2017 Human Papillomavirus Immunisation Programme

Transcription

1 2017 Human Papillomavirus Immunisation Programme 1 1

2 HPV infection HPV is a virus that infects the skin and mucous membranes Most infections clear within 18 months Clearing infection does not confer immunity - the person may not know they have been infected Persistent infection with oncogenic types may cause cancers HPV cancers affect genitourinary and the head-neck regions HPV related oropharyngeal cancers are increasing Elrefaey S, Massaro MA, Chiocca F, Ansarin M (2014) HPV in oropharyngeal cancer: the basics to know in clinical practice Acta Otophinolaryngol Ital 2014 Oct; 34(5): HPV virus image WHO training package for HPV vaccine introduction 2 2

3 >40 Types HPV types differ by disease Mucosal sites of infection association Cutaneous sites of infection > 80 Types High risk (oncogenic) HPV 16, 18 most common Low risk (non-oncogenic) HPV 6, 11 most common Cervical Cancer Anogenital Cancers Oropharyngeal Cancer Cancer Precursors Low Grade Cervical Disease Genital Warts Laryngeal Papillomas Low Grade Cervical Disease 3 Common Hand and Foot Warts 3

4 Mechanism of transmission for genital and oropharyngeal HPV Sexual (common) Any genital contact, including oral sex Increased likelihood with # partners Condoms reduce but not protect HPV Infection Non Sexual Mother to newborn Fomites (inanimate objects or substances) possible - not proven Most infections subclinical 4 4

5 Genital wart epidemiology HPV causes all ano-genital warts Globally 90% caused by HPV 6 & 11 Genital warts are the most common viral sexually transmitted infection (STI) in NZ Genital warts, although not life threatening can be recurrent and difficult to treat 5 5

6 HPV infection progression to cancer The HPV virus infects cells The viral DNA integrates into the host cell Persistent infection leads to cell changes Cell changes can lead to pre-cancerous lesions can take about 10 years Cancer develops abnormal uncontrolled growth of tissues Once integrated into the cell DNA, HPV infection cannot be treated but cell changes/lesions can be detected by screening and then excised 6 6

7 Cancers caused by high-risk HPV types Cervix Penis Vulva, Vagina Anus Oropharynx >99% >63% >70% >90% >70% 7 7

8 HPV types in cervical cancer Additional serotypes in HPV9 8 8

9 Natural history of cervical carcinogenesis Diagram adapted from Schiffman M 2003 Images: ihv.org and HealthCure.org

10 NZ epidemiology of cervical cancer Annually in New Zealand about 145 cervical cancer cases are diagnosed and 54 women die from the disease Cervical cancer ranks as the 13th cause of female cancer in New Zealand However it is the 4th most common female cancer in women aged 15 to 44 years in New Zealand Significant disparities exist for Māori and Pacifica women New Zealand Human Papillomavirus and Related Cancers, Fact Sheet 2016 (October 7, 2016) ICO Information Centre on HPV and Cancer 10 10

11 Other genital cancers Anal and penile cancers Rare but increasing Associated with HPV serotypes 16 & 18 Penile cancer affects older men Anal cancer affects men who have sex with men and immunocompromised men and women Twice as common in women Vulval and vaginal cancers Rare but increasing Associated with HPV type 16 Image: Image: thetruthaboutcancer.com 11 11

12 Head and neck cancers Oral cavity cancers, associated with tobacco and alcohol, are decreasing Cancers of the tongue, base of the tongue & other oropharyngeal sites are increasing These are associated with HPV 16 In New Zealand oropharyngeal cancers have increased rapidly since 2005 These are at least twice as common in men than women Chaturvedi A. K et al (2013) Worldwide Trends in incidence rates for oral cavity Journal of Clinical Oncology Vol. 31 No 36 Elrefaey S, Massaro MA, Chiocca F, Ansarin M (2014) HPV in oropharyngeal cancer: the basics to know in clinical practice Acta Otophinolaryngol Italy 2014 Oct; 34(5): Image:

13 HPV Vaccines Recombinant L1 capsid proteins that form virus-like particles (VLP) Non-infectious and non-oncogenic Produce higher levels of neutralizing antibody than natural infection Image: CDC presentation 2016: You are the key to HPV cancer prevention 13 13

14 HPV9 vaccine HPV4 covers >70% of oncogenic types leading to cervical cancer - 6,11,16,18 HPV9 covers >87% of oncogenic serotypes: 6, 11,16,18 plus 31,33,45,52,58 HPV9 First licensed in US in 2014; Europe in 2015; NZ in late 2015 Richard Roden, Wu T (2006) How will HPV vaccines affect cervical cancer? Nature Reviews Cancer 6, doi: /nrc

