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HPV vaccine for teenagers Dr Sally Ferguson with thanks to MSD. . for most HPV vaccine for teenagers Dr Sally Ferguson with thanks to MSD. . for most of the slides 1

What is HPV? v. HPV is a common virus (the human papillomavirus) v. Some What is HPV? v. HPV is a common virus (the human papillomavirus) v. Some HPV types can cause genital warts v. Other types can infect a woman’s cervix and lead to cervical cancer over many years 2

The Problem: • Lifetime risk of genital /cervical HPV 1 in 2 • Lifetime The Problem: • Lifetime risk of genital /cervical HPV 1 in 2 • Lifetime risk of HGSIL is 1 in 25 • Lifetime risk of Cervical cancer is 1 in 31 (no pap smears done) • Lifetime risk of Cervical cancer 1 in 125 (having pap smears) • Lifetime risk of genital warts 1 in 8 3

Natural history of HPV infection to Cervical cancer 0– 1 yrs 0– 5 yrs Natural history of HPV infection to Cervical cancer 0– 1 yrs 0– 5 yrs Persistent infection 1– 20 yrs High Grade Precancers (CIN 2/3) HPV infection Low Grade Precancers (CIN 1) Cervical Cancer Recovery: HPV clearance… 90% Pinto AP, Crum CP. Clin Obstet Gynecol. 2000; 43: 352– 362. 4

HPV related diseases in Male and Female cancers: • • Cervix 100% Vulva 40% HPV related diseases in Male and Female cancers: • • Cervix 100% Vulva 40% Vagina 40% Anus 90% Oro-pharynx 12% Other illnesses RRP (larynx wart in children) 100% • Genital Wart 100% Parkin DM Lacey CJN Vaccine 2006 S 3/17 35 HPV Attributable % Male Cancers l Anus l Penis l Oro-pharynx l Other illnesses l RRP l Genital Wart 90% 40% 12% 100% 5

HK Cervical Cancer (1996 -2010) 10 th among female cancers Lifetime risk: 1 in HK Cervical Cancer (1996 -2010) 10 th among female cancers Lifetime risk: 1 in 145 New Case 400 (2010) Death 146 (2010) Report of Hong Kong Cancer Registry HA 2010 http: //www 3. ha. org. hk/cancereg/ Crude rate: 10. 7 per 100, 000 6

Genital warts are common in Hong Kong New cases per year: Genital Warts = Genital warts are common in Hong Kong New cases per year: Genital Warts = 11, 524 204 cases per 100, 000 adults Lin C BMC Infect Dis. 2010 Sep 17 10 272 7

子宮頸癌的預防方法 8 子宮頸癌的預防方法 8

99. 7% Cervical cancers are associated with HPV 9 99. 7% Cervical cancers are associated with HPV 9

HPV Vaccine technology • Empty Shell formed by recombinant biotechnology to mimic the viral HPV Vaccine technology • Empty Shell formed by recombinant biotechnology to mimic the viral 3 D shape. • Does not contain infectious DNA。 Vaccine Real Virus • Does not contain mercury (thimerosal) GARDASIL is a trademark of Merck & Co. , Inc. , Whitehouse Station, NJ, USA. *VLP = Virus-like particle. 1. Villa LL, Costa RL, Petta CA, et al. Lancet Oncol. 2005; 6: 271– 278. 10 Image courtesy of Dr. Ian Frazer

Dosing schedule GARDASIL Intramuscular injection (IM) Recommended schedule 3 doses at month 0, 2, Dosing schedule GARDASIL Intramuscular injection (IM) Recommended schedule 3 doses at month 0, 2, 6 month Completed within 1 year will be considered as per-protocol CERVARIX Vaccine: 3 doses at month 0, 1, 6 11

4 in 1 vaccine: 9 years Long Term follow-up 9 years Antibody report 8 4 in 1 vaccine: 9 years Long Term follow-up 9 years Antibody report 8 years Efficacy report Gardasil: No breakthrough case up to 8 years 12 Nygård M IPC 2012 Nov 30 – Dec 6, Puerto Rico, EP-741

