HPV vaccination Where are we now? Where are we going? Margaret Stanley Department of Pathology Cambridge

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1 HPV vaccination Where are we now? Where are we going? Margaret Stanley Department of Pathology Cambridge 1

2 Disclosure Statement Dr. Margaret Stanley has acted as a consultant and advisor for Merck Sharp & Dohme, GlaxoSmithKline, and Sanofi Pasteur Merck Sharp & Dohme.

3 HPV Non enveloped dsdna virus, simple capsid of 2 proteins L1 and L2 Common virus with >100 types identified Infects cutaneous and mucosal epithelia infect the mucosal epithelia of women and men 2 groups low risk types causing warts HPV 6,11 13 high risk types causing cancer 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59,68 HPV 16,18 most important 3

4 Worldwide HPV-Related Disease Burden: 607,000 Cancer Cases in Men and Women Penile cancer 1 11,000 Male Female 21,000 Vulvar & vaginal cancer 1 Oropharyngeal cancer 1 17,000 4,400 Oropharyngeal cancer 1 Anal cancer 1 11,000 13,000 Anal cancer 1 530,000 Cervical cancer 1 x 60 fold 9,000,000 High-grade cervical dysplasia 2,3, * 21,900,000 Low-grade cervical dysplasia 2,3, Genital warts 4,5, Genital warts 4,5, 17,300,000 14,700,000 *Estimated 90% of high-grade cervical lesions are HPV related 3 ; Estimated 73% of low-grade cervical lesions are HPV related 3 ; Estimated gender ratio of genital warts: 54% males; 46% females 6 1. Forman D, et al. Vaccine. 2012;30:F12-F23; 2. World Health Organization; 3. Guan P, et al. Int J Cancer. 2012;131: ; 4. World Health Organization; 5. Greer CE, et al. J Clin Microbiol. 1995;33: ; 6. Public Health England. 4

5 % among HPV positive cases RELATIVE CONTRIBUTION of HPV 16,18,45,31,33,52,58,35 & 6 100% CERVIX VULVA VAGINA PENIS ANUS OROPHARYNX 80% 60% 40% 20% 0% HPV16 HPV18 HPV45 HPV31 HPV33 HPV52 HPV58 HPV35 HPV6 The 8 most common HPV types in CaCx De Sanjose et al 2010 Lancet Oncol. 2010;11:

6 Prophylactic HPV VLP Vaccine Profiles Cervarix Bivalent vaccine Gardasil Quadrivalent vaccine Gardasil9 Nonavalent vaccine Manufacturer Glaxo Smith Kline Merck Merck Volume Per dose 0.5ml Per dose 0.5ml Per dose 0.5ml Adjuvant ASO4: Al(OH) 3 MPL 500mg 50mg Amorphous Aluminium Hydroxyphosphate sulphate 225mg Amorphous Aluminium 500mg Hydroxyphosphate sulphate Antigens L1 HPV16 20µg L1 HPV18 20µg L1 HPV6 20µg L1 HPV11 40µg L1 HPV16 40µg L1 HPV18 20µg L1 HPV6 30µg L1 HPV11 40µg L1 HPV16 60µg L1 HPV18 40µg L1 HPV31 20µg L1 HPV33 20µg L1 HPV45 20µg L1 HPV52 20µg L1 HPV58 20µg Expression system Hi-5 Baculovirus Yeast: Saccharomyces cereviseae Yeast Saccharomyces cereviseae Schedule Intra muscular 0, 1, 6 months Intra muscular 0,2,6 months Intra muscular 0,2,6 months FDA licensed EMA licensed

7 Outline of the UK HPV vaccination programme Girls aged years (school year 8) immunised, as from the beginning of the 2008/09 school year. On going cohort but immunisation offered to any girl up to 18 A catch-up programme took place over two years: girls aged 15 to 18 offered immunisation in school year 2008 and doses 0, 1or 2 & 6 months doses 0 & 12 months 2014 onwards for year old cohort 7

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10 HPV vaccines Where are we now? population effectiveness disease virus prevalence duration of protection 10

11 First systematic review on impact following HPV vaccination PERIOD: NUMBER OF STUDIES: 20 (140M p-y of follow up) Compare outcomes in post- vs pre-vaccination periods Drolet et al, Lancet infect Dis

12 RR of GW during the first 4 years after Gardasil introduction relative to pre-vaccination period GIRLS & WOMEN COVERAGE >50% GIRLS & WOMEN COVERAGE <50% Drolet et al, Lancet Infect Dis 2015

13 Australia: Near disappearance of genital warts after commencement of national HPV program National HPV vaccination programme 1. Read et.al., Sex Transm Infect 2011; 87:544e547. doi: /sextrans Almost 90% decline in new cases of genital warts in both men and women < 21 yrs old 13

14 HPV 16/18 Prevalence (%) HPV 16/18 Prevalence By Age: Pre-vs. Post-immunisation Amongst Those Testing HR HPV Positive (England) Estimated vaccination coverage 60 65% 30% 0% Age group years years years Pre-immunisation Post-immunisation Data from Mesher etal 2013 Vaccine 17:

