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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

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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

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Título 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
Autor Struyf, Frank
Colau, Brigitte
Wheeler, Cosette M.
Naud, Paulo Sergio Viero
Garland, Suzanne M.
Quint, Wim G. V.
Chow, Song-Nan
Salmerón, Jorge
Lehtinen, Matti
Del Rosario-Raymundo, Maria Rowena
Paavonen, Jorma
Teixeira, Júlio César
Germar, Maria Julieta V.
Peters, Klaus
Skinner, S. Rachel
Limson, Genara
Castellsague, Xavier
Poppe, Willy A. J.
Ramjattan, Brian
Klein, Terry D.
Schwarz, Tino F.
Chatterjee, Archana
Tjalma, Wiebren A. A.
Diaz-Mitoma, Francisco
Lewis, David J. M.
Harper, Diane M.
Molijn, Anco
Doorn, Leen-Jan van
David, Marie-Pierre
Dubin, Gary
HPV PATRICIA Study Group
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 type-specific PCR and reverse hybridization assay (MPTS12 RHA), which permits detection of a panel of nine oncogenic HPV genotypes (types 16, 18, 31, 33, 35, 45, 52, 58, and 59). For the vaccine against HPV types 16 and 18, there was no major impact on estimates of vaccine efficacy (VE) for incident or 6-month or 12-month persistent infections when the MPTS12 RHA was included in the testing algorithm versus estimates with the protocol-specified algorithm. However, the alternative testing algorithm showed greater sensitivity than the protocol-specified algorithm for detection of some nonvaccine oncogenic HPV types. More cases were gained in the control group than in the vaccine group, leading to higher point estimates of VE for 6-month and 12-month persistent infections for the nonvaccine oncogenic types included in the MPTS12 RHA assay (types 31, 33, 35, 45, 52, 58, and 59). This post hoc analysis indicates that the per-protocol testing algorithm used in PATRICIA underestimated the VE against some nonvaccine oncogenic HPV types and that the choice of the HPV DNA testing methodology is important for the evaluation of VE in clinical trials. (This study has been registered at ClinicalTrials.gov under registration no. NCT00122681.).
Contido em Clinical and vaccine immunology. Washington. Vol. 22, no. 2 (Feb. 2015), p. 235-244
Assunto Papillomavirus humano 16
Papillomavirus humano 18
Vacina
Origem Estrangeiro
Tipo Artigo de periódico
URI http://hdl.handle.net/10183/115358
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