The national human papillomavirus (HPV) vaccination programme - the move to two-dose schedule An update for registered healthcare practitioners August 2014 Quality Education for a Healthier Scotland 1
Aim To ensure that all immunisers involved with the HPV immunisation programme are aware of the move to the two-dose schedule Quality Education for a Healthier Scotland 2
Learning outcomes The immuniser will be able to: Describe the aetiology of HPV infection and cervical cancer Describe how HPV is transmitted Describe the epidemiology of HPV infection Describe the dosage and schedule for Gardasil, contraindications etc Be aware of all sources of additional information Quality Education for a Healthier Scotland 3
Contents 1. Human Papillomavirus (HPV) infection 2. Diseases caused by HPV 3. HPV vaccine 4. The HPV immunisation programme Quality Education for a Healthier Scotland 4
1. HPV infection Quality Education for a Healthier Scotland 5
Human Papillomavirus Is a small DNA virus Infects the epithelium i.e. the deeper layers of the skin and mucosal lining of organs such as the vagina and mouth More than 100 types, of which 40 infect the genital area Classified into high-risk (HR) which can cause cancer and low-risk (LR) which can cause genital warts Quality Education for a Healthier Scotland 6
HPV infection Is often asymptomatic Usually resolves spontaneously - 90% do so within two years Persistent infection with HR types causes the cell changes that can eventually lead to cancer Quality Education for a Healthier Scotland 7
HPV infection is very common HPV is common most women will have been infected at some point in their lives. At least 75% will have been infected by the age of 50 Incidence of infection increases from age 14 Women are most likely to be infected in their late teens and early twenties Scottish data on unvaccinated 20 year olds show that 50% have a current HPV infection with at least one HPV type So it s unusual not to catch HPV Quality Education for a Healthier Scotland 8
How HPV is spread HPV is spread by direct physical contact Any genital contact is important, not just sexual intercourse Hand to genital contact may cause some infections Anyone who is sexually active is at risk Risk increases with the number of sexual partners Quality Education for a Healthier Scotland 9
2. Diseases caused by HPV Quality Education for a Healthier Scotland 10
High risk (HR) HPV causes cervical cancer >99% of cases of cervical cancer are caused by HPV HPV 16 and 18 together cause over 75% of cervical cancer 11 other high risk types have been identified that can cause cancer Quality Education for a Healthier Scotland 11
How HPV infection may lead to cancer HPV infection usually resolves spontaneously - 90% do so within two years Persistent infection leads to cells becoming damaged and pre-cancerous HPV infections can t be treated but pre-cancerous changes can be detected by screening and removed Cancer - abnormal uncontrolled growth of tissues can occur after many years Co-factors increase the likelihood of cervical cancer, particularly smoking Quality Education for a Healthier Scotland 12
Epidemiology of cervical cancer 3378 cases of cervical cancer diagnosed in the UK in 2009 326 in Scotland 1/3 of these died Third most common cancer of women worldwide* Most cases occur in women in their late 30s or in their 70s/80s (latter group not screened when younger) In developed countries, most cases are prevented by cervical screening (death rates about 60% lower than 30 years ago, mainly due to screening) *Recent evidence: http://emedicine.medscape.com/ article/253513-overview) Quality Education for a Healthier Scotland 13
Cervical cancer - cases and rates by age group, in the UK, 2007-2009 500 25 Cases 400 300 200 100 Cases Rates per 100 000 20 15 10 5 Rates per 100 000 0 15 to 19 20 to 24 25 to 29 30 to 34 35 to 39 40 to 44 45 to 49 50 to 54 55 to 59 60 to 64 65 to 69 70 to 74 75 to 79 80 to 84 85+ 0 Age group Source: Cancer Research UK Quality Education for a Healthier Scotland 14
Cervical screening Cervical screening does not prevent HPV infection, or pre-cancerous changes but allows early detection and treatment Screening remains important for all women as immunisation does not protect against all HPV types All women aged 20 to 60 are currently eligible for cervical screening For unimmunised women screening remains the most effective way to reduce their risk of cervical cancer Quality Education for a Healthier Scotland 15
