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

S M Garland, P Pitisuttithum, H Y S Ngan, C-H Cho, C-Y Lee, C-A Chen, Y C Yang, T-Y Chu, N-F Twu, R Samakoses, Y Takeuchi, T H Cheung, S C Kim, L-M Huang, B-G Kim, Y-T Kim, K-H Kim, Y-S Song, S Lalwani, J-H Kang, M Sakamoto, H-S Ryu, N Bhatla, H Yoshikawa, M C Ellison, S R Han, E Moeller, S Murata, M Ritter, M Sawata, C Shields, A Walia, G Perez, A Luxembourg, S M Garland, P Pitisuttithum, H Y S Ngan, C-H Cho, C-Y Lee, C-A Chen, Y C Yang, T-Y Chu, N-F Twu, R Samakoses, Y Takeuchi, T H Cheung, S C Kim, L-M Huang, B-G Kim, Y-T Kim, K-H Kim, Y-S Song, S Lalwani, J-H Kang, M Sakamoto, H-S Ryu, N Bhatla, H Yoshikawa, M C Ellison, S R Han, E Moeller, S Murata, M Ritter, M Sawata, C Shields, A Walia, G Perez, A Luxembourg

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.

Clinical trials registration: NCT00543543; NCT00943722.

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Source: PubMed

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