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Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries
- Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries
- Garland, 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.; Kang, J-H; Sakamoto, M.; Ryu, H-S; Bhatla, 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
- SCOPUS Author ID
- Issue Date
- Journal Title
- JOURNAL OF INFECTIOUS DISEASES
- JOURNAL OF INFECTIOUS DISEASES vol. 218, no. 1, pp. 95 - 108
- 9vHPV; Asia; cervical cancer; human papillomavirus; vaccine
- OXFORD UNIV PRESS INC
- SCIE; SCOPUS
- Document Type
- 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.
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