Update on HPV & Cervical Cancer Vaccines

Transcription

1 Update on HPV & Cervical Cancer Vaccines Women in Government: 12th Annual Southern Regional Conference Jennifer S. Smith, PhD, MPH Associate Professor, UNC Director, Cervical Cancer-Free America

2 Cervical Cancer 2011 estimates in the United States: 12,700 women diagnosed 4,300 deaths

3 Age-adjusted Mortality Rates per 100,000, SEER Data DC Age-adjusted Death Rates per 100,000 Quantile Interval ALASKA HAWAII US Rate 2.5 SEER = Surveillance, Epidemiology, and End Results 1. Surveillance, Epidemiology and End Results (SEER) Cancer Stats NCI,

4 HPV Infection and Cervical Cancer Human papillomavirus (HPV): primary cause of cervical cancer (99.7% worldwide) Over 120 HPV types identified, >40 types infect the genital tract types classified as high-risk (HR) (oncogenic) types Cogliano et al. Lancet Oncol. 2005;6:204.

5 HPV infection common toall humanity Every person has at least one HPV infection 70-80%have had an anogenital infection at some time in their lives

6 HPV DNA % % HPV DNA % by stage of cervical neoplasia (Herrero et al., J Nat Cancer Inst) 20.3% 72.9 % Normal Ascus Low-CIN High-CIN Invasive Cancer 88.8% >95%

7 Natural History of HPV/ Cervical Neoplasia HPV Infection Transient Infections Persistent Infection Low Grade SIL (HPV/ CIN I) Low Grade SIL (HPV/ CIN I) High Grade SIL (CIN II/III) Invasive Cancer HPV types and variants Host factors: Genetic susceptibility Immunological factors HIV, HSV-2 and C trachomatis Hormonal factors Long-term oral contraceptive use High parity Tobacco smoking Screening/treatment

8 Bivalent Vaccine Studies 001 & 007 Sustained Protection up to 4.5 years Vaccine efficacy (%) HPV 16 and 18 associated diesease % 100% 100% 93% 0/6 Incident Infection ATP ATP ATP ITT ITT 6M Persistent Infx Initial efficacy study (001) 12M Persistent Infx post hoc 95% 96% 100% 96% 100% ATP ATP ATP ITT ITT Cytology 001 / 007 combined analyses CIN Figure based on Harper et al. Lancet. 2004; 364: 1757 Harper et al. Lancet. 2006; 367 : 124.

9 Analysis of Quadrivalent Prophylactic Efficacy Against HPV 6, 11, 16, or 18-Related External Anogenital or Vaginal Lesions (EGL) Subjects Previously Exposed to 1 Vaccine HPV Type at Day 1 Vaccine (N = 8,799) Placebo (N = 8,800) HPV 6,11,16,18- Related EGL By HPV Type n Number of cases Rate* n Number of cases Rate* Observed efficacy 95% CI 2, , % (71.1, 98.2) HPV 6-Related 1, , % (59.4, 97.6) HPV 11-Related 1, , % (15.7, 100.0) HPV 16-Related % (<0.0, 100.0) HPV 18-Related 1, , % (<0.0, 100.0) Subjects are counted once in each applicable endpoint category. A subject may appear in more than one category. *Cases per 100 person years at risk. N = Number of subjects randomized to the respective vaccination group who received at least 1 injection and were seronegativeand PCR negative to the relevant HPV type at enrollment; n = Number of subjects in the given population with at least 1 follow-up visit following 30 days after Day 1; VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia.