15 From 1 st January 2017 HPV - 4 valent vaccine (Gardasil) will be replaced with the 9 valent vaccine (Gardasil 9) - Funded for males and females up to 27 years old - 2 dose schedule for those 14 years and under - 3 dose schedule for those years inclusive 15

16 HPV vaccine schedules From 1 January 2017 Aged 9 14 years inclusively Two doses 0, 6 months No accelerated schedule If two doses are given less than 6 months apart, or If second dose is given at age 15 years or older A third dose is required 4 months after the second 16

17 HPV vaccine schedules From 1 January 2017 HPV4 or HPV9 fully interchangeable Aged years and older Three doses 0, 2, 6 months or 0, 1, 4 months 17

18 HPV vaccine eligibility From 1 January 2017 Males and females: Aged 9 26 years inclusively Start before 27 years funded for complete course Post-stem cell or solid organ transplantation, HIV-positive aged 9 26 years inclusively Three dose course for all ages, i.e years have three doses Post-chemotherapy aged 9 26 years inclusively one additional/booster dose 18

19 2017 HPV schedule HPV4 or HPV9 fully interchangeable Start with HPV4 may complete HPV4 or with HPV9 Those who had funded HPV4 course not eligible for HPV9 Count all funded doses given, do not restart Same schedule for both HPV4 and HPV

20 Gardasil 9 availability School-based programme Commencement of school year 20

21 Current HPV programme targets Girls born in 2003 (vaccinated in 2016) Dose three (3) target is 70% Measured in 2017 Girls born in 2004 (due vaccination 2017) Boys are not included in the targets yet Dose two (2) target is 75% Measured in 2018 Image: Centers for Disease Control (2016) You Are the Key to HPV Cancer Prevention web based training programme 21

22 HPV delivery in primary care Two doses funded is the standard schedule For to year olds who decline in school based programme Three dose schedule is catch-up if missed or high risk Aged years old inclusive years old with positive HIV, immune-deficiency, or post transplant An additional dose post chemotherapy Completion only funded if first dose given before 27 Resource permitting primary care can call year olds who have not completed a course of HPV vaccine Those who are now eligible and previously purchased HPV vaccine or had HPV2 will be funded 22

23 HPV vaccine duration of immunity Studies suggest the vaccine protection is longlasting Available evidence indicates protection for at least 10 years with HPV4 And no sign of waning immunity Multiple cohort studies are in progress to monitor the duration of immunity De Vincenzo R, Conte C, Ricci C, Scambia G, & Capelli G (2014) Long-term efficacy and safety of human papillomavirus vaccination. International Journal of Women s Health 2014:6 23

24 HPV vaccine profile Extensive post-market surveillance no safety signals raised Summary of post-market safety associations Syncope (related to injection reaction) Possible skin infections ( probably injection site reactions misclassified) Pregnancy (contraindicated but inadvertent admin) No theoretical risk (not a live vaccine) No differences in outcome pregnant/non pregnant Haupt et al An overview of Quadrivalent HPV vaccine safety PIDJ Sept

25 HPV9 vaccine 15,000 subjects in 31 countries HPV9 slightly more reactogenic than HPV4 injection site reactions: only significant difference was in injection site swelling common systemic events all slightly higher e.g. headache 14.6% (13.7% with HPV4), pyrexia 5% (4.3% with HPV4) Moreira E D, Block S L, Ferris D et al (2016) Safety profile of the 9-valent HPV vaccine: a combined analysis of 7 phase III clinical trials Pediatrics 2016;138 (2) e

26 HPV9 vaccine and pregnancy Remains a contraindication 2950 accidental pregnancies (out of 15,000 subjects) were followed up Outcomes similar to placebo (HPV4) group No increase in rates of spontaneous miscarriage, birth defects or other pregnancy outcomes compared to general population Moreira E D, Block S L, Ferris D et al (2016) Safety profile of the 9-valent HPV vaccine: a combined analysis of 7 phase III clinical trials Pediatrics 2016;138 (2) e Image: Let s talk about immunisation resource, Ministry of Health 26 26

27 What about stories on the internet about... Complex regional pain syndrome (CRPS) Postural Orthostatic Tachycardia Syndrome (POTS) The evidence: >15,000 received 1-dose HPV9 Pregnancies were followed to outcome (n=2950) Safety outcomes followed for 7 72 months New medical conditions collected at each visit 2 developed CRPS, both related to a previous injury 2 developed POTS, one case >3 years after vaccination Moreira E D, Block S L, Ferris D et al (2016) Safety profile of the 9-valent HPV vaccine: a combined analysis of 7 phase III clinical trials Pediatrics 2016;138 (2) e

