Two dose Q-HPV Vaccine Study

Slides:

Advertisements

Similar presentations

The Future is Now: Understanding the HPV Vaccine Guidelines E.J. Mayeaux, Jr., M.D. Professor of Family Medicine Professor of Obstetrics and Gynecology.

Advertisements

FDA/Industry Statistics Workshop 2005 Parallel Session 6: Vaccine Trials 10:10 am – 11:30 am, Sept. 16, 2005.

Overview of HPV vaccination Training GardasilTM

The Evolving Adult Immunization Platform

Barry S. Lachman, MD, MPH Medical Director 11/4/2011.

Sample & Assay Technologies For Internal Use Only QIAGEN: Making Improvements in Life Possible Improving the lives of women around the world by expanding.

Duration of Serum Antibody Response to Seasonal Influenza Vaccines: Summary The level of antibody response made to seasonal influenza vaccines depends.

Instituto Nacional de Salud Pública The Oportunidades Human Development Program: lessons learned José E. Urquieta Tegucigalpa, Honduras October 09, 2006.

Influenza and Shingles Vaccines August 2013

Group 3 – Michael, Elani, Golshan, Sarah, Joseph, Nana

Mark Jit Modelling and Economics Unit Health Protection Agency, London Case study: Structural uncertainty in human papillomavirus vaccination modelling.

Immunisation If you understand basic immunology you can explain... How vaccines work and why vaccine failures occur Adverse events and their.

HPV-vaccines – a breakthrough in medicine Björn Strander Onkologiskt centrum Västra regionen and Kungsbacka Närsjukhus Sweden.

Preliminary Key Findings Zambia Demographic and Health Survey.

HPV Vaccines: What We Know and What We Should Expect Laura Koutsky, PhD Professor of Epidemiology University of Washington Seattle, WA.

. Have you ever wondered & ask your self if there is a certain vaccine capable of protecting against cancer?!

AMMI Canada /CPHA Co-developed Accredited Learning Activity December 3, 2014 Dat Tran, MD, MSc Staff Physician, Division of Infectious Diseases The Hospital.

Rotavirus vaccines Contentious issues and the way forward.

2014 UPDATES FROM THE CDC’S ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) William Schaffner, MD Professor of Preventive Medicine and Infectious Diseases.

HPV Vaccine Update Eileen Yamada, MD, MPH Immunization Branch California Department of Health Services.

HPV and Cervical Cancer

National Vaccine Advisory Committee November 29, 2005 Update on NIH H5N1 Vaccine Trials Linda C. Lambert Chief, Respiratory Diseases Branch Division of.

The HPV Vaccine: Protecting Girls from Cervical Cancer

The HPV Vaccine Our Best Shot to Prevent Cervical Cancer Harold C. Wiesenfeld, MD,CM Department of Obstetrics, Gynecology and Reproductive Sciences-University.

Cervical Cancer and HPV

What is HPV? Estimated to be the most common sexually transmitted infection in the United States.

Anticipated impact on HPV infection from HPV vaccination programs – cause for optimism Dr Paddy Horner.

Cervical Cancer By:Marisela Esparza. Cervical Cancer is cancer in the cervix (the lower part of the cervix that connects to the vagina.)

Testing People Scientifically.  Clinical trials are research studies in which people help doctors and researchers find ways to improve health care. Each.

Moving towards universal varicella vaccination: the German experience P. Wutzler Jena, Germany Friedrich Schiller University, Jena, Germany Institute of.

HPV Related Disease Ginny Ryan. What Is HPV? The human papillomavirus is the most common sexually transmitted infection in the U.S. – 79 million Americans.

Better Health. No Hassles. Get Immunized! National Immunization Month.

1 HPV Vaccine Extended Dosing Schedule for Grade 6 September 2010.

1 HPV Vaccine Extended Dosing Schedule for Grade 6 September 2010 Revised December 2010.

1 HPV Vaccine Extended Dosing Schedule for Grade 6 September 2010 Revised December 2010.

The New HPV Vaccine Laura Zakowski, MD No conflicts of interest.

