Journal article
Evaluation of Type Replacement Following HPV16/18 Vaccination: Pooled Analysis of Two Randomized Trials
JE Tota, F Struyf, M Merikukka, P Gonzalez, AR Kreimer, D Bi, X Castellsagué, NS De Carvalho, SM Garland, DM Harper, N Karkada, K Peters, WAJ Pope, C Porras, W Quint, AC Rodriguez, M Schiffman, J Schussler, S Rachel Skinner, JC Teixeira Show all
Journal of the National Cancer Institute | OXFORD UNIV PRESS INC | Published : 2017
DOI: 10.1093/jnci/djw300
Abstract
Background: Current HPV vaccines do not protect against all oncogenic HPV types. Following vaccination, type replacement may occur, especially if different HPV types competitively interact during natural infection. Because of their common route of transmission, it is difficult to assess type interactions in observational studies. Our aim was to evaluate type replacement in the setting of HPV vaccine randomized controlled trials (RCTs). Methods: Data were pooled from the Costa Rica Vaccine Trial (CVT; NCT00128661) and PATRICIA trial (NCT001226810) - two large-scale, double-blind RCTs of the HPV-16/18 AS04-adjuvanted vaccine - to compare cumulative incidence of nonprotected HPV infections acro..
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Awarded by National Cancer Institute
Funding Acknowledgements
The Costa Rica HPV Vaccine Trial is a long-standing collaboration between investigators in Costa Rica and the National Cancer Institute (NCI). The trial is sponsored and funded by the NCI (contract N01-CP-11005), with funding support from the National Institutes of Health Office of Research on Women's Health. GlaxoSmithKline Biologicals SA provided vaccine and support for aspects of the trial associated with regulatory submission needs of the company under a Clinical Trials Agreement (FDA BB-IND 7920) during the four-year, randomized blinded phase of our study. John T. Schiller and Douglas R. Lowy report that they are named inventors on US Government-owned HPV vaccine patents that are licensed to GlaxoSmithKline and Merck and for which the National Cancer Institute receives licensing fees. They are entitled to limited royalties as specified by federal law. The PATRICIA trial was funded by GlaxoSmithKline Biologicals SA.