28 Significant clinical and observational data support the positive safety profile of HPV vaccines Rare risk of anaphylaxis no increase No increased risk for serious events Exception syncope (fainting) at time of injection HOWEVER positive impact on disease seen in countries using vaccine, including NZ! 28 28

29 HPV Vaccine Effectiveness Monitoring Impact of HPV Vaccine Programs on HPV-Associated Outcomes 29 29

30 Effectiveness of HPV4 vaccine Over 130 published studies to June 2016 Maximal reduction of around 90% for HPV infection, genital warts and cervical abnormalities (57 studies) Profound reduction in genital warts (e.g. Australia and Denmark) Elimination of genital warts may be possible Mediocre coverage also leads to significant reductions Garland SM, Kjaer SK, Muñoz N, et al. Impact and Effectiveness of the Quadrivalent Human Papillomavirus Vaccine: A Systematic Review of Ten Years of Real-World Experience. Clin Infect Dis 2016:ciw

31 HPV vaccination and genital warts in Australia 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:f

32 Summary: effectiveness of HPV4 Declines in cervical dysplasia Data to date support long term effectiveness Herd immunity demonstrated for infection, genital warts and cervical disease Garland SM, Kjaer SK, Muñoz N, et al. Impact and Effectiveness of the Quadrivalent Human Papillomavirus Vaccine: A Systematic Review of Ten Years of Real-World Experience. Clin Infect Dis 2016:ciw

33 Expected vaccine responses Expected vaccine responses for HPV4: Fainting, especially adolescents Pain, redness and swelling at the injection site Headache Fever less than 39 C Slightly increased for HPV9 due to increased levels of the adjuvant and some antigens Moreira E D, Block S L, Ferris D et al (2016) Safety profile of the 9-valent HPV vaccine: a combined analysis of 7 phase III clinical trials Pediatrics 2016;138 (2) e

34 Contraindications to HPV9 Contraindications Anaphylaxis to a previous dose of HPV vaccine or any of the vaccine components Pregnancy Precautions Acute severe febrile illness postpone vaccination (minor infection is not a contraindication) AEFI (not anaphylaxis) to previous dose of HPV vaccine 34 34

35 Informed consent School-based programmes have a national consent form for the parent/caregiver to complete regardless of child s age Consent in general practice usually verbal consent People over 16 years can consent People younger than 16 can give consent in primary care if the health professional feels they are competent to decide Under 16 years it is preferable to involve the parent/guardian 35 35

36 Framing the HPV conversation It s all about the way you say it prepare! 36 36

37 HPV communication Unique challenges of the HPV vaccine programme: The vaccine targets youth before their sexual debut - recommended for those 9 13 years of age However the benefits of the vaccine are not seen for years, even decades The long term plan is the programme will will become a routine health strategy to prevent cancer WHO (2016) HPV vaccine communication: Special considerations for a unique vaccine 37 37

38 Reasons parents won t initiate HPV vaccination for children Not sexually active Not recommended Safety concern/side effects Not needed or necessary Lack of knowledge Percent MMWR (2014) Human Papillomavirus Vaccination Coverage Among Adolescents, , and Post licensure Vaccine Safety Monitoring, United States 63/69 Tung I, Machalek D, Garland Suzanne (2016) Attitudes, knowledge and factors associated with HPV uptake in adolescent girls and young women in Victoria Australia 38 38

39 Not sexually active Why so young? HPV vaccination works best at the recommended ages of 11 or 12 years. That s why I d like for your son to start the HPV vaccine series today. If we delay till he is older he may need 3 injections instead of two as the immune system is more efficient when given younger 39 39

40 Not sexually active I m just worried that my child will perceive this as a green light to have S-E-X Numerous research studies have shown that getting the HPV vaccine does not make kids more likely to be sexually active or start having sex at a younger age. Starting the HPV vaccine series today will give your child the best protection possible for the future

41 Reasons parents won t initiate HPV vaccination for children Not sexually active Not recommended Safety concern/side effects Not needed or necessary Lack of knowledge MMWR 2014; 63(29);625-6 Brewer NT, Hall ME, Malo TL, et al. Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. Pediatrics. 2017;139(1):e ; Percent 41 41

42 Eliminating missed opportunities Look for opportunities to improve HPV coverage 91% of 13- to 17-yearold U.S. girls would have received at least their first HPV vaccine dose by 2012 if all missed opportunities for HPV vaccination had been eliminated. Missed opportunity: Healthcare encounter when some, but not all ACIP-recommended vaccines are given. HPV-1: Receipt of at least one dose of HPV. MMWR. 63(29);

