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Human Papillomavirus and HPV Vaccine

Human Papillomavirus and HPV Vaccine. Charlene Graves, M.D. Medical Director, Immunization Program, ISDH Chgraves@isdh.in.gov (317) 233-7164 October 2007. HPV (Human Papillomavirus) Disease . Infection Cancer Virus is species-specific HPV types are usually body site-specific

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Human Papillomavirus and HPV Vaccine

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  1. Human Papillomavirus and HPV Vaccine Charlene Graves, M.D. Medical Director, Immunization Program, ISDH Chgraves@isdh.in.gov (317) 233-7164 October 2007

  2. HPV (Human Papillomavirus) Disease • Infection • Cancer • Virus is species-specific • HPV types are usually body site-specific • Skin-to-skin transmission of infection

  3. HPV – The Most Common STI • In the U.S., 6.2 million people are newly infected each year • Estimated that 80%+ of sexually active women will have acquired genital HPV by age 50 • What about men? Heterosexual men – prevalence of HPV infection was 20%+ (influence of sampling site and how specimens are collected)

  4. HPV Background • Small DNA virus • Inserts into human DNA by process termed INTEGRATION • HPV on skin and mucosal surfaces • Not in body fluids (different from Hepatitis B virus) • RESIDENTIAL infection – basal epithelium of skin, inactive there. Some trigger then promotes viral replication, ascends to top layer

  5. Immunology of HPV • Shielded from the host immune response because resides in the skin epithelium • Not all infected persons have antibodies • One study showed that 54%-69% of infected women had antibodies

  6. HPV Characteristics • > 100 types identified • 40+ are anogenital • Oncogenic types • 16, 18: 70% of cervic. CA • Non-oncogenic types • 6, 11 for genital warts • 90% of genital warts

  7. Laboratory Testing for HPV • Cannot culture for HPV • DNA assays vary in sensitivity and type specificity • Digene Hybrid Capture 2 (HC2) High-Risk DNA Test approved by the FDA for use in women • Serologies only for research – VLP-based enzyme immunoassays.

  8. HPV DNA Testing - NOT • A. for men • B. to check for HPV in genital warts/other STIs • C. to check for HPV in partners of B • D. to check for HPV in partners of women with pre-cancerous lesions • E. to check for HPV in pregnant women

  9. Oncogenic Types re Cervical Cancer • Most significant risk factor in etiology of cervical cancer • Prevalence of HPV DNA in cervical cancers worldwide = 99.7% • Specific oncogenic HPV types detected in 63%-97% of invasive cervical cancer cases worldwide • Types 6 & ll in 80% of anal cancers and 40% of vulvar cancers

  10. Impact of HPV in Adolescents & Young Adults in the U.S. • 74% of infections in 15-24 year olds (1 in 4 of all in that age group) • Lifetime risk for sexually active men and women is at least 50% • Estimated lifetime risk for genital warts is about 10% • Other anogenital cancers • Also oropharyngeal cancers

  11. ACS & ACOG Guidelines for Cervical Cancer Screening in Adolescents • Should begin about 3 years after onset of intercourse but no later than 21 years of age • May start earlier - based on time course in progression of CIN and unpredictable F/U in young women • Pap smear screening each year (or every 2 years if liquid based) to age 30

  12. Burden of Disease – Cervical Cancer in the U.S. • 50%+ of sexually active persons will acquire a genital HPV in their lifetime • U.S. – about 12,200 cases and 4,100 deaths in 2003 • U.S. – 300,000 cases of high-grade dysplasia • Indiana – about 1,000 women newly diagnosed, 300+ deaths

  13. Cervical Cancer - Worldwide • 2nd leading cause of female cancer-related deaths (1 in 20) • 288,000 deaths each year • 510,000 NEW cases each year

  14. U.S. - Progress in Cervical Cancer • 75% decline in rates since Pap testing introduced in U.S. • 83% of women had Pap test within the past 3 years • Over 50% of cervical CA cases in women who rarely/never have Pap test • Projected cases for 2006: 9,700 new, 3,700 deaths

  15. Natural History of HPV Infection and Potential Progression to Cervical Cancer1 0–1 Year 1–20 Years 0–5 Years Invasive Cervical Cancer InitialHPV Infection ContinuingInfection CIN 2/3 CIN 1 Cleared HPV Infection 1. Pinto AP, Crum CP. Clin Obstet Gynecol. 2000;43:352–362.

