HPV Vaccine: Signature Project

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HPV Vaccine Signature Project

• Roshan Bastani, PhD Jennifer Allen, PhD
• National CPCRN Meeting
• Boston, MA
• Nov 1-2, 2007

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Licensed Candidate Prophylactic HPV Vaccines
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GARDASIL Efficacy

• Per-protocol Efficacy (98-100)
• Efficacy in reducing HPV 6,11,16,18 related
  disease in unexposed
• Intent-to-treat Efficacy (44-73)
• Impact in reducing disease from HPV 6,11,16,18 in
  all those vaccinated
• General Population Impact (17-34)
• Impact in reducing all disease (regardless of HPV
  type)

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Remaining Unanswered Questions

• Long term safety
• Extent of immunity
• Cross protection vs. type replacement
• Pre/post sexual debut
• Male vaccination
• Impact on cervical cancer deaths will not be
  apparent for long time
• Comparison to other HPV vaccines

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Attitudes and Knowledge

• General lack of knowledge about HPV
• Low perception of risk
• Mistrust of vaccine
• Both are likely to impair demand for vaccine
• Will require public educational efforts to raise
  awareness
• Implementation of policy and other interventions
  to increase utilization

Dempsey et al, Am Jour of Mgd Care, 2006 Dec
12(17 Suppl)
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Challenges with Adolescent Vaccination

• Adolescents less likely to seek care
• No established preventive care visits
• Acute/emergent care
• Physicals for school/athletics
• More likely to be uninsured

Dempsey et al, Am Jour of Mgd Care, 2006 Dec
12(17 Suppl)
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Gardasil Costs

• Most expensive recommended vaccine introduced to
  date
• 120/dose private
• 96.75/dose public
• Has complicated already strained vaccine
  financing system

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Federal Contract Prices for Vaccines Recommended
Universally for Children and Adolescents 1985,
1995, 2006
1185
894
155
45
Federal contract price shown for 1985 and 1995
are averages that account for price changes
within that year.
Source Anne Schuchat, CDC
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Vaccine Financing

• Vaccines for Children (VFC) Program
• Federal 317 funding
• State funding
• Private funding
• Manufacturer assistance programs

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Current NCI Portfolio

• About 8 currently funded projects, R15, R01, R03,
  R21, R43/44
• KAB Surveys parents, women, physicians
• Decision making re vaccinating girls among
  parents
• Dev low literacy audio-visual materials for
  parents
• F/U of abnormals
• Feasibility and efficacy of self-sampling vs in
  clinic sample

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Possible CPCRN Projects

• Compile existing instruments, develop a minimal
  set of standard items
• Gather existing education/intervention materials
  and protocols
• Conduct surveys physicians, parents, youth,
  college, adults
• Develop decision tools providers, parents, women
• Conduct interventions across sites
• policy access, coverage, mandates
• organizational level, individual level, provider,
  women
• Technical assistance to CBOs

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QuestionsPeople Have

• Will GARDASIL help if already have HPV?
• Does one still have to get PAP Tests if
  vaccinate?
• Who is going to pay for the vaccine? How much
  does it cost?
• What are the benefits and harms of the vaccine?
• How long do the benefits and harms last?

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QuestionsPeople Have

• Why should my daughter be vaccinated at age 11 or
  12? She's not sexually active. Can't we wait?
• Does the vaccine send a message that it's okay to
  have sex and therefore encourage or lead to
  increased sexual activity?

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What do parents really think?

• Unfamiliar with HPV
• Ive never heard of it. Ive heard of syphilis,
  gonorrhea. Ive heard of genital warts, Ive
  heard of herpes. Are any of these considered in
  the HPV family?
• Information sheet-- changed knowledge, but not
  acceptability of HPV vaccine
• Risk of acquiring HPV
• This is somewhat different vaccine than tetanus
  and chickenpox HPV is preventable by not having
  sex, not being promiscuous.
• Age of HPV vaccine administration
• Greater vaccine acceptability at older age
  groups

Olshen, et. al., 2005 Dempsey, et al. 2006