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

Garland, SM | Pitisuttithum, P | Ngan, HYS | Cho, CH | Lee, CY | Chen, CA | Yang, YC | Chu, TY | Twu, NF | Samakoses, R | Takeuchi, Y | Cheung, TH | Kim, SC | Huang, LM | Kim, BG | Kim, YT | Kim, KH | Song, YS | Lalwani, S | Kang, JH | Sakamoto, M | Ryu, HS  | Bhatla, N | Yoshikawa, H | Ellison, MC | Han, SR | Moeller, E | Murata, S | Ritter, M | Sawata, M | Shields, C | Walia, A | Perez, G | Luxembourg, A
The Journal of infectious diseases, 218(1). : 95-108, 2018
Journal Title
The Journal of infectious diseases
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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Journal Papers > School of Medicine / Graduate School of Medicine > Obstetrics & Gynecology
Ajou Authors
유, 희석
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