15 Hazard Ratio Significant Reductions in the Risk of Cervical Lesions in Denmark after the introduction of qhpv vaccine 1,a Compared to unvaccinated women, among vaccinated women ( 1 dose): The risk of atypia or worse was reduced by up to 60% Risks of CIN 2/3 and CIN 3 were reduced by up to 80% Risk of Cervical Lesions in Vaccinated Women Compared With Unvaccinated Women, October 2006 March 2012 b * * * * * * * *** Birth cohort C n=78, n=74, n=72, n=71, n=102,715 d e 0 Atypia or worse CIN 2/3 CIN 3 Cytologic Outcome CIN=cervical intraepithelial neoplasia. Statistical significance compared to unvaccinated women: *P<0.001, **P=0.005, ***P=0.01, =not significant. a Data are based on a cohort study of women born in Denmark from 1989 to 1999 linked to a nationwide Danish Pathology Data Bank. Individual HPV vaccination status was obtained from nationwide registries from 2006 to b Error bars represent 95% CIs. c Total cohort: N=399,244. d There were too few events to estimate hazard ratios for CIN 2/3 or CIN 3. e There were no events. 1. Baldur-Felskov B et al. J Natl Cancer Inst. 2014;106:djt460.

16 Incidence rates per 1000 person-year (p1000py) of CIN 1, 2 and 3 stratified by birth cohort and vaccination status Reductions of CIN1 29%, CIN2 50%, CIN3 55% in 20/21 year old females in Scotland, catch up cohort mean vaccine coverage 66% 16 Pollock etal 2014 Br J Cancer 111:1824

17 Duration of Protection Vaccines must induce robust immune memory for long term protection HPV vaccines need to give at least years of protection 17

18 effectiveness follow-up studies 4HPV vaccine First interim data from extension of Future II- no HPV 16/18- related cases of CIN 2+ or vulvar and vaginal cancers at up to 10 years A similar study independently conducted in Finland, confirms these findings with zero (0) HPV 16/18-related CIN 3+ cases. Effectiveness through 8 years in adolescents from adolescent extension study - no cases of HPV 6/11/16/18 infection or disease in the first interim analysis. 18

19 Cervarix HPV-001/007: Efficacy Against HPV-16/18 Endpoints (Up to 8.4 years) Endpoint Cervarix Cases N=193 Control Cases N=175 Vaccine Efficacy % 95% CI Incident Infection , Month Persistent Infection , Month Persistent Infection N=224 N= ,100 CIN ,100 CIN ,100 Rotelli Martins etal 2012 Hum Vaccin Immunotherap 8:

20 Where are we now? Both 2HPV and 4HPV VLP vaccines are highly efficacious with a good safety profile With high vaccine coverage 70% Population effectiveness Disease reduction warts >90% CIN2+ 50% Virus prevalence reduction Herd effects Duration of protection against disease caused by HPV 16/18 extends at least to 9 years (qhpv and bhpv) Protection is effected by antibody Prime boost (0,6 or 12 month) dosage schedule for female adolescents <15 years 20

21 Where are we going? 9HPV vaccine?predicted impact Male vaccination?universal?targeted MSM?One dose 21

22 Gardasil9: Key Results From Phase III Studies Topic HPV 6/11/16/18* HPV 31/33/45/52/58* Adolescents** Safety Results Non-inferior antibody response vs qhpv vaccine Similar protection against disease 97% protection against disease Non-inferior antibody response vs. women >15,000 subjects received 9vHPV vaccine AE profile similar to that of qhpv vaccine - More injection-site AEs (mostly mild/moderate in intensity) *Efficacy study in young women **Adolescents cannot be directly assessed for efficacy (low exposure to HPV). 22

23 Expected efficacy of 9HPV vaccine against HPV associated cancers de Sanjosé S et al. Lancet Oncol. 2010;11: Alemany L et al. Int J Cancer. 2015;136: Joura EA et al. Cancer Epidemiol Biomarkers Prev. 2014;23: Guan P et al. Int J Cancer. 2012;131:

24 Expected efficacy of 9HPV vaccine against cervical intra-epithelial lesions Serrano et al Infect Ag Cancer 2012;7:38. Guan P et al. Int J Cancer. 2012;131:

25 Where are we going? 9HPV vaccine?predicted impact Male vaccination?universal?targeted MSM?One dose 25

26 HPV is a Potent Carcinogen causing Multiple Related Cancers in Men and Women Penile Cancer ,700 Vulvar & Vaginal Cancer Anal Cancer 1,600 2,800 Anal Cancer H&N Cancer 11,600 2,300 H&N Cancer 23,000 Cervical Cancer MALE Genital warts 329, ,000 FEMALE Genital warts Annual new cancers and genital warts cases related to HPV 6,11,16 and/or 18 in Males and Females in Europe Annual number of new cancer cases calculated based on crude incidence rates from IARC database ( ) and population estimate Eurostat 2008; estimate Globocan 2008 for cervical cancer; published HPV prevalence rates were applied (for Europe, when available) Genital warts estimates based on incidence rates in UK, HPA

