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Immunisation Against Human Papilloma Virus David Green – Immunisation Coordinator and Infection Control Nurse Contents • • • • • • • Epidemiology and pathology of infection Conditions caused by HPV HPV Vaccine Consent The DH immunisation campaign Results Future challenges Brain Teaser • What is the connection between this moth and the HPV vaccine? Cabbage looper or Trichoplusia ni HPV infection • Human papilloma virus (HPV) is a small DNA virus. • It infects the deeper layers of the skin and internal lining of organs such as the vagina and mouth. • HPV is often asymptomatic. • There are more than 100 types, of which 40 infect the genital area. • HPV infections normally resolve spontaneously 90% do so within two years. • Persistent HPV infection causes the cell changes that eventually lead to cancer. HPV Transmission • 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. • The risk of acquiring HPV increases with the number of sexual partners. Epidemiology of genital HPV infection • HPV infection is common – at least half of all sexually active women will be infected by a strain of genital HPV strain in their lifetimes. • The rate of genital HPV infection increases from age 14. • Women are most likely to be infected in their late teens and early twenties. • 15% of 20 to 24-year-old women were recently infected with HPV 16 or 18. Effects of HPV infection • The HPV virus infects cells and then integrates its DNA in to the DNA of the host cell. • Persistent infection leads to cells becoming damaged and abnormal. • Eventually cancer - abnormal uncontrolled growth of tissues – occurs after many years. • HPV infections can’t be treated but abnormal changes can be detected by screening and removed. Categories of genital HPV infection • Genital HPV types are categorised as either: – high-risk (oncogenic) types - that cause cervical intraepithelial neoplasia and invasive cancer, and – low-risk types - that cause genital warts. • 99% of all cervical cancer cases are caused by HPV infection. • Two high-risk types, HPV 16 and 18, cause over 70% of cervical cancers. • Other HPV types can also cause cervical cancer. HPV types that cause cervical cancer HPV type Percentage of cervical cancer cases caused by HPV type Cumulative percentage 16 58.1% 58.1% 18 15.7% 73.8% 33 4.4% 78.2% 31 4.0% 82.2% 45 2.9% 85.1% 35 1.6% 86.7% 58 1.2% 87.9% 56 1.0% 88.9% 52 0.6% 89.5% 39 0.2% 89.7% 51 0.2% 89.9% 68 0.3% 90.2% 59 0.1% 90.3% Other 1.4% 91.7% No type identified 8.3% 100% Adapted from Smith JS et al., 2007; Int J Cancer. 121(3):621-32. Percentage of different cancer types caused by high-risk HPV types Cancer site Cervix Percentage of cases caused by HPV > 99% Penis 40% Vulva, vagina 40% Anus 90% Mouth 3% Oropharynx 12% Source: Prof Margaret Stanley, University of Cambridge Epidemiology of cervical cancer • 2253 cases of invasive cervical cancer were diagnosed in England in 2005. • It is the second most common cancer of women worldwide. • Most cases occur in women in their late 30s or in their 70s/80s (latter group were not screened when younger). • In developed countries, most cases are prevented by cervical screening. • In the UK, death rates are about 60% lower than 30 years ago, mainly due to screening. Number of cases and age specific rates of newly diagnosed cervical cancer, England 2005 Age group 85+ 80-84 75-79 70-74 65-69 60-64 0 55-59 0 50-54 5 45-49 100 40-44 10 35-39 200 30-34 15 25-29 300 20-24 20 Cases per 100,000 population Cases per 100,000 population 400 15-19 Number of cases Number of cases HPV Immunisation Cervarix • Cervarix® is a bivalent vaccine manufactured by GlaxoSmithKline. • Cervarix® protects against HPV types 16 and 18. • Cervarix® was chosen after assessment of the two available vaccines against a wide range of criteria, such as the scientific data on vaccine effectiveness and costeffectiveness • Costs approx £80 per dose Cervarix Controversy • The competitor brand (Gardasil) protects against strains 6, 11, 16 and 18. • Use of