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

被引：21

作者：

Struyf, Frank ^{[1
]}

Colau, Brigitte ^{[1
]}

Wheeler, Cosette M. ^{[2
,3
]}

Naud, Paulo ^{[4
]}

Garland, Suzanne ^{[5
,6
,7
]}

Quint, Wim ^{[8
]}

Chow, Song-Nan ^{[9
]}

Salmeron, Jorge ^{[10
]}

Lehtinen, Matti ^{[11
]}

Del Rosario-Raymundo, M. Rowena ^{[12
]}

Paavonen, Jorma ^{[13
]}

Teixeira, Julio C. ^{[14
]}

Julieta Germar, Maria ^{[15
]}

Peters, Klaus

Skinner, S. Rachel ^{[16
,17
]}

Limson, Genara ^{[18
]}

Castellsague, Xavier ^{[19
]}

Poppe, Willy A. J. ^{[20
]}

Ramjattan, Brian ^{[21
]}

Klein, Terry D. ^{[22
]}

Schwarz, Tino F. ^{[23
,24
]}

Chatterjee, Archana ^{[25
,26
]}

Tjalma, Wiebren A. A. ^{[27
]}

Diaz-Mitoma, Francisco ^{[28
]}

Lewis, David J. M. ^{[29
]}

Harper, Diane M. ^{[30
]}

Molijn, Anco ^{[8
]}

van Doorn, Leen-Jan ^{[8
]}

David, Marie-Pierre ^{[1
]}

Dubin, Gary ^{[31
]}

机构：

[1] GlaxoSmithKline Vaccines, Rixensart, Belgium

[2] Univ New Mexico, Hlth Sci Ctr, Dept Pathol, Albuquerque, NM 87131 USA

[3] Univ New Mexico, Hlth Sci Ctr, Dept Obstet & Gynecol, Albuquerque, NM 87131 USA

[4] Univ Fed Rio Grande do Sul, Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil

[5] Royal Womens Hosp, Dept Microbiol & Infect Dis, Melbourne, Vic, Australia

[6] Royal Childrens Hosp, Murdoch Childrens Res Inst, Melbourne, Vic, Australia

[7] Univ Melbourne, Dept Obstet & Gynaecol, Melbourne, Vic, Australia

[8] DDL Diagnost Lab, Rijswijk, Netherlands

[9] Natl Taiwan Univ, Coll Med & Hosp, Dept Obstet & Gynecol, Taipei 10764, Taiwan

[10] Inst Mexicano Seguro Social, Unidad Invest Epidemiol & Serv Salud, Cuernavaca, Morelos, Mexico

[11] Univ Tampere, Sch Publ Hlth, FIN-33101 Tampere, Finland

[12] San Pablo Coll Med Ctr, Dept Obstet & Gynecol, San Pablo City, Laguna, Philippines

[13] Univ Helsinki, Dept Obstet & Gynecol, Helsinki, Finland

[14] Univ Estadual Campinas, UNICAMP, Dept Tocoginecol, Campinas, SP, Brazil

[15] Univ Philippines, Coll Med, Philippine Gen Hosp, Manila, Philippines

[16] Telethon Inst Child Hlth Res, Vaccine Trials Grp, Sydney, NSW, Australia

[17] Univ Sydney, Childrens Hosp Westmead, Discipline Paediat & Child Hlth, Sydney, NSW 2006, Australia

[18] Univ Philippines, Coll Med, Philippine Gen Hosp, Makati Med Ctr, Makati, Philippines

[19] CIBER ESP, IDIBELL, Inst Catala Oncol, Lhospitalet De Llobregat, Catalonia, Spain

[20] Univ Hosp KU Leuven Gasthuisberg, Dept Gynaecol, Leuven, Belgium

[21] First Line Med Serv Ltd, St John, NF, Canada

[22] Heartland Res Associates LLC, Wichita, KS USA

[23] Univ Wurzburg, Acad Teaching Hosp, Stiftung Juliusspital, Cent Lab, D-97070 Wurzburg, Germany

[24] Univ Wurzburg, Acad Teaching Hosp, Stiftung Juliusspital, Vaccinat Ctr, D-97070 Wurzburg, Germany

[25] Univ S Dakota, Sanford Sch Med, Dept Pediat, Vermillion, SD 57069 USA

[26] Sanford Childrens Specialty Clin, Sioux Falls, SD USA

[27] Univ Antwerp, Univ Antwerp Hosp, Dept Obstet & Gynecol, Multidisciplinary Breast Clin,Gynecol Oncol Unit, B-2020 Antwerp, Belgium

[28] Adv Med Res Inst Canada, Subdury, ON, Canada

[29] Univ Surrey, Clin Res Ctr, Surrey, England

[30] Geisel Sch Med Dartmouth, Hanover, NH USA

[31] GlaxoSmithKline Vaccines, King Of Prussia, PA USA

来源：

CLINICAL AND VACCINE IMMUNOLOGY | 2015年 / 22卷 / 02期

关键词：

CERVICAL INTRAEPITHELIAL NEOPLASIA; OF-STUDY ANALYSIS; PARTICLE VACCINE; BROAD-SPECTRUM; DOUBLE-BLIND; SUSTAINED EFFICACY; YOUNG-WOMEN; CANCER; PREVENTION;

D O I：

10.1128/CVI.00457-14

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 (LiPA(25)) 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/LiPA(25) 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.

引用

页码：235 / 244

页数：10

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