How long is the duration of protection? Is booster dose needed? US CDC 2012 How long is the duration of protection? Is booster dose needed? US CDC 2012 Feb: Gardasil vaccine information statement • Protection from HPV vaccine is expected to be long-lasting • Additional (booster) doses are not recommended. http: //www. cdc. gov/vaccines/pubs/vis/downloads/vis-hpv-gardasil. pdf 13

All women are at risk of HPV infection All HPV * Chan et al. All women are at risk of HPV infection All HPV * Chan et al. Determinants of cervical human papillomavirus infection: differences between high and low oncogenic risk types. J Infect Dis 2002; 185: 28 -35. High risk HPV Low risk HPV 14

Gardasil / Silgard Approvals GARDASIL approved in 127 countries (includes 24 GAVI-eligible) Europe: Caribbean Gardasil / Silgard Approvals GARDASIL approved in 127 countries (includes 24 GAVI-eligible) Europe: Caribbean & Central America: North America: Costa Rica Puerto Rico Guatemala Curaçao Bermuda Bahamas Barbados Jamaica Trinidad/Tobago El Salvador Honduras Nicaragua Panama Cayman Islands Aruba Dominican Republic South America: Brazil Argentina Peru Colombia Paraguay Bolivia Uruguay Ecuador Chile USA Canada Mexico 42 3 16 9 Middle East & Africa: Gabon Israel Morocco Kenya Mauritania Guinea Eq. Uganda Malawi Jordan Cote d’Ivoire Chad Lebanon South Africa Pakistan Guinea Conakry Namibia C. A. R. Mauritius Kuwait UAE Ethiopia Togo Congo Brazzaville Egypt Burkina Faso Bahrain Tanzania Cameroon Tunisia Saudi Arabia Botswana Zambia Nigeria Mali Rwanda Germany France UK Spain Italy Austria Belgium Bulgaria Portugal Slovenia Montenegro Bosnia Croatia Herzogovina 35 Cyprus Czech Republic Denmark Estonia Finland Greece Hungary Iceland Romania Sweden Switzerland Russia Turkey Macedonia 22 Ireland Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Slovakia Serbia Liechtenstein Belarus Ukraine Albania Asia Pacific & Japan: Kyrgyzstan Uzbekistan Kazakhstan Australia Indonesia Korea Taiwan Hong Kong Singapore New Zealand Macau Malaysia Philippines Thailand India Vietnam Fiji Bhutan Georgia JAPAN Sri Lanka Brunei GAVI – Eligible Registration Approvals (24): Burkina Faso, Cameroon, Central African Republic, Chad, Congo (DR), Cote d’Ivoire, Ethiopia, Guinea (Conakry), India, Kenya, Kyrgyzstan, Malawi, Mali, Mauritania, Nicaragua, Nigeria, Pakistan, Rwanda, Tanzania, Togo, Uganda, Uzbekistan, Vietnam, Zambia

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Routine immunization of Male with Gardasil in US and Australia ( and Canada) US: Routine immunization of Male with Gardasil in US and Australia ( and Canada) US: 11 - 21 Male Australia: 12 - 13 Male Accessed 26 Oct 2011 http: //www. cdc. gov/media/releases/2011/a 1025_ACIP_HPV_Vote. html http: //www. merck. com/newsroom/news-release-archive/vaccine-news/2011_1025. html http: //www. pbs. gov. au/industry/listing/elements/pbac-meetings/pbac-outcomes/ 17

The near disappearance of genital warts in young women 4 years after Gardasil program The near disappearance of genital warts in young women 4 years after Gardasil program in Australia Female <21: ↓ 90% Male <21: ↓ 87% 18 Read TR Sex Transm Infect. 2011 Oct 4

Trend of genital warts after universal HPV vaccination 2 in 1 HPV vaccine UK Trend of genital warts after universal HPV vaccination 2 in 1 HPV vaccine UK UK Health Protection Agency Report 2010 4 in 1 HPV vaccine Australia Read TR Sex Transm Infect. 2011 Oct 4 19 Data are NOT generated from head-to-head study and results are NOT directly comparable because of differences in the methodologies and analysis populations.

HPV vaccine is for men and women To prevent vaccine type related Female: Cervical HPV vaccine is for men and women To prevent vaccine type related Female: Cervical 、vaginal、vulvar Cancers and genital warts Male: genital warts + 4 -in-1 HPV vaccination Regular Pap screening 20