43 Same way/ Same day campaign Same way: group all of the early adolescent vaccines Recommend HPV vaccination the same way you recommend the Tdap vaccine Same Day: Recommend HPV vaccine today Now that Sophia/Jack is 11, she/he is due for two vaccines. These will help protect her/him from HPV cancers and pertussis. We can give those injections today. Brewer NT, Hall ME, Malo TL, et al. Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. Pediatrics. 2017;139(1):e

44 Reasons parents won t initiate HPV vaccination for children Not sexually active Not recommended Safety concern/side effects Not needed or necessary Lack of knowledge Percent MMWR 2014; 63 (29); Moreira E D, Block S L, Ferris D et al (2016) Safety profile of the 9-valent HPV vaccine: a combined analysis of 7 phase III clinical trials Pediatrics 2016;138 (2) e

45 Safety concerns/side effects I know there are stories in the media and online about vaccines, and I can see how that could concern you. However, I want you to know that HPV vaccine has been carefully studied for many years by medical and scientific experts. Based on all of the data, I believe HPV vaccine has a very good safety profile. Haupt et al An overview of Quadrivalent HPV vaccine safety PIDJ Sept

46 Reasons parents won t initiate HPV vaccination for children Not sexually active Not recommended Safety concern/side effects Not needed or necessary Lack of knowledge MMWR 2014; 63(29); ; Elrefaey S, Massaro MA, Chiocca F, Ansarin M (2014) HPV in oropharyngeal cancer: the basics to know in clinical practice Acta Otophinolaryngol Ital 2014 Oct; 34(5): Percent 46 46

47 Not needed/necessary Why does my child need HPV? HPV vaccination is important because it prevents cancer. That s why I m recommending that your child start the HPV vaccine series today. MMWR 2014; 63(29); ; 47 47

48 Reasons parents won t initiate HPV vaccination for children Not sexually active Not recommended Safety concern/side effects Not needed or necessary Lack of knowledge MMWR 2014; 63(29); ; Percent 48 48

49 Lack of knowledge What cancers are caused by HPV? Certain HPV types can cause cancer of the cervix, vagina, and vulva in females, cancer of the penis in men, and in both females and males, cancers of the anus and the throat. We can help prevent infection with the HPV types that cause these cancers by starting the HPV vaccine series today. Saraiya M, Unger E, Thompson T, et al (2015) Assessment of HPV types in cancers: Implications for current and 9-valent HPV vaccines. Journal of National Cancer Institute 107 (6) 49 49

50 Lack of knowledge How do you know if the vaccine works? Ongoing studies are showing that HPV vaccination works very well and has decreased HPV infection, genital warts, and cervical precancers in young people, in the years since it has been available. Starting the vaccine series today will help ensure your child gets the best protection possible. Garland SM, Kjaer SK, Muñoz N, et al. Impact and Effectiveness of the Quadrivalent Human Papillomavirus Vaccine: A Systematic Review of Ten Years of Real-World Experience. Clin Infect Dis 2016:ciw

51 Talking to the boys Why do boys need HPV vaccine? HPV infection can cause cancers of the penis, anus, and throat in men and it can also cause genital warts. Getting HPV vaccine today for your son can help prevent the infection that can lead to these diseases. Saraiya M, Unger E, Thompson T, et al (2015) Assessment of HPV types in cancers: Implications for current and 9-valent HPV vaccines. Journal of National Cancer Institute 107 (6) 51 51

52 HPV key points Persistent HPV infection of oncogenic types can result in cancers In New Zealand Māori and Pacific have a higher risk of HPV related-cancer, especially cervical cancer Vaccines available, with excellent safety profiles HPV vaccine prevents types causing most cancers Cervical screening is still essential 52 52

53 HPV immunisation key points HPV vaccines are more effective when administered at younger ages Less doses required under age 15 years School programmes result in higher coverage and reduced inequities Primary health can provide catch-ups to improve coverage Specific communication is needed to address community concerns 53

54 14 year old check Has had 11 year old Boostrix? 2-3x HPV vaccines? 2x MMR vaccines? All other vaccines eligible for? Special vaccines? 54

55 Deltoid muscle site for injection Located in the lateral aspect of the upper arm in line with the axilla Arm positioned at the patients side and relaxed The whole of the upper arm is exposed to correctly identify injection site Injection volume should not exceed 0.5ml in children and 1ml in adults 55

56 Questions?? 56