Genital warts in Scotland Number 400 350 300 250 200 150 100 50 Numbers of diagnoses of genital warts by age and sex, 2009 Males Females Number Trends in diagnoses of genital warts in females by age, 2000-2009 1 400 1 200 1 000 800 600 400 200 15-19 20-24 25-34 35-44 >45 0 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 Age Source: ISD Scotland: STISS & NASH 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 Year Quality Education for a Healthier Scotland 16
Epidemiology of genital warts Genital warts are the commonest viral sexually transmitted infection in the UK 4% of adults aged 18 to 44 reported having been diagnosed with genital warts At least 7000 new diagnoses each year in Scotland Mainly in young adults aged 16 to 24 HPV types 6 and 11 cause 90% of these cases Genital warts can be recurrent and difficult to treat Genital warts are not life threatening but can cause significant distress and substantial healthcare costs Quality Education for a Healthier Scotland 17
HPV vaccine uptake 2008/9-2011/12 Table 1: Annual HPV immunisation uptake rates for the S2 routine cohort by the end of the school year and one year later. School Year % Uptake Dose 1 End of school year % Uptake Dose 1 1 year later School Year % Uptake Dose 2 End of school year % Uptake Dose 2 1 year later School Year % Uptake Dose 3 End of school year % Uptake Dose 3 1 year later 2008/09 93.7 94.5 2008/09 92.7 93.8 2008/09 89.4 92.4 2009/10 92.6 93.6 2009/10 91.1 92.5 2009/10 86.9 90.9 2010/11 91.8 92.9 2010/11 90.2 92.0 2010/11 81.0 90.1 2011/12 93.1 94.2 2011/12 91.7 93.4 2011/12 82.8 91.4 Routine immunisation of S2 girls exceeds 90% uptake for all three doses. Quality Education for a Healthier Scotland 18
Early impact of HPV vaccine on HPV infection HPV type from anonymised LBC samples in 2009-2012 cohort: unvaccinated vs vaccinated Percentage of women positive for any HPV 35 30 25 20 15 10 5 0 Unvaccinated (0 dose) Vaccinated (3 doses) 6 11 16 18 26 31 33 35 39 42 43 44 45 51 52 53 56 58 59 66 68 70 73 82 HPV type Three doses of HPV vaccine associated with a significant reduction of HPV 16, 18 and affords cross-protection against HPV 31, 33 and 45*. Quality Education for a Healthier Scotland 19
3. HPV vaccines Quality Education for a Healthier Scotland 20
Vaccine for HPV Immunisation Programme Gardasil From September 2012 Gardasil has been used for HPV immunisation programme Quadrivalent (types 6,11,16,18) Sanofi Pasteur MSD Licensed from age 9 years Pre-filled syringe with needle Container dimensions: 47x23x150mm Basic NHS price 86.50 when prescribed (contract price unavailable) Quality Education for a Healthier Scotland 21
Pre-filled 0.5 ml syringe Quality Education for a Healthier Scotland 22
Gardasil - composition Brand and generic name Gardasil suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) Gardasil composition Active ingredients HPV type 6 L1 protein (20 microgram) HPV type 11 L1 protein (40 microgram) HPV type 16 L1 protein (40 microgram) HPV type 18 L1 protein (20 microgram) Adjuvant is amorphous aluminium hydrophosphate sulphate (225 microgram Al) Excipients Sodium Chloride L-Histidine Polysorbate 80 Sodium borate Water for injections Quality Education for a Healthier Scotland 23
Storage of HPV vaccine Cold chain must be maintained Store in original packaging Protect from light Transport between +2 C and +8 C Store vaccine in schools in validated cool boxes Quality Education for a Healthier Scotland 24
Gardasil Dosage and Schedule Two-dose schedule should only be used in girls who can receive first dose before they are 15 years of age Two-dose schedule: First dose of 0.5ml Second dose of 0.5ml at least six months after the first dose Best completed within 24 months If course is interrupted, resume; do not repeat Quality Education for a Healthier Scotland 25
Gardasil Dosage and Schedule Three-dose schedule should be used in girls who: Start a course of HPV vaccination from age 15 years Are HIV positive or are immunocompromised at time of vaccination Three dose schedule First dose of 0.5ml Second dose of 0.5ml at least one month after the first dose Third dose of 0.5ml at least three months after the second dose Best completed within 12 months If course is interrupted, resume; do not repeat Quality Education for a Healthier Scotland 26
