Recent Findings From The NCI Costa Rica HPV-16/18 Vaccine .
Recent findings from the NCI CostaRica HPV-16/18 Vaccine TrialAimée R. Kreimer, Ph.D.InvestigatorInfections and Immunoepidemiology BranchDivision of Cancer Epidemiology and GeneticsNational Cancer Institutekreimera@mail.nih.gov
Cervical Cancer Worldwide incidence and mortality– 500,000 new cases per year– 250,000 deaths per year Incidence and survival rates vary bygeographical region– 85% occur in developing nations HPV is a necessary cause of cervical cancer
HPV-associated cancers: US100Percent of Cancer Cases806040200CervixAnusPenisVaginaVulvaTonsil Oral Cavity
HPV-associated cancers: US100Incidence increasing over timePercent of Cancer Cases806040200CervixAnusPenisVaginaVulvaTonsil Oral Cavity
Estimated burden of HPVassociated cancersCancer 28,000611,51074,160UNITED 4,5406,170
Estimated burden of HPVassociated cancersCancer 28,000611,51074,160UNITED 4,5406,170
Two prophylactic HPV VaccinesManufacturerHPV Types Included inVaccineGlaxo Smith Kline HPV 16HPV 18CervarixMerckGardasilHPV 16HPV 18HPV 6HPV 1170% ofCervicalCancer90%ofGenital WartsUS FDA LicensureFemales ages 10-25 for theprevention of cervical diseaseFemales ages 9-26 for theprevention of cervical, vulvar,vaginal, and anal disease90% ofGenital Warts Males ages 9-26 for theprevention of genital wartsand anal disease
Use of the vaccine Advisory Committee on ImmunizationPractices of the Centers for Disease Controland Prevention HPV vaccine recommended for:– Females- ages 11-12; range: 9 to 26 years– Males- ages 11-12 with the quadrivalent vaccine; Recommended range: 9 to 21 years Permissive range: 22 to 26 years
Both HPV vaccines prevent cervical HPVinfections among uninfected young women100%94%96%MerckGSK91%90%Vaccine Efficacy (%)80%70%60%50%40%30%20%10%0%Villa LL et al. BMJ 2006; Paavonen J et al. Lancet 2009Costa Rica
Findings from our vaccine trial confirmreports from commercial trials100%94%96%MerckGSK91%90%Vaccine Efficacy (%)80%70%60%50%40%30%20%10%0%Costa RicaVilla LL et al. BMJ 2006; Paavonen J et al Lancet 2009; Herrero R et al Cancer Discovery 2011
NCI findings from the CostaRica Vaccine Trial1. No therapeutic efficacy of the prophylacticHPV vaccine2. Vaccine safety profile is comparable toother licensed vaccines– Not recommended during pregnancy3. High vaccine efficacy for HPV16/18 as wellas non-vaccine HPV types– Vaccine impact highest when vaccination isgiven at younger ages, prior to sexual initiation1) Hildesheim A. et al. JAMA 2007 2) Wacholder S. BMJ 2009 3) Herrero R.Cancer Discovery 2011
Recent Findings from NCI1. Vaccine efficacy of fewer than 3 doses2. Vaccine efficacy at other anatomic sites
Costa Rica Vaccine TrialDesign of the TrialHPV Vaccine: Virus-like particle
Costa Rica Vaccine TrialA community-based, randomized trialCENSUS7,466 Women 18-25 yoEnrolled (06/04 – 12/05)HPV-16/18 VaccineVaccine Dose 1Vaccine Dose 1Vaccine Dose 2Vaccine Dose 2Vaccine Dose 3Vaccine Dose 36 MonthsCOMPLETEDHepatitis A Vaccine
Costa Rica Vaccine Trial7,466 Women18-25 years oldHepatitis A VaccineHPV-16/18 Vaccine Annual follow-up visits for 4 years Cervical samples collected at all visits Anal and oral specimens collected at 4year visit
