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

Title
Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries
Authors
Garland, S. M.Pitisuttithum, P.Ngan, H. Y. S.Cho, C-HLee, C-YChen, C-AYang, Y. C.Chu, T-YTwu, N-FSamakoses, R.Takeuchi, Y.Cheung, T. H.Kim, S. C.Huang, L-MKim, B-GKim, Y-TKim, K-HSong, Y-SLalwani, S.Kang, J-HSakamoto, M.Ryu, H-SBhatla, N.Yoshikawa, H.Ellison, M. C.Han, S. R.Moeller, E.Murata, S.Ritter, M.Sawata, M.Shields, C.Walia, A.Perez, G.Luxembourg, A.
Ewha Authors
김경효
SCOPUS Author ID
김경효scopus
Issue Date
2018
Journal Title
JOURNAL OF INFECTIOUS DISEASES
ISSN
0022-1899JCR Link

1537-6613JCR Link
Citation
JOURNAL OF INFECTIOUS DISEASES vol. 218, no. 1, pp. 95 - 108
Keywords
9vHPVAsiacervical cancerhuman papillomavirusvaccine
Publisher
OXFORD UNIV PRESS INC
Indexed
SCI; SCIE; SCOPUS WOS scopus
Document Type
Article
Abstract
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.
DOI
10.1093/infdis/jiy133
Appears in Collections:
의과대학 > 의학과 > Journal papers
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