10 Cervical Cancer Prevention in Women Primary prevention to reduce the genital acquisition of HPV infection: Prophylactic HPV vaccines Secondary prevention: Screening and treatment of cervical cancer lesions (Cytology, HPV Detection)

11 Carolina Framework for Action against Cervical Cancer The Framework identifies four main causes of cervical cancer. 100% HPV infection 54% Not screening 29% Screening errors 12% Not completing treatment

12 HPV Vaccine HPV vaccine can prevent most infections Safe & highly effective Covered by private insurance and VFC

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14 HPV virus-like particles (VLPs) Recombinant L1 Proteins Self-assemble Assemble as pseudoviral particles Not infectious Intramuscular Injection For Prevention of : Persistent infections Abnormal cytology HPV-16/18 associated lesions

15 Two HPV VLP Vaccines GlaxoSmithKline: HPV16 Bivalent HPV18 ASO4 Adjuvant (Aluminum + MPL) Made in insect cells 70% of Cervical Cancer Merck: Bivalent HPV16 70% of Cervical Cancer HPV18 HPV6 90% of Genital Warts HPV11 Aluminum Adjuvant Made in yeast IM Injections at 0, 1 or 2, and 6/7 months

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17 HPV Vaccine Uptake In Australia and UK: ~80% In the US: ~35% Relatively low vaccination uptake.

18 Cervical Cancer Free America Mission To end or substantially reduce cervical cancer in the United States.

19 CCFA Goals To increase HPV vaccination among young female adolescents ages To increase cervical cancer screening among women ages who have not been screened in the last four years.

20 Healthcare Reform in the US US healthcare reform provisions expand preventive services and will increase our ability to become cervical cancer-free. Screening Vaccination Medicaid Access to prevention and care will be limited to US citizens.

21 CCFA State Partners = 30% of all cervical cancer cases in United States Puerto Rico

22 University of Alabama Warner Huh, Mona Fouad Hosted first Health and Economics Summit Initiated peer educator and technology-based health education programs Will assess marketing campaign and school initiative to increase vaccine uptake

23 CCF-Alabama Projects REACH US A well-established and diverse coalition aims to use direct action organizing principles to educate and mobilize community stakeholders to advocate for public policy changes that enhance cervical cancer screening and HPV awareness. Teen CHA The goal is to reduce high-risk health behaviors including those associated with HPV acquisition and increase HPV vaccination rates among adolescents by using peer health educators. Health-e-Teen

24 Health-e-Teen Model Teen Council Text Messaging Website Experts Panel

25 University of Kentucky Baretta Casey, Rick Crosby Pap Campaign Competitive call for proposals award for creative ideas to fight cervical cancer Will develop provider training through rural health prev. network

26 FY 2012 Mini-Award Projects 1 September June proposals; 13 mini-awards ranging from $7,000-$20,000 serving 19 counties: 1. Barren River Women's Health Screening Project Barren River District Health Department 2. Cervical Cancer Health Education Program Bullitt County Health Department 3. Cervical Cancer-Free Begins With Me Calloway County Health Department 4. Cumberland Valley District Cancer Coalition Cumberland Valley District Health Department 5. Spread the Word, Not the Disease Greenup County Health Department 6. KSU Thorobreds Trotting on HPV and Cervical Cancer KDPH Office of Health Equity 7. HPV- Not Just for Women Knox County Health Department 8. Using School-Based Health Clinics to Increase HPV Vaccination Rates Lake Cumberland District Health Department 9. Cervical Cancer Prevention Project: Help, Protect, Vaccinate Lawrence County Health Department 10. Cervical Cancer Free Kentucky Lewis County Health Department 11. "Save the Date" for Cervical Cancer Prevention Madison County Health Department 12. Cervical Cancer Prevention: Attention Prevention II Magoffin County Health Department 13. Montgomery Co. Cervical Cancer Project Montgomery County Health Department

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28 Cervical Cancer-Free NC Launched January 2010 UNC staff Noel Brewer, Director Jennifer Smith, Co-Director Pamela Entzel, Program Manager Ashley Leighton, Project Coordinator Generous funding provided by GSK

29 School Health Center Projects Survey of NC school health centers (SHCs) 33 of 55 centers stock HPV Adolescent vaccination intervention 4 high schools Improved consent form, materials Incentive for returning consent form Process and outcome evaluation

30 Lessons Learned SHCs interested in partnering on interventions SHCs varied in terms of: Enrollment Consent procedures Ability to accept private insurance Vaccination activities Interventions must be flexible

31 Other Projects Online resource directory NC Immunization Branch intervention evaluation Monitoring HPV vaccine uptake in NC NC Breast and Cervical Cancer Control Program provider interviews More at

32 Together we can reduce or eliminate cervical cancer.

33 Stakeholders Communities Parents, adolescents Cervical cancer survivors Minority and religious leaders Public Health Division of PH Local health departments Health Care Providers OBGYNs, Pediatricians, Physicians, nurses, PAs, NPs Pharmacists Community health centers Cancer centers, hospitals Legislators Schools School-based health centers School administration Private sector Insurers Employers Vaccine and test makers Researchers, Non-profits. And many, many other important stakeholders!