  16. HPV Transmission and Acquisition • Nonsexual routes • Rare mother to newborn • Hypothesized –fomites, clothing • Sexual contact • Through sexual intercourse • Genital-genital, manual-genital, oral-genital not as common modes of transmission • Condom use may reduce risk, but it is not fully protective

  17. Cumulative Incidence of HPV Infection Months Since First Intercourse Infection From Time of First Sexual Intercourse Study of female college students (N=603) From Winer RL, Lee S-K, Hughes JP, Adam DE, Kiviat NB, Koutsky LA. Genital human papillomavirus infection: Incidence and risk factors in a cohort of female university students. Am J Epidemiol. 2003;157:218–226, by permission of Oxford University Press.

  18. Natural History - HPV Clearance • Women 15-25 years of age – 80% of HPV infections are transient • Study of 608 college women – 70% of new infections cleared within 1 year, 90% within 2 years • Certain HPV types are more likely to persist (e.g., types 16 & 18)

  19. Treatment of HPV Infection • Cannot be DIRECTLY treated • Only HPV-associated lesions can be treated • Options: cryotherapy, electrocautery, laser therapy, and surgical excision • Genital warts – topical agents • Treatment might reduce infectiousness

  20. HPV Persistence • Persistent infection: Detection of same HPV type 2 or more times over several months to 1 year • Crucial for development of cervical pre-cancer and cancer • Other factors • Age >/= 30 years • Infection with multiple HPV types • Immune suppression

  21. HPV Vaccine Strategies • Vaccinate before onset of sexual activity • Vaccinate both males and females • Immune response strongest at youngest ages • Unknowns: • What antibody titers are protective • How long protection will last • Getting vaccine to women rarely tested for cervical cancer

  22. Sexual Activity Factors re HPV • Infections acquired soon after sexual activity begins • 16 months later – 40% infected • YBRSS (2003) sexual activity: • 7% by age 13 • 1/3 by 9th grade • 2/3 by high school graduation

  23. Gardisil (Merck) • FDA licensed on June 8, 2006 • Quadrivalent vaccine (types 6, 11, 16, 18). $300-$500 cost for series • Licensed for females 9–26 years • Nearly 100% efficacy for warts, Pap changes, infection • Intramuscular injections –at starting age, then 2 months & 6 months later

  24. More on Gardisil re ACIP • Review of data from clinical trials – 11,000 females age 9-26 years • Review of cost effectiveness studies • Plans for post-licensure safety monitoring • ACIP recommendations for use of vaccine as of June 29, 2006

  25. ACIP Recommendations • Routine immunization of females 11-12 years of age • “Catch-up” for females 13-26 years not previously vaccinated • Ideally, vaccinate before sexual activity • Pap test, HPV DNA, HPV antibody NOT recommended before vaccination • No change in cervical cancer screening recommendations

  26. Vaccine Safety • No serious adverse events in clinical trials • VAERS – local reactions, fainting • Guillain-Barre Syndrome – 3 reports, not out of proportion • 5 million doses distributed as of June 2007

  27. Vaccine Unknowns • Immune memory appears strong • Need for booster shots? • Cross-reactivity to protect against other HPV types • Safety in pregnancy – registry maintained by Merck

  28. Special Situations: Already HPV Infected • Vaccination still of some benefit to prevent acquisition of some HPV types • If known genital warts, abnormal Pap or HPV DNA +, vaccination recommended • Vaccine will NOT protect from disease related to HPV types involved in current infection • Vaccine will not affect existing cervical lesions or infections (it is not therapeutic)

  29. Cervarix (GSK) • Not yet FDA licensed – submit late 2006 • IM dosing -at starting age, then 1 and 6 months later • Bivalent vaccine (types 16, 18) • Tested in 15-25 year olds • Prevented Pap smear changes in 68%

  30. Indiana Legislation re HPV • Senate Bill 327 of 2007 introduced by Senator Connie Lawson • Initially, mandated vaccine for all 6th grade girls • Revised to mandate education for all 6th grade girls • ISDH role – develop educational information

  31. Indiana Legislation, continued • Also a parent response form to be returned to the school (starts 2008) • Responses available: • Plan to have vaccinated • Do not plan to have vaccinated • Choose not to answer the question • In 2008, aggregate reporting of data to ISDH

  32. Vaccine Availability • Vaccines for Children (VFC) • Private health insurance • Title X Clinics • If had been mandated for all 6th grade girls, $2.67 million of state funding would have been needed

  33. Questions?

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