# Presentation: 086530

## 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

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

## 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.

## 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)

## 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%

## 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)

## 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)

## 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)

## 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)

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

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

## 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

## 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)

## 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

## 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)

## 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)

## 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)

## 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

## 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)

## 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)

## 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

## 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

## 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

## 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

## 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