Efficacy of Human Papillomavirus 16 and 18 (HPV-16/18) AS04-Adjuvanted Vaccine against Cervical Infection and Precancer in Young Women: Final Event-Driven Analysis of the Randomized, Double-Blind PATRICIA Trial

被引：80

作者：

Apter, Dan ^{[1
]}

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

Paavonen, Jorma ^{[4
]}

Castellsague, Xavier ^{[5
]}

Garland, Suzanne M. ^{[6
,7
]}

Skinner, S. Rachel ^{[8
,9
]}

Naud, Paulo ^{[10
]}

Salmeron, Jorge ^{[11
,12
]}

Chow, Song-Nan ^{[13
]}

Kitchener, Henry C. ^{[14
]}

Teixeira, Julio C. ^{[15
]}

Jaisamram, Unnop ^{[16
]}

Limson, Genara ^{[17
]}

Szarewski, Anne ^{[18
]}

Romanowski, Barbara ^{[19
]}

Aoki, Fred Y. ^{[20
]}

Schwarz, Tino F. ^{[21
,22
]}

Poppe, Willy A. J. ^{[23
]}

Xavier Bosch, F. ^{[24
]}

Mindel, Adrian ^{[25
]}

De Sutter, Philippe

Hardt, Karin ^{[26
,27
]}

Zahaf, Toufik ^{[26
,27
]}

Descamps, Dominique ^{[26
,27
]}

Struyf, Frank ^{[26
,27
]}

Lehtinen, Matti ^{[28
]}

Dubin, Gary ^{[29
]}

机构：

[1] Sexual Hlth Clin, Family Federat Finland, Helsinki, Finland

[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 Helsinki, Dept Obstet & Ginecol, Helsinki, Finland

[5] Hosp Llobregat, Biomed Res Ctr Network Epidemiol & Publ Hlth CIBE, DIBELL, ICO,Canc Epidemiol Res Program, Catalonia, Spain

[6] Univ Melbourne, Royal Womens Hosp, Murdoch Childrens Res Inst, Microbiol & Infect Dis Dept, Melbourne, Vic, Australia

[7] Univ Melbourne, Murdoch Childrens Res Inst, Dept Obstet & Gynaecol, Melbourne, Vic, Australia

[8] Telethon Inst Child Hlth Res, Vaccine Trials Grp, Perth, WA, Australia

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

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

[11] Inst Mexicano Seguro Social, Unidad Invest Epidemiol, Cuernavaca, Morelos, Mexico

[12] Inst Mexicano Seguro Social, Serv Salud, Cuernavaca, Morelos, Mexico

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

[14] St Marys Hosp, Cent Manchester Univ Hosp NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, Manchester M13 0JH, Lancs, England

[15] Univ Estadual Campinas, Campinas, SP, Brazil

[16] Chulalongkorn Univ, Fac Med, Dept Obstet & Gynaecol, Bangkok 10330, Thailand

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

[18] Queen Mary Univ London, Ctr Canc Prevent, Wolfson Inst Prevent Med, London, England

[19] Univ Alberta, Edmonton, AB, Canada

[20] Univ Manitoba, Winnipeg, MB, Canada

[21] Univ Wurzburg, Acad Teaching Hosp, Stiftung Juliusspital, Cent Lab, Wurzburg, Germany

[22] Univ Wurzburg, Acad Teaching Hosp, Stiftung Juliusspital, Vaccinat Ctr, Wurzburg, Germany

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

[24] Network Cooperat Canc Res RTICC, Inst Catala Oncol, IDIBELL, Canc Epidemiol Res Program, Catalonia, Spain

[25] Ctr AIDS Programme Res Soth Africa, Durban, South Africa

[26] Vrije Univ Brussel, Univ Ziekenhuis Brussel, Afdelingshoofd Gynaecol Oncol, Brussels, Belgium

