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John M. Douglas, Jr., MD Denver Public Health

Strategies for Development and Implementation of Viral STD Vaccine Programs: Inventing an Effective Vaccine is Not Enough. John M. Douglas, Jr., MD Denver Public Health. Innovations in Vaccine Delivery: the 20th Century.

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John M. Douglas, Jr., MD Denver Public Health

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  1. Strategies for Development and Implementation of Viral STD Vaccine Programs: Inventing an Effective Vaccine is Not Enough John M. Douglas, Jr., MD Denver Public Health

  2. Innovations in Vaccine Delivery: the 20th Century

  3. Innovations in Vaccine delivery: the 21st Century (public health officials trying to meet teens on their own turf)

  4. Implementation of Hepatitis B Vaccine • Proven efficacious in large trials among neonates, MSM, IDU in late 70s-early 80s • Efficacy: 3 doses 95+%, 2 doses 75%, 1 dose 50% • The chronology • licensed in U.S.1982, recommended for high-risk groups • mandated for HCWs 1989 • routine infant immunization 1991 • routine for young adolescents 1994 • routine for STD clinics, 1998 • still no comprehensive older adolescent/adult program (the missed generation) in the U.S.

  5. Difficulties in Reaching the Highest Risk Groups: MSM • 3432 MSM 15-22, 7 US cities in Young Men’s Health Survey, 1994-98 • Prior immunization in 9% • Prior infection in 11% (2% in 15 yo, 17% in 22 yo) • Of susceptibles, 96% had regular source of health care or access for HIV/STD testing (MacKellar DA. AJPH 2001; 91: 965)

  6. Missed Opportunities for HBV Immunization • CDC HBV sentinel surveillance, 1996-8: • % of acute HBV cases with prior encounters • known infected contact 9% • hx STD Rx or incarceration 55%

  7. Difficulties in Targeting High-risk Adolescents/Adults • 1997 survey of 65 STD programs and 89 STD clinics • 21% of programs had HBV vaccination policies; 45% of clinics had HBV vaccine policies (mostly VFS) • Issues: funding for vaccine & resources for pre-vaccination counseling, vaccine administration, and client tracking (Wilson BC, STD 2001; 28:148)

  8. STD clinic-based HBV Immunization: the San Francisco Experience, 1990 • Willing to receive free vaccine 44% • Already exposed 28% • No. receiving HBV doses • 0 56% • 1 22% • 2 8% • 3 14% (Weinstock. AJPH 1995; 85: 846)

  9. STD clinic-based HBV Immunization: the Denver Experience, 1999-2001 • No. eligible patients 5047 • Willing to receive free vaccine 60% • No. receiving HBV doses • 0 70% (40% refused, 30% no show) • 1 15% • 2 8% • 3 7% • Overall protection 21% (Subiador, 2002 STD Conference)

  10. Age-related seroprevalence of HSV-2 and HPV-16 in the population Age HSV-2 HPV-16 12-19 5.6% 5.1% 20-29 17.2% 14.6% 30-39 27.8% 14.7% 40-49 26.6% 17.0% 50-59 25.1% 10.6% (Fleming. NEJM 1997; 337: 1105; Stone 2000 Nat STD Prevention Conf)

  11. Age-related HSV-2 seroprevalence among STD Clinic Populations (Gottlieb, data from Project RESPECT)

  12. Strategies for Reaching Persons with STD Vaccines Before Young Adulthood • Childhood immunization • Opportunistic immunization of sexually active adolescents (eg, family planning, STD clinics) • Routinely recommended immunization of pre-adolescents • primary health care providers • school-based programs

  13. Chain of vaccine program implementation • Professional organization recommendation • Infrastructure for immunization • routine well-adolescent visits • school-based clinics • Support by payors • Legislation (e.g., school entry requirements)

  14. Routine adolescent immunization (AI) visits • Recommended in 1996 by ACIP, AAP, AMA, AAFP • Intent: establish a routine visit to allow improve immunization coverage for VZV, MMR, DT, and HBV, and provide other recommended prevention services

