Overcoming barriers to HPV vaccination: non-inferiority of antibody response to human papillomavirus 16/18 vaccine in adolescents vaccinated with a two-dose vs. a three-dose schedule at 21 months

Vaccine
Eduardo Lazcano-PonceMauricio Hernández-Ávila

Abstract

For middle and low-income countries, the cost of HPV vaccines remains challenging. We conducted an open-label nonrandomized clinical trial evaluating immune response to the HPV-16/18 AS04-adjuvanted vaccine administered on a standard (months (M) 0-1-6) versus extended schedule (M 0-6-60) at 7, 21, 60, 72 and 120 months post-vaccination. Participants were females recruited in Morelos, Mexico: 474 girls aged 9-10 years and 500 women aged 18-24 years receiving a standard schedule, and 1026 girls aged 9-10 years receiving an extended schedule (currently the girls in the extended schedule had received only the first 2 doses). This report presents the interim analysis results for non-inferiority between the regimes conducted with the current available data at 21 months after the first dose, with serum antibodies assessed by ELISA. A pre-stated margin of non-inferiority was defined by post-vaccination geometric mean titer (GMT) ratio (upper 95% confidence interval [CI]≤2.0) between the standard and the two-dose schedule in girls at month 21. Immune response to the vaccine was strongest in adolescent girls and in the 3-dose group. Statistical non-inferiority of the two-dose versus three-dose groups was demonstrated. At 21 months, compa...Continue Reading

Associated Clinical Trials

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Citations

Dec 9, 2014·Expert Review of Vaccines·Didik SetiawanMaarten J Postma
Aug 22, 2015·Expert Review of Vaccines·Abbey B Berenson
Jul 9, 2014·Expert Review of Vaccines·Margaret A StanleyAnna R Giuliano
Jun 27, 2014·Expert Review of Vaccines·Annika M Hofstetter, Susan L Rosenthal
Dec 15, 2015·The Lancet Oncology·Rengaswamy SankaranarayananUNKNOWN Indian HPV Vaccine Study Group
Mar 5, 2016·Human Vaccines & Immunotherapeutics·Partha BasuRengaswamy Sankaranarayanan
Nov 22, 2015·Cancer Epidemiology·Patricia VillainRolando Herrero
Mar 11, 2015·Reviews in Medical Virology·Sara J McKeeGraham R Leggatt
Oct 5, 2015·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Rengaswamy Sankaranarayanan
Mar 18, 2015·Women's Health·Rengaswamy SankaranarayananNamory Keita
Jun 10, 2014·Journal of Paediatrics and Child Health·Julia M L Brotherton
May 7, 2015·The Lancet Oncology·Rolando HerreroLauri E Markowitz
Apr 23, 2016·Sexually Transmitted Diseases·Ana Katherine GonçalvesSteven S Witkin
May 14, 2016·Human Vaccines & Immunotherapeutics·Robine DonkenHester E de Melker
Oct 25, 2016·Vaccine·Benjamin D GrantRebecca Richards-Kortum
Dec 10, 2016·The Indian Journal of Medical Research·Rengaswamy SankaranarayananPartha Basu
Jan 18, 2018·Annals of Medicine·Eduardo de GomensoroT Mark Doherty
Jan 31, 2019·Salud pública de México·Margaret Stanley
Jan 31, 2019·Salud pública de México·Claudia RoblesMaribel Almonte
Dec 19, 2019·Expert Review of Vaccines·Margaret Stanley
May 10, 2018·The Cochrane Database of Systematic Reviews·Marc ArbynPierre Pl Martin-Hirsch
Jan 23, 2020·International Journal of Environmental Research and Public Health·Matthew AsareElectra D Paskett
Nov 3, 2017·Journal of Global Oncology·Silvina ArrossiSilvia de Sanjosé
Dec 10, 2014·Cancer Prevention Research·Joshua W WangRichard B S Roden

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