Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries
Web of Science
AuthorGarland, SM; Pitisuttithum, P; Ngan, HYS; Cho, C-H; Lee, C-Y; Chen, C-A; Yang, YC; Chu, T-Y; Twu, N-F; Samakoses, R; ...
Source TitleJournal of Infectious Diseases
PublisherOXFORD UNIV PRESS INC
University of Melbourne Author/sWark, Suzanne
AffiliationObstetrics and Gynaecology
Document TypeJournal Article
CitationsGarland, S. M., Pitisuttithum, P., Ngan, H. Y. S., Cho, C. -H., Lee, C. -Y., Chen, C. -A., Yang, Y. C., Chu, T. -Y., Twu, N. -F., Samakoses, R., Takeuchi, Y., Cheung, T. H., Kim, S. C., Huang, L. -M., Kim, B. -G., Kim, Y. -T., Kim, K. -H., Song, Y. -S., Lalwani, S. ,... Luxembourg, A. (2018). Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries. JOURNAL OF INFECTIOUS DISEASES, 218 (1), pp.95-108. https://doi.org/10.1093/infdis/jiy133.
Access StatusOpen Access
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. Clinical Trials Registration: NCT00543543; NCT00943722.
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