27 In industrialised countries cervical cancer is controlled by cervical screening but Other HPV associated cancers occurring in men and women -not amenable to screening are rising in incidence 27

28 Rate per 100,000 Increasing Incidence of Anal Cancer: Example of Scotland and England 1 Since the 1970s, the incidence of anal cancer in Scotland has more than doubled in both sexes. Incidence rates in England from 1990 to 2010 doubled in men and tripled in women Brewster DH et al. Br J Cancer. 2006;95:87 90 Wilkinson etal 2014 Colorectal Dis 16. Male Female Year of Diagnosis Mid-Count of 5-Year Period Age-standardized incidence rates of squamous cell carcinoma of the anus by year of diagnosis (5-year moving averages) and sex; Scotland,

29 Head and neck cancers in England by anatomic site: Distribution in 1995, 2011 and projected for 2025 Louie et al 2015 Oral Oncology 51:341 29

30 Pros The prevalence of genital HPV infection varies with age in women but not in men Fewer men (20-30%) than women (70-90%) make an immune response to HPV infection Men are not protected by antibody made after natural infection constantly reinfected BUT Why not immunise boys HPV vaccines protect against HPV infection and disease in men 30

31 Genital HPV: age related prevalence Women Men Manchester UK Peto et al Brit J Cancer 2004 Brazil, Mexico USA Giuliano AR et al. Cancer Epidemiol Biomarkers Prev. 2008;17:

32 Low Serum Antibody Response to HPV Infection in Men HPV-16 seroconversion values for males 1 were lower than previously reported values for females 2 Prevalent infections: 20% males 1 vs 94% females 2 Incident infections: 7% males 1 vs 67% females 2 HPV type (n) Seroconversion (%) at 24 mo (95% CI) Combined analysis (prevalent and incident infection) Prevalent infection a Incident infection a 16 (97) 13 ( ) (35) 36 ( ) (25) 8 ( ) (8) 12.5 ( ) (25) 4 ( ) (15) 6.7 (1 38.7) (36) 21.1 ( ) a Values from Kaplan-Meier estimates for cumulative type-specific seroconversion after prevalent or incident infections. CI=confidence interval; mo=months. 1. Edelstein ZR et al. J Infect Dis. 2011;204: Carter JJ et al. J Infect Dis. 1996;174:

33 Prophylactic Efficacy of Gardasil Against HPV 6/11/16/18 High Grade Anal Disease and EGL GARDASIL n=194 Placebo n=208 % # Cases IR/100 PY # Cases IR/100 PY Efficacy 95% CI AIN ,95 AIN ns AIN ns MSM Per Protocol Efficacy Population, End of Study data, P020 Palefsky J etal., N Egl J Med 365:1576 GARDASIL n = 1,397 Placebo n = 1,408 % # Cases IR/100 PY # Cases IR/100 PY Efficacy 95% CI EGL , 98 Per Protocol Efficacy Population, End of Study data, P020 Giuliano AR et al N Engl J Med, :

34 Cons Why not immunise boys MSW get herd protection from female only vaccination when coverage >80% - not cost effective MSM not protected by female only vaccination but could be vaccinated as a high risk group 34

35 Herd protection is not herd immunity Herd protection for men depends upon high HPV vaccine coverage in women Sustainability of herd protection depends upon sustained high coverage in women Immunising before onset of sexual activity protects ALL men irrespective of sexual preference Reduction in virus circulating in the population is essential for maximum disease impact, achieved by immunising boys and girls true herd immunity 35

36 targeting MSM for vaccination faces challenges?cost effectiveness depends upon price/dose and delivery cost/dose?ineffective at the age when sexual preference declared most MSM have been exposed Vaccine impact and cost effectiveness reduced?discriminatory discriminates against MSW and older women?stigmatising - danger of identifying this as a gay vaccine 36

37 Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials Aimée R Kreimer*, Frank Struyf*, Maria Rowena Del Rosario-Raymundo, Allan Hildesheim, S Rachel Skinner, Sholom Wacholder, Suzanne M Garland, Rolando Herrero, Marie-Pierre David, Cosette M Wheeler, for the Costa Rica Vaccine Trial and the PATRICIA study groups Lancet Oncology June We assessed vaccine efficacy against incident HPV-16/18 infection in the modified total vaccinated cohort ( received three doses, 1185 two doses, 543 one dose). Vaccine efficacy against incident HPV-16/18 infections for three doses was 77 0% (95% CI ), two doses was 76 0% ( ), and one dose was 85 7% ( ). 37

38 38

39 A and B, HPV16 (top) and HPV18 (bottom) specific antibody geometric means: by number of vaccine doses and study visit by American Association for Cancer Research Safaeian M et al. Cancer Prev Res 2013;6:

40 Thank you 40

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