[27] GSK Vaccines, Wavre, Belgium

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

[29] GSK Vaccines, King Of Prussia, PA USA

来源：

CLINICAL AND VACCINE IMMUNOLOGY | 2015年 / 22卷 / 04期

关键词：

OF-STUDY ANALYSIS; PARTICLE VACCINE; HPV-VACCINATION; FOLLOW-UP; TYPE-16; CANCER; PREVALENCE; SAFETY; IMMUNIZATION; PREVENTION;

D O I：

10.1128/CVI.00591-14

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

We report final event-driven analysis data on the immunogenicity and efficacy of the human papillomavirus 16 and 18 ((HPV16/18) AS04-adjuvanted vaccine in young women aged 15 to 25 years from the PApilloma TRIal against Cancer In young Adults (PATRICIA). The total vaccinated cohort (TVC) included all randomized participants who received at least one vaccine dose (vaccine, n = 9,319; control, n = 9,325) at months 0, 1, and/or 6. The TVC-naive (vaccine, n = 5,822; control, n = 5,819) had no evidence of high-risk HPV infection at baseline, approximating adolescent girls targeted by most HPV vaccination programs. Mean follow-up was approximately 39 months after the first vaccine dose in each cohort. At baseline, 26% of women in the TVC had evidence of past and/or current HPV-16/18 infection. HPV-16 and HPV-18 antibody titers postvaccination tended to be higher among 15- to 17-year-olds than among 18- to 25-year-olds. In the TVC, vaccine efficacy (VE) against cervical intraepithelial neoplasia grade 1 or greater (CIN1+), CIN2+, and CIN3+ associated with HPV-16/18 was 55.5% (96.1% confidence interval [CI], 43.2, 65.3), 52.8% (37.5, 64.7), and 33.6% (-1.1, 56.9). VE against CIN1+, CIN2+, and CIN3+ irrespective of HPV DNA was 21.7% (10.7, 31.4), 30.4% (16.4, 42.1), and 33.4% (9.1, 51.5) and was consistently significant only in 15- to 17-year-old women (27.4% [10.8, 40.9], 41.8% [22.3, 56.7], and 55.8% [19.2, 76.9]). In the TVC-naive, VE against CIN1+, CIN2+, and CIN3+ associated with HPV-16/ 18 was 96.5% (89.0, 99.4), 98.4% (90.4, 100), and 100% (64.7, 100), and irrespective of HPV DNA it was 50.1% (35.9, 61.4), 70.2% (54.7, 80.9), and 87.0% (54.9, 97.7). VE against 12-month persistent infection with HPV-16/18 was 89.9% (84.0, 94.0), and that against HPV-31/33/45/51 was 49.0% (34.7, 60.3). In conclusion, vaccinating adolescents before sexual debut has a substantial impact on the overall incidence of high-grade cervical abnormalities, and catch-up vaccination up to 18 years of age is most likely effective.

