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Simon Dobson BC Childrens Hospital Vaccine Evaluation Centre Child & Family Research Institute Vancouver University of British Columbia, Canada Two dose.

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Presentation on theme: "Simon Dobson BC Childrens Hospital Vaccine Evaluation Centre Child & Family Research Institute Vancouver University of British Columbia, Canada Two dose."— Presentation transcript:

1 Simon Dobson BC Childrens 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:I have carried out vaccine clinical trials for: –Merck –GlaxoSmithkline –Novartis –Sanofi Pasteur –Dynavax I have been on Advisory Boards for GlaxoSmithkline and MerckI have been on Advisory Boards for GlaxoSmithkline and Merck I have been on the National Advisory Committee on Immunization (Canada)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 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 Health The Provincial Governments of Quebec and Nova Scotia

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

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 schedules are also possible


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