Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries
- 주제(키워드) 9vHPV , Asia , cervical cancer , human papillomavirus , vaccine
- 주제(기타) Immunology; Infectious Diseases; Microbiology
- 설명문(일반) [Garland, S. M.] Univ Melbourne, Royal Childrens Hosp, Murdoch Childrens Res Inst,Dept Infect Dis & Micr, Royal Womens Hosp,Western Pacific Reg HPV Labnet, Parkville, Vic, Australia; [Garland, S. M.] Univ Melbourne, Dept Obstet & Gynaecol, Parkville, Vic, Australia; [Pitisuttithum, P.] Mahidol Univ, Vaccine Trial Ctr, Salaya, Nakhon Pathom, Thailand; [Ngan, H. Y. S.] Univ Hong Kong, Dept Obstet & Gynaecol, Hong Kong, Hong Kong, Peoples R China; [Cho, C-H] Keimyung Univ, Sch Med, Dept Obstet & Gynecol, Daegu, South Korea; [Lee, C-Y] Chang Gung Mem Hosp, Chiayi Branch, Dept Gynecol, Taipei, Taiwan; [Chen, C-A] Natl Taiwan Univ Hosp, Dept Obstet & Gynecol, Taipei, Taiwan; [Yang, Y. C.] MacKay Mem Hosp, Taipei, Taiwan; [Chu, T-Y] Tzu Chi Med Ctr, Hualien, Taiwan; [Twu, N-F] Taipei Vet Gen Hosp, Dept Obstet & Gynecol, Taipei, Taiwan; [Samakoses, R.] Phramongkutklao Hosp, Dept Pediat, Bangkok, Thailand; [Takeuchi, Y.] Fukui Gen Hosp, Fukui, Japan; [Cheung, T. H.] Chinese Univ Hong Kong, Dept Obstet & Gynaecol, Hong Kong, Hong Kong, Peoples R China; [Kim, S. C.] Ewha Womans Univ, Sch Med, Mokdong Hosp, Div Gynecol Oncol, Seoul, South Korea; [Huang, L-M] Natl Taiwan Univ Hosp, Dept Pediat, Taipei, Taiwan; [Kim, B-G] Sungkyunkwan Univ, Dept Obstet & Gynecol, Samsung Med Ctr, Sch Med, Seoul, South Korea; [Kim, Y-T] Univ Ulsan, Coll Med, Dept Obstet & Gynecol, Asian Med Ctr, Ulsan, South Korea; [Kim, K-H] Ewha Womans Univ, Coll Med, Dept Pediat, Seoul, South Korea; [Kim, K-H] Ewha Womans Univ, Coll Med, Ctr Vaccine Evaluat & Study, Seoul, South Korea; [Song, Y-S] Seoul Natl Univ, Coll Med, Obstet & Gynecol, Seoul, South Korea; [Lalwani, S.] Bharati Vidyapeeth Deemed Univ Med Coll & Hosp, Pune, Maharashtra, India; [Kang, J-H] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Dept Pediat, Seoul, South Korea; [Sakamoto, M.] Jikei Univ, Sasaki Fdn Kyoundo Hosp, Dept Gynaecol, Tokyo, Japan; [Sakamoto, M.] Jikei Univ, Sch Med, Dept Obstet & Gynaecol, Tokyo, Japan; [Ryu, H-S] Ajou Univ, Sch Med, Dept Obstet & Gynecol, Suwon, South Korea; [Bhatla, N.] All India Inst Med Sci, Dept Obstet & Gynaecol, New Delhi, India; [Yoshikawa, H.] Ibaraki Cent Hosp, Kasama, Ibaraki, Japan; [Ellison, M. C.; Moeller, E.; Ritter, M.; Shields, C.; Walia, A.; Perez, G.; Luxembourg, A.] Merck & Co Inc, Kenilworth, NJ USA; [Han, S. R.; Murata, S.; Sawata, M.] MSD KK, Tokyo, Japan
- 등재 SCIE, SCOPUS
- 발행기관 OXFORD UNIV PRESS INC
- 발행년도 2018
- URI http://www.dcollection.net/handler/ewha/000000159760
- 본문언어 영어
- Published As http://dx.doi.org/10.1093/infdis/jiy133
초록/요약
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.
more