  15. School-based clinics for adolescent immunization • Broad access/coverage: 99% of children enrolled until age 13, including those with no other sources of preventive care • Full-scale school support: • publicity through school • incentive programs • peer pressure • teacher and prinicipal support • education through health classes • organized school “vaccination days” • More effective tracking and reminders • Student & parent convenience (Middleman. J Adol Hlth 2000; 26: 320)

  16. Completion of HBV Immunization in Adolescents • Statewide targeted HBV vaccine program for 10,716 adolescents (11-18) 1996-97 in Oregon • Completion rates within the school year • school-based centers 91% • LHD outreach to schools 85% • LHD clinics 64% (Nystrom. J Adol Hlth 2000; 26:320)

  17. Middle School-based HBV Immunization: the Denver Experience, 1996-7 • Partnership with local MCOs to reimburse school clinics for HBV immunization • No. students 4543 • Consented/exempted 74%/12% • No. receiving HBV doses • 0 1% • 1 5% • 2 8% • 3 85% • More cost-effective than network HMO ($31 vs. $68/dose; not including indirect work-loss costs) (Deuson AJPH 1999; 89: 1722)

  18. Mandated HBV Immunization • Colorado school entry law • Effective August, 1997, three doses of HBV vaccine required for entry into 7th grade • In subsequent years, the law extended to 8th and then 9th grade for that cohort • Goal: In six years (May, 2003) all students between kindergarten and 12th grade will be immunized against HBV • Currently, approximately 45 states have regulations mandating HBV vaccine for school entry • Requires collaboration between state/local HD, schools, local NGOs, health care providers • May benefit from “model legislation” templates

  19. Adolescent Immunization: the trickle-up effect among Denver STD clinic patients Year History of HBV vaccine 1999 48% 2000 58% 2001 72% (Subiador, 2002 STD Prevention Conference)

  20. Other issues for STD vaccine delivery programs • Willingness of parents to consent to vaccines • Willingness of payors to cover vaccines • Willingness of boards of health to require vaccines • Willingness of school boards to allow STD vaccines in school-based clinics • Should the “STD” nature of the infections be downplayed (eg,vaccines to prevent “birth defects” or “cervical cancer”; naming issues--CIN-VAX)

  21. Thoughts for the Future “…lack of openness and mixed messages regarding sexuality create obstacles to STD prevention for the entire population and contribute to the hidden nature of STDs.” The Hidden Epidemic, 1997 Our ultimate ability to broadly immunize young adolescents against infections STD will depend on societal ability to acknowledge and discuss adolescent sexuality

  22. Implementation of STD vaccines: Issues beyond delivery systems • Role for serologic pre-screening (HSV-1 or -2, various HPV types) • Impact on disease presentation (eg, more asymptomatic and less easily recognized) • Impact on other screening programs (eg, cervical cytology) • Defining the need for booster doses

  23. Other issues for STD vaccine delivery programs • Willingness of parents to consent to vaccines • Willingness of payors to cover vaccines • Willingness of boards of health to require vaccines • Willingness of school boards to allow STD vaccines in school-based clinics

  24. Hepatitis B Vaccine: Reasons for Failure of Risk-Targeted Programs • Adult providers not vaccine-attuned • High-risk persons (and some providers) didn’t understand/care about long-term HBV consequences • High-risk groups hard to access, require risk factor elicitation, & 10-30% already infected • No payor for high-cost vaccines • Limited infrastructure to deliver 2 follow-up doses of vaccine over 6 months and limited attention to partial benefit (1 dose 50%, 2 doses 85%) • AIDS effect: attention distracted from HBV and in highest risk groups, those with ongoing risky behavior likely to contract and die of HIV before vaccine benefit realized

  25. Value of School-Based Immunization Programs • Broad access/coverage: 99% of children enrolled until age 13, including those with no other source of preventive heath care • Convenient for parents & students and can reduce costs of transportation and lost parent work time • Efficient for large MCOs to deliver contracted vaccine benefits • Vaccine programs can complement general & sexual health curriculum • May be convenient for other adolescent prevention activities

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