Minimum interval for third dose There is no clinical data on whether the interval between doses two and three can be reduced below three months - - Where the second dose is given late and there is a high likelihood that the individual will not return after three months or if, for practical reasons it is not possible to schedule a third dose within this timeframe, then a third dose can be given at least one month after the second dose. Quality Education for a Healthier Scotland 27
Administration of Gardasil Vaccine comes as a suspension - shake before use to form a white cloudy liquid Given by intramuscular injection into the deltoid Can be given at same time as other vaccines such as Td/IPV, MMR and hepatitis B In separate site, preferably in a different limb Quality Education for a Healthier Scotland 28
Contraindications Confirmed anaphylactic reaction to a previous dose Confirmed anaphylactic reaction to any component of the vaccine Defer immunisation if recipient has fever or is acutely unwell HPV vaccine is not advised in pregnancy Quality Education for a Healthier Scotland 29
Immunosuppression Girls with immunosuppression can be safely immunised, although immunisation may be less effective Quality Education for a Healthier Scotland 30
Reported vaccine side effects Vaccines undergo rigorous safety testing as part of licensing process. The most common adverse reaction after HPV vaccines Mild to moderate short lasting pain at injection site Redness and an immediate localised stinging sensation has been reported at injection site Headache, fatigue, muscle aches and low grade fever have been commonly reported Anaphylaxis is possible but extremely rare Quality Education for a Healthier Scotland 31
HPV vaccine safety: pharmacovigilance Yellow card scheme Voluntary reporting system for suspected adverse reaction (ADR) to medicines/ vaccines Success depends on early, complete and accurate reporting Report even if uncertain about whether vaccine caused the condition http://www.mhra.gov.uk/yellowcard Will require brand name, batch number and as much information about the incident as possible See chapter 8 of Green Book for details Quality Education for a Healthier Scotland 32
Longer term protection The immune response to HPV vaccine is expected to be long-lasting Data are still being reported from long term follow up of women in the vaccine trials The latest data for Gardasil was reported in 2011 and shows a trend of continued protection in women who were vaccinated up to seven years previously. Follow up will continue for ten years Quality Education for a Healthier Scotland 33
4. The HPV immunisation programme Quality Education for a Healthier Scotland 34
Child Health Surveillance Programme School (CHSP-S): key functions NHS (CHI) based data pupil data downloaded from education systems data (school, year, class) Pre-printed consent forms issued via schools Produces attendance registers for use in school immunisation sessions Written confirmation of immunisation returned to girls/ parents School immunisation data recorded on CHSP-S Quality Education for a Healthier Scotland 35
Resources Leaflets Health Scotland. A guide to the human papillomavirus (HPV) vaccine (2014) is available from: http://www.immunisationscotland.org.uk/documents/5988.aspx Health Scotland. What to expect after immunisation: young people (2013) is available from: http://www.immunisationscotland.org.uk/documents/6132.aspx Online video A video to support group sessions in the school setting is available from: http://www. immunisationscotland.org.uk/hpv Q and A for professionals A resource for professionals can be found at http://www.nes.scot.nhs.uk/educationand-training/by-theme-initiative/public-health/health-protection/immunisation.aspx Quality Education for a Healthier Scotland 36
Further information http://www.immunisationscotland.org.uk/hpv NHS inform helpline - 0800 22 44 88 Green Book: https://www.gov.uk/government/publications/ human-papillomavirus-hpv-the-green-book-chapter-18a Chief Medical Officer s letter, Human papillomavirus (HPV) vaccination programme: change in schedule from 3 to 2 doses is available from: http://www.sehd.scot.nhs.uk/cmo/ CMO(2014)20.pdf Quality Education for a Healthier Scotland 37