations of genital warts after the implementation of a national quadrivalent human papillomavirus vaccination programme for young women.Crossref | GoogleScholarGoogle Scholar | 1:STN:280:DC%2BD1MjotVGrtg%3D%3D&md5=ae31a9b0b5ce58d520dcb37ebd8237d5CAS | 19837728PubMed |
[3] Donovan B, Franklin N, Guy R, Grulich AE, Regan DG, Ali H, et al Quadrivalent human papillomavirus vaccination and trends in genital warts in Australia: analysis of national sentinel surveillance data. Lancet Infect Dis 2011; 11 39–44.
| Quadrivalent human papillomavirus vaccination and trends in genital warts in Australia: analysis of national sentinel surveillance data.Crossref | GoogleScholarGoogle Scholar | 21067976PubMed |
[4] The FUTURE I/II Study Group. Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial. BMJ 2010; 341 c3493
| Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial.Crossref | GoogleScholarGoogle Scholar | 20647284PubMed |
[5] Villa LL, Costa RLR, Petta CA, Andrade RP, Paavonen J, Iversen O-E, 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.
| 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.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BD28Xht1Cntr3L&md5=63f575eaebbcfbaccdb77cecdf710520CAS | 17117182PubMed |
[6] 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.
| 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.Crossref | GoogleScholarGoogle Scholar | 19199546PubMed |
[7] Brown DR, Schroeder JM, Bryan JT, Stoler MH, Fife KH. Detection of multiple human papillomavirus types in Condylomata acuminata lesions from otherwise healthy and immunosuppressed patients. J Clin Microbiol 1999; 37 3316–22.
| 1:STN:280:DyaK1MvhvFWlsg%3D%3D&md5=a8649418a6216d0fd7bf4631a8ed9a18CAS | 10488198PubMed |
[8] Grce M, Husnjak K, Skerlev M, Lipozencic J, Pavelic K. Detection and typing of human papillomaviruses by means of polymerase chain reaction and fragment lenth polymorphism in male genital lesions. Anticancer Res 2000; 20 2097–102.
| 1:CAS:528:DC%2BD3cXlvFCqsrw%3D&md5=1fd9c4cfd55990e408ebaa5231282fb2CAS | 10928159PubMed |
[9] Müller EE, Chirwa TF, Lewis DA. Human papillomavirus (HPV) infection in heterosexual South African men attending sexual health services: associations between HPV and HIV serostatus. Sex Transm Infect 2010; 86 175–80.
| Human papillomavirus (HPV) infection in heterosexual South African men attending sexual health services: associations between HPV and HIV serostatus.Crossref | GoogleScholarGoogle Scholar | 19880970PubMed |
[10] Potocnik M, Kocjan B, Seme K, Poljak M. Distribution of human papillomavirus (HPV) genotypes in genital warts from males in Slovenia. Acta Dermatovenerol Alp Panonica Adriat 2007; 16 91–6.
| 1:STN:280:DC%2BD2snns12ksA%3D%3D&md5=3cd56d63b2b20126c523a5edb53533e1CAS | 17994168PubMed |
[11] Chan PKS, Luk ACS, Luk TNM, Lee K-F, Cheung JLK, Ho K-M, et al Distribution of human papillomavirus types in anogenital warts of men. J Clin Virol 2009; 44 111–4.
| Distribution of human papillomavirus types in anogenital warts of men.Crossref | GoogleScholarGoogle Scholar | 1:CAS:528:DC%2BD1MXhsFKntr4%3D&md5=13f0c62c5ccf78eeed28056183db732dCAS |
[12] Hamilton AJ, Waters EK, Kim HJ, Pak WS, Furlong MJ. Validation of fixed sample-size plans for monitoring lepidopteran pests of Brassica oleracea crops in North Korea. J Econ Entomol 2009; 102 1336–46.
| Validation of fixed sample-size plans for monitoring lepidopteran pests of Brassica oleracea crops in North Korea.Crossref | GoogleScholarGoogle Scholar | 1:STN:280:DC%2BD1MvptlKitQ%3D%3D&md5=ff21a890327274b8f60390fb9ab036b5CAS | 19610455PubMed |
[13] Cochran WG. Sampling techniques. Second edition. New York: J Wiley & Sons; 1963.