34 Find CCFA online Facebook: Twitter: CCFA Clearinghouse: Contact:

35 Thank you!

36 RWJF Preliminary Work Self-administered Survey (n=500) 10 public schools in the Greater Birmingham area 250 middle and 250 high school students Demographics 90% African American 50% male, 50% female years of age Strongest media habits are TV, internet, and text messaging

37 Survey Data 30% of middle-school students reported having sex 81% of those reported condom use the most recent time 74% of high school students reported having sex 63% of those reported condom use during the most recent time 40% of middle school students indicated that the HPV is the same as HIV/AIDS 62% indicated that no one had talked to them about HPV 60% were not aware of the vaccine Sexual initiation age for majority of teens

38 Health-e-Teen in Alabama Developed based on preliminary work conducted by RWJF Scholars Goal: Assess the feasibility of using CBPR approach to develop an interactive website, with opt-in text messaging capability, focused on adolescent reproductive health Purpose of the website and text messages are to increase: STI and HPV knowledge Perceived severity of STIs and HPV infection/cancer risk Perceived susceptibility to STIs and HPV infection Willingness to receive HPV vaccination

39 Health-e-Teen Model Teen Council Text Messaging Website Experts Panel

40 Planned Activities Series of group discussions (15-20) Provide input for the content and layout of the website and text message scripts Focus on, but not limited to, sexual risk behavior and STI prevention (including information on HPV infection and vaccination) Develop action plan for promotion and dissemination of website and text messages 40

41 University of Alabama REACH at Birmingham (UAB) US Collaborators Mona Fouad, MD, MPH, Division of Preventive Medicine and MHRC Warner Huh, MD, Division of Gynecologic Oncology Theresa Wynn, PhD, Division of Preventive Medicine Maria Norena, Division of Preventive Medicine Amber Anderson, Division of Preventive Medicine Partners Mrs. Rosa Posey National Black Church Family Council Norwood Resource Center B&D Cancer Care Center National Dunbar Abrams SISTAs Can Survive Friends of West End Alabama Breast and Cervical Cancer Coalition UAB Minority Health & Health Disparities Research Center Alabama Department of Public Health American Cancer Society UAB Comprehensive Cancer Center Alabama National Breast and Cervical Cancer Early Detection Program 41

42 Program Collaborators University of Alabama at Birmingham (UAB) Mona Fouad, MD, MPH, Division of Preventive Medicine and MHRC Tina Simpson, MD, MPH, Department of Pediatrics Yu-Mei Schoenberger, PhD, MPH, Division of Preventive Medicine Allison Litton, DrPH, Division of Preventive Medicine Renee Desmond, PhD, Division of Preventive Medicine Mirjam Colette-Kempf, PhD, MPH, School of Nursing UAB Minority Health and Health Disparities Research Center Joanice Thompson Maria Norena Birmingham City School System 42

43 UAB Mona Fouad, MD, MPH, Division of Preventive Medicine and MHRC Yu-Mei Schoenberger, PhD, MPH, Division of Preventive Medicine Tina Simpson, MD, MPH, Department of Pediatrics Allison Litton, DrPH, Division of Preventive Medicine Renee Desmond, PhD, Division of Preventive Medicine Mirjam Colette-Kempf, PhD, MPH, School of Nursing Omar Mohiuddin, MPH, Division of Preventive Medicine UAB Minority Health and Health Disparities Research Center Joanice Thompson Maria Norena RWJF Scholars Maria Norena, UAB MHRC Sharon Elam, S.A.F.E. Place, Inc. Julie Beckham, Level-Up Jeralyn Powell, Media for Health Birmingham City School System Program Collaborators 43