引用

页码：361 / 373

页数：13

共 50 条

[21] Efficacy of AS04-Adjuvanted Vaccine Against Human Papillomavirus (HPV) Types 16 and 18 in Clearing Incident HPV Infections: Pooled Analysis of Data From the Costa Rica Vaccine Trial and the PATRICIA Study
Tota, Joseph E.
Struyf, Frank
Hildesheim, Allan
Gonzalez, Paula
Ryser, Martin
Herrero, Rolando
Schussler, John
Karkada, Naveen
Rodriguez, Ana Cecilia
Folschweiller, Nicolas
Porras, Carolina
Schiffman, Mark
Schiller, John T.
Quint, Wim
Kreimer, Aimee R.
Lehtinen, Matti
Wheeler, Cosette M.
Sampson, Joshua N.
JOURNAL OF INFECTIOUS DISEASES, 2021, 223 (09) : 1576 - 1581
[22] Persistence of immune response to HPV-16/18 AS04-adjuvanted cervical cancer vaccine in women aged 15-55 years
Schwarz, Tino F.
Spaczynski, Marek
Schneider, Achim
Wysocki, Jacek
Galaj, Andrzej
Schulze, Karin
Poncelet, Sylviane
Catteau, Gregory
Thomas, Florence
Descamps, Dominique
HUMAN VACCINES, 2011, 7 (09): : 958 - 965
[23] Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in HIV-positive women in South Africa: A partially-blind randomised placebo-controlled study
Denny, Lynette
Hendricks, Bronwyn
Gordon, Chivaugn
Thomas, Florence
Hezareh, Marjan
Dobbelaere, Kurt
Durand, Christelle
Herve, Caroline
Descamps, Dominique
VACCINE, 2013, 31 (48) : 5745 - 5753
[24] Randomized Trial: Immunogenicity and Safety of Coadministered Human Papillomavirus-16/18 AS04-Adjuvanted Vaccine and Combined Hepatitis A and B Vaccine in Girls
Pedersen, Court
Breindahl, Morten
Aggarwal, Naresh
Berglund, Johan
Oroszlan, Gyoergy
Silfverdal, Sven Arne
Szuts, Peter
O'Mahony, Michael
David, Marie-Pierre
Dobbelaere, Kurt
Dubin, Gary
Descamps, Dominique
JOURNAL OF ADOLESCENT HEALTH, 2012, 50 (01) : 38 - 46
[25] Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials
Kreimer, Aimee R.
Struyf, Frank
Del Rosario-Raymundo, Mora Rowena
Hildeshim, Allan
Skinner, S. Rachel
Wacholder, Sholom
Garland, Suzanne M.
Herrero, Rolando
David, Marfe-Pierre
Mfeeler, Cosette M.
LANCET ONCOLOGY, 2015, 16 (07) : 775 - 786
[26] Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Indian women
Bhatla, Neerja
Suri, Vanita
Basu, Partha
Shastri, Surendra
Datta, Sanjoy K.
Bi, Dan
Descamps, Dominique J.
Bock, Hans L.
JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH, 2010, 36 (01) : 123 - 132
[27] Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention A pooled analysis of 11 clinical trials
Descamps, Dominique
Hardt, Karin
Spiessens, Bart
Izurieta, Patricia
Verstraeten, Thomas
Breuer, Thomas
Dubin, Gary
HUMAN VACCINES, 2009, 5 (05): : 332 - 340
[28] Long-term persistence of systemic and mucosal immune response to HPV-16/18 AS04-adjuvanted vaccine in preteen/adolescent girls and young women
Petaja, Tiina
Pedersen, Court
Poder, Airi
Strauss, Gitte
Catteau, Gregory
Thomas, Florence
Lehtinen, Matti
Descamps, Dominique
INTERNATIONAL JOURNAL OF CANCER, 2011, 129 (09) : 2147 - 2157
[29] Effectiveness of the AS04-adjuvanted HPV-16/18 vaccine in reducing oropharyngeal HPV infections in young females-Results from a community-randomized trial
Lehtinen, Matti
Apter, Dan
Eriksson, Tiina
Harjula, Katja
Hokkanen, Mari
Lehtinen, Tuomas
Natunen, Kari
Damaso, Silvia
Soila, Maaria
Bi, Dan
Struyf, Frank
INTERNATIONAL JOURNAL OF CANCER, 2020, 147 (01) : 170 - 174
[30] Efficacy of a bivalent HPV 16/18 vaccine against anal HPV 16/18 infection among young women: a nested analysis within the Costa Rica Vaccine Trial
Kreimer, Aimee R.
Gonzalez, Paula
Katki, Hormuzd A.
Porras, Carolina
Schiffman, Mark
Cecilia Rodriguez, Ana
Solomon, Diane
Jimenez, Silvia
Schiller, John T.
Lowy, Douglas R.
van Doorn, Leen-Jan
Struijk, Linda
Quint, Wim
Chen, Sabrina
Wacholder, Sholom
Hildesheim, Allan
Herrero, Rolando
LANCET ONCOLOGY, 2011, 12 (09) : 862 - 870

← 1 2 3 4 5 →