Journal article
Post hoc analysis of the PATRICIA randomized trial of the efficacy of human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against incident and persistent infection with nonvaccine oncogenic HPV types using an alternative multiplex type-specific PCR assay for HPV DNA
F Struyf, B Colau, CM Wheeler, P Naud, S Garland, W Quint, SN Chow, J Salmerón, M Lehtinen, MR Del Rosario-Raymundo, J Paavonen, JC Teixeira, MJ Maria Julieta Germar, K Peters, R Skinner, G Limson, X Castellsagué, WAJ Poppe, B Ramjattan, TD Klein Show all
Clinical and Vaccine Immunology | Published : 2015
DOI: 10.1128/CVI.00457-14
Abstract
The efficacy of the human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against cervical infections with HPV in the Papilloma Trial against Cancer in Young Adults (PATRICIA) was evaluated using a combination of the broad-spectrum L1-based SPF10 PCR-DNA enzyme immunoassay (DEIA)/line probe assay (LiPA25) system with type-specific PCRs for HPV-16 and -18. Broad-spectrum PCR assays may underestimate the presence of HPV genotypes present at relatively low concentrations in multiple infections, due to competition between genotypes. Therefore, samples were retrospectively reanalyzed using a testing algorithm incorporating the SPF10 PCR-DEIA/LiPA25 plus a novel E6-based multiplex t..
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Funding Acknowledgements
This work was supported by GlaxoSmithKline Vaccines (registered as GlaxoSmithKline Biologicals SA). B.C., M.-P.D., G.D., and F.S. are employees of the GlaxoSmithKline group of companies (GSK). B.C., M.-P.D., G.D., and F.S. own stock options/restricted shares of GSK. G.D. and B.C. hold patents in the HPV and the herpes simplex virus vaccine fields. X.C., S.G., M.L., P.N., J.S., S.R.S., J.C.T., and C.M.W. declare that their institutions received grants to carry out HPV clinical studies from GSK, Sanofi Pasteur MSD, or Merck & Co. X.C. received personal fees from Sanofi Pasteur MSD. A.C. served on the Speakers Bureau and Advisory Boards for GSK and Merck and received honoraria and travel expenses for related meetings. S.G. received personal fees from GSK as a consultant for EXCEL and received consulting fees from Sanofi Pasteur and Merck. A.M. declares that his company received payments from GSK for HPV testing laboratory services and for consultancy work for GSK related to clinical and epidemiological studies. M.R.D.R.-R. declares that she received fees from GSK for her participation in the Speakers Bureau and for travel to an investigator's meeting. J.S. declares that he received grants from Qiagen. T.F.S. declares that he received personal fees from GSK. S.R.S. declares that she received support from GSK to attend a scientific congress to present the results of the study and received honoraria for attendance at global advisory boards and educational forums; her institution received a grant from CSL to conduct an investigator-driven research project. J.C.T. declares that he received personal fees from GSK for his participation in lectures, the Speakers Bureau, and Advisory Boards. W.A.A.T. declares that he received support for travel for the study and other purposes from GSK and Sanofi Pasteur. C.M.W. declares that she received support from Roche Molecular Systems for equipment and reagents for HPV genotyping studies. S.-N.C., F.D.M., M.J.G., D.M.H., T.D.K, D.J.M.L., G.L., J.P., K.P., W.A.J.P., W.Q., B.R., and L.-J.V.D. declare that they have no conflicts of interest.