The HPV Vaccine: Protecting Your Daughter from Cervical Cancer Your questions deserve trusted answers.

. A Randomized Clinical Trial of Immunization With Combined Hepatitis A and B Versus Hepatitis B Alone for Hepatitis B Seroprotection in Hemodialysis Patients.

VRBPAC Topic #2: Clinical Development of Influenza Vaccines for Pre-pandemic Use Joseph G. Toerner, MD, MPH VCTB/DVRPA/OVRR/CBER/FDA February 27, 2007.

Prostate Cancer Screening Guidelines Across Canada Environmental Scan July 2015.

Vaccines and Related Biological Products Advisory Committee Meeting Hepatitis B Vaccine (Recombinant), Adjuvanted (HEPLISAV): Review of Immunogenicity.

Long-Term Tolerability of Ticagrelor for Secondary Prevention: Insights from PEGASUS-TIMI 54 Trial Marc P. Bonaca, MD, MPH on behalf of the PEGASUS-TIMI.

Text Message Reminders for Second Dose of Influenza Vaccine: A Randomized Controlled Trial Journal Club – October 28 th, 2015 Brian Skinner, PharmD PGY-1.

Position on HPV vaccinesAvailable from In July 2013, The Global Advisory Committee on Vaccine Safety (GACVS) of the WHO reconfirmed that there had been.

Cervical Cancer How We Can Prevent It Dr Quek Swee Chong Himalayan Women’s Health Project 30 August 2014.

Adolescent Vaccination: Taking It to the Schools Immunization Site Preferences Among Primarily Hispanic Middle School Parents Amy B. Middleman, MD, MSEd,

HVTN 702: A pivotal phase 2b/3 multi-site, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of ALVAC-HIV.

Date of download: 7/1/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Immunogenicity of 13-Valent Pneumococcal Conjugate.

Children’s Outcomes Research Program The Children’s Hospital Aurora, CO Children’s Outcomes Research Program The Children’s Hospital Aurora, CO Colorado.

QUALITY IMPROVEMENT FOR HPV VACCINATION

Final Learning Collaborative November/December 2016

Making Effective HPV Vaccine Recommendations

FNHSO Panorama Data Governance Forum

Principles of HPV vaccination Some derived from Phase III trials Some are based on clinical judgement / research HPV vaccines have no contraindications.

Human Papillomavirus Kenneth McCall, BSPharm, PharmD, BCGP

HPV Vaccines and Data Needed for Development of Recommendations in the United States Lauri E. Markowitz, MD Centers for Disease Control and Prevention.

Alcohol, Other Drugs, and Health: Current Evidence

Copyright © 2013 American Medical Association. All rights reserved.

HPV VACCINATION ——1st vaccine against cancer

ASSENT-3 PLUS 1,639 patients with STEMI Treatment Group A

HPV VACCINES Dr. Kirtan Krishna.

Nat. Rev. Clin. Oncol. doi: /nrclinonc

Short or long adjuvant treatment: can we use new trials to decide it?

World Health Organization

Women’s Health Care and Education Coalition

JAMA Pediatrics Journal Club Slides: Effect of Attendance of the Child in Childhood Obesity Treatment Boutelle KN, Rhee KE, Liang J, et al. Effect of attendance.

Influenza Experience: Highlights and Comments

Research Update: The HPV Vaccines

Approved Expansion of HPV Vaccination to Age 45: What Does It Mean?

Presentation transcript:

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

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

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

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?

Study Funded by: British Columbia Ministry of Health The Provincial Governments of Quebec and Nova Scotia

Control arms, Gardasil™ 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 Blinded outcome assessment 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 6

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 Take GMT of intervention group and compare to reference group (959 mMU/L divided by 575 mMU/L = 1.67 with a 95% CI of 1.46-1.91. Lower end of the 95% CI was greater than 0,5 (1.46) therefore the intervention arm is deemed to be non-inferior 7

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

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

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

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

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

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