Long-term follow-up of the Costa Rica VaccineTrial10 total years of follow-up4 yearsHPV-16/18 Vaccine6 yearsHepatitis A VaccineON-GOINGCOMPLETED7,466 Women18-25 years old
Vaccine efficacy by doses received# ofDosesArm# of Women# of 8 VE (95%CI)80.9% (71.1% to 87.7%)HPV2957Kreimer AR et al JNCI September 201125
Vaccine efficacy by doses received# ofDosesArm# of Women# of 8 VE (95%CI)80.9% (71.1% to 87.7%)HPV2957Kreimer AR et al JNCI September 201125
Vaccine efficacy by doses received# ofDosesArm# of Women# of 8 VE (95%CI)80.9% (71.1% to 87.7%)HPV295725Control38017284.1% (50.2% to 96.3%)HPV422Kreimer AR et al JNCI September 20113
Vaccine efficacy by doses received# ofDosesArm# of Women# of 8 VE (95%CI)80.9% (71.1% to 87.7%)HPV295725Control38017284.1% (50.2% to 96.3%)HPV4223Control188101100% (66.5% to 100%)HPV196Kreimer AR et al JNCI September 20110
Conclusions After 4 years, the HPV vaccine provides highefficacy regardless of the number of dosesreceived A simpler, more affordable vaccinationschedule might be feasible
Important Questions Remain– Will these results apply to other populations?– Will these results apply to other vaccineformulations?– What is the minimum antibody level requiredfor protection?– What is the duration of protection for 3doses?
Vaccine efficacy at otheranatomic sitesHPV Vaccine: Virus-like particle
Vaccine efficacy among womenwithout 16/18 VE (95%CI)83.6% (66.7% to 92.8%)Control98648Kreimer AR et al Lancet Oncology September 2011
Vaccine efficacy among womenwithout 16/18 VE (95%CI)83.6% (66.7% to 92.8%)Control98648HPV100310Cervix87.9% (77.4% to 94.0%)Control98681Kreimer AR et al Lancet Oncology September 2011
Conclusions HPV vaccine strongly protects against analHPV16/18 infections in womenProtection is comparable to that observedat the cervixWomen who receive the HPV vaccine willhave less anal HPV infection
Upcoming research and futuredirections1. Oral HPV16/18 vaccine efficacy2. Long-term impact of vaccination–––Duration of protectionScreeningSafety3. Immunological markers of protection4. Natural history of HPV infection in avaccinated cohort
Summary of recent findings1. Confirmed that the bivalent HPV vaccine ishighly effective in the prevention of cervicalHPV infection2. Raised the possibility that only two, or maybeeven a single dose, of the HPV vaccine maybe necessary3. Demonstrated the vaccine protects at anadditional anatomic site where HPV is knownto cause cancer
AcknowledgementsNCI, US–––––Allan Hildesheim (IIB)Hormuzd Katki (BB)Doug Lowy (CCR)Ligia Pinto (IIB-SAIC)Mahboobeh Safaeian (IIB)–––––Mark Schiffman (CGB)John Schiller (CCR)Mark Sherman (HREB)Diane Solomon (DCP)Sholom Wacholder (BB)Proyecto Epidemiologico Guanacaste, Costa Rica– Paula Gonzalez– Rolando Herrero– Silvia Jimenez– Carolina Porras– Ana Cecilia RodriguezOther Groups– Julie Buckland (IMS)– Jean Cyr (IMS)– Mary Sidawy (Georgetown)– Wim Quint (DDL)– LJ van Doorn (DDL)
Costa Rica Vaccine Trial A community-based, randomized trial 7,466 Women 18-25 yo Enrolled (06/04 – 12/05) Hepatitis A Vaccine HPV-16/18 Vaccine Vaccine Dose 1 Vaccine Dose 2 Vaccine Dose 3 Vaccine Dose 1 Vaccine Dose 2 Vaccine Dose 3 6 Months COMPLETED CENSUS
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