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Two dose Q-HPV Vaccine Study

Simon Dobson BC Children ’ s Hospital Vaccine Evaluation Centre Child & Family Research Institute Vancouver University of British Columbia, Canada. Two dose Q-HPV Vaccine Study. Disclosures. I have carried out vaccine clinical trials for: Merck GlaxoSmithkline Novartis Sanofi Pasteur

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Two dose Q-HPV Vaccine Study

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  1. Simon Dobson BC Children’s Hospital Vaccine Evaluation Centre Child & Family Research Institute Vancouver University of British Columbia, Canada Two dose Q-HPV Vaccine Study

  2. Disclosures • I have carried out vaccine clinical trials for: • Merck • GlaxoSmithkline • Novartis • Sanofi Pasteur • Dynavax • I have been on Advisory Boards for GlaxoSmithklineand Merck • I have been on the National Advisory Committee on Immunization (Canada)

  3. Why do this study? • Cervical cancer is second most common cancer in women worldwide (500,000 per year) • HPV vaccines offer the opportunity of primary prevention • Barriers are vaccine cost and accessibility

  4. Why do this study? • Pre-licensure studies showed that 9-13 year olds responded better to the vaccine than 16-26 year olds • Would it be possible to use this better response as an opportunity to use two instead of three doses?

  5. Study Funded by:British Columbia Ministry of HealthThe Provincial Governments of Quebec and Nova Scotia

  6. Trial design 2 dose versus 3 dose HPV vaccine study: a phase III post licensure randomized controlled trial Sample Size N=825 Study group 1 9-13 year olds females N=260 Study group 2 9-13 year old females N=260 Study group 3 16-26 year olds females N=305 Study arm, Gardasil™ 0 and 6 months Control arms, Gardasil™ 0, 2 and 6 months Primary outcome: Anti-HPV 16 and 18 GMT, t = 7 months 6

  7. Primary Endpoints Differences in Geometric Mean Titres (GMT) of antibodies to HPV 16 and HPV 18 at Month 7 Non-inferiority will be declared if lower bounds of the adjusted 95% CI of GMT ratios for HPV 16 and HPV 18 are greater than 0.5

  8. Geometric Mean Titres in the Intention To Treat Population Dobson S et al. JAMA 2013

  9. GMT Ratios in the Intention To Treat Population Dobson s et al. JAMA 2013

  10. Conclusions Following a 2 dose regimen in 9-13 year old girls, antibody responses to HPV-16,-18,-6,-11 were non-inferior through 36 months, as compared to a 3-dose regimen in young adult women

  11. GMT Ratios in the Intention To Treat Population Dobson s et al. JAMA 2013

  12. Why is this important? • Better use of resources • Protects more girls • Worldwide, saves lives

  13. But….. Still need answers to two questions: • What is the duration of protection? • This is known for neither 3 doses nor 2 doses…yet • Does 2 doses work as well as 3 doses? • A Canadian study has started Extended 2 + 1 schedules are also possible

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