Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries

被引：46

作者：

Garland, S. M. ^{[1
,2
]}

Pitisuttithum, P. ^{[3
]}

Ngan, H. Y. S. ^{[4
]}

Cho, C-H ^{[5
]}

Lee, C-Y ^{[6
]}

Chen, C-A ^{[7
]}

Yang, Y. C. ^{[8
]}

Chu, T-Y ^{[9
]}

Twu, N-F ^{[10
]}

Samakoses, R. ^{[11
]}

Takeuchi, Y. ^{[12
]}

Cheung, T. H. ^{[13
]}

Kim, S. C. ^{[14
]}

Huang, L-M ^{[15
]}

Kim, B-G ^{[16
]}

Kim, Y-T ^{[17
]}

Kim, K-H ^{[18
,19
]}

Song, Y-S ^{[20
]}

Lalwani, S. ^{[21
]}

Kang, J-H ^{[22
]}

Sakamoto, M. ^{[23
,24
]}

Ryu, H-S ^{[25
]}

Bhatla, N. ^{[26
]}

Yoshikawa, H. ^{[27
]}

Ellison, M. C. ^{[28
]}

Han, S. R. ^{[29
]}

Moeller, E. ^{[28
]}

Murata, S. ^{[29
]}

Ritter, M. ^{[28
]}

Sawata, M. ^{[29
]}

Shields, C. ^{[28
]}

Walia, A. ^{[28
]}

Perez, G. ^{[28
]}

Luxembourg, A. ^{[28
]}

机构：

[1] Univ Melbourne, Royal Childrens Hosp, Murdoch Childrens Res Inst,Dept Infect Dis & Micr, Royal Womens Hosp,Western Pacific Reg HPV Labnet, Parkville, Vic, Australia

[2] Univ Melbourne, Dept Obstet & Gynaecol, Parkville, Vic, Australia

[3] Mahidol Univ, Vaccine Trial Ctr, Salaya, Nakhon Pathom, Thailand

[4] Univ Hong Kong, Dept Obstet & Gynaecol, Hong Kong, Hong Kong, Peoples R China

[5] Keimyung Univ, Sch Med, Dept Obstet & Gynecol, Daegu, South Korea

[6] Chang Gung Mem Hosp, Chiayi Branch, Dept Gynecol, Taipei, Taiwan

[7] Natl Taiwan Univ Hosp, Dept Obstet & Gynecol, Taipei, Taiwan

[8] MacKay Mem Hosp, Taipei, Taiwan

[9] Tzu Chi Med Ctr, Hualien, Taiwan

[10] Taipei Vet Gen Hosp, Dept Obstet & Gynecol, Taipei, Taiwan

[11] Phramongkutklao Hosp, Dept Pediat, Bangkok, Thailand

[12] Fukui Gen Hosp, Fukui, Japan

[13] Chinese Univ Hong Kong, Dept Obstet & Gynaecol, Hong Kong, Hong Kong, Peoples R China

[14] Ewha Womans Univ, Sch Med, Mokdong Hosp, Div Gynecol Oncol, Seoul, South Korea

[15] Natl Taiwan Univ Hosp, Dept Pediat, Taipei, Taiwan

[16] Sungkyunkwan Univ, Dept Obstet & Gynecol, Samsung Med Ctr, Sch Med, Seoul, South Korea

[17] Univ Ulsan, Coll Med, Dept Obstet & Gynecol, Asian Med Ctr, Ulsan, South Korea

[18] Ewha Womans Univ, Coll Med, Dept Pediat, Seoul, South Korea

[19] Ewha Womans Univ, Coll Med, Ctr Vaccine Evaluat & Study, Seoul, South Korea

[20] Seoul Natl Univ, Coll Med, Obstet & Gynecol, Seoul, South Korea

[21] Bharati Vidyapeeth Deemed Univ Med Coll & Hosp, Pune, Maharashtra, India

[22] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Dept Pediat, Seoul, South Korea

[23] Jikei Univ, Sasaki Fdn Kyoundo Hosp, Dept Gynaecol, Tokyo, Japan

[24] Jikei Univ, Sch Med, Dept Obstet & Gynaecol, Tokyo, Japan

[25] Ajou Univ, Sch Med, Dept Obstet & Gynecol, Suwon, South Korea

[26] All India Inst Med Sci, Dept Obstet & Gynaecol, New Delhi, India

[27] Ibaraki Cent Hosp, Kasama, Ibaraki, Japan

[28] Merck & Co Inc, Kenilworth, NJ USA

[29] MSD KK, Tokyo, Japan

来源：

JOURNAL OF INFECTIOUS DISEASES | 2018年 / 218卷 / 01期

关键词：

9vHPV; Asia; cervical cancer; human papillomavirus; vaccine; HPV VACCINE; COST-EFFECTIVENESS; PHASE-III; GENOTYPE ATTRIBUTION; PARTICLE VACCINE; CLINICAL-TRIALS; CERVICAL-CANCER; IMPACT; QUADRIVALENT; METAANALYSIS;

D O I：

10.1093/infdis/jiy133

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background. A 9-valent human papillomavirus-6/11/16/18/31/33/45/52/58 (9vHPV) vaccine extends coverage to 5 next most common oncogenic types (31/33/45/52/58) in cervical cancer versus quadrivalent HPV (qHPV) vaccine. We describe efficacy, immunogenicity, and safety in Asian participants (India, Hong Kong, South Korea, Japan, Taiwan, and Thailand) from 2 international studies: a randomized, double-blinded, qHPV vaccine-controlled efficacy study (young women aged 16-26 years; NCT00543543; Study 001); and an immunogenicity study (girls and boys aged 9-15 years; NCT00943722; Study 002). Methods. Participants (N = 2519) were vaccinated at day 1 and months 2 and 6. Gynecological samples (Study 001 only) and serum were collected for HPV DNA and antibody assessments, respectively. Injection-site and systemic adverse events (AEs) were monitored. Data were analyzed by country and vaccination group. Results. 9vHPV vaccine prevented HPV-31/33/45/52/58-related persistent infection with 90.4%-100% efficacy across included countries. At month 7, >= 97.9% of participants seroconverted for each HPV type. Injection-site AEs occurred in 77.7%-83.1% and 81.9%-87.5% of qHPV and 9vHPV vaccine recipients in Study 001, respectively, and 62.4%-85.7% of girls/boys in Study 002; most were mild to moderate. Conclusions. The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Asian participants. Data support 9vHPV vaccination programs in Asia.

引用

页码：95 / 108

页数：14

共 48 条

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