Cervarix rather than Gardasil has been called “short sighted” (Terrence Higgins Trust) and a “missed opportunity” (FPA). • Prevention of cervical cancer is the primary purpose of the HPV vaccination programme. The nature of Cervarix vaccine • Proteins that coat the HPV virus are made using DNA recombinant technology in cells that have been infected by baculoviruses (insect viruses) which uses cells derived from Trichoplusia ni. • These purified proteins assemble themselves into small spheres called virus-like particles (VLPs). • VLPs cannot cause HPV infection or cancer. • The VLPs produce immunity to HPV. • Immunised individuals mount a rapid immune response when subsequently exposed to HPV. Duration of immunity • The immune response to HPV vaccination lasts at least six years (the current maximum length of post-vaccination follow-up). • For at least five years post-vaccination, antibody levels have been shown to be higher from vaccination than from natural infection. • At present there is no evidence for waning immunity, but important long-term follow-up studies are taking place to establish whether boosting will be necessary. • Routine HPV vaccination will save the lives of around 400 women each year. Consent • Consent is being asked for a course of treatment (all three doses) • For year 8 girls (aged 12 and 13) the person with parental responsibility gives consent • Year 13 (aged 17 and 18) girls give their own consent Vaccine schedule and administration • Schedule for Cervarix®: – first dose of 0.5ml HPV vaccine; – second dose of 0.5ml, at least one to two months after the first; and – a third dose of 0.5ml, at least six months after the first. • HPV vaccination is normally given by the usual route, in the upper arm by IM injection HPV Immunisation Program Vaccination of boys and young women 18 and over • The benefits of HPV vaccination are less for boys and JCVI has advised that vaccination of boys is not cost-effective. • The vaccination of girls will reduce HPV infections in boys by a herd immunity effect. • The DH are not currently planning to offer vaccine to those aged 18 and over as part of a national programme • All young women will still be covered by the cervical screening programme and should still be actively promoted by HCWs. The HPV routine and catch-up vaccination schedule for girls and young women in England, as of September 2008 School year 7 School year 8 2008/09 2009/10 2010/11 2011/12 Routine programme for Year 8 girls Catch-up programme for older girls School year 9 School year 10 School year 11 School year 12 Girls aged 1718 (school year 13) Implementation in Calderdale PCT • A schools-based programme was used for those in school as it was likely that: – vaccine coverage will be higher in schools – costs would be lower than a GP-delivered model, and – using schools would be more acceptable to parents/pupils. – Opt out of school program available if necessary • Offering vaccination in the summer term is problematic, so an early start in the school year was thought necessary. Implementation in Calderdale Schools • • • • Dose one - Sept 08 (plus mop ups) Dose two – Nov 08 (plus mop ups) Dose three – March 09 (plus mop up) Those who miss mop up could attend their GP practice to receive outstanding dose(s) Regional and National Comparison (Jan 09) Dose Calderdale Y&H Region (Average) 90% England (Average) One (Yr 8) 92% One (Yr 13) 46% 32% 32% Two (Yr 8) 89% 78% 73% Two (Yr 13) 37% 15% 21% 82% Uptake in Calderdale (as of 31.3.09) Year 8 (12 and 13 years old) = • Dose 1 = 94.4% • Dose 2 = 91.6% • Dose 3 = 81.5% Year 13 (17 and 18 year olds) = • Dose 1 = 56.9% • Dose 2 = 43.6% • Dose 3 = 27.7% Future challenges • Year 8 - To bring uptake of doses 2 and 3 up to dose 1 level • Year 13 – To achieve 90% uptake! • To implement the new “accelerated” HPV immunisation campaign from Sept 09. The Accelerated HPV Campaign School year 7 2008/09 2009/10 2010/11 2011/12 School year 8 School year 9 School year 10 School year 11 School year 12 Girls aged 1718 (school year 13) Questions?