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. KangM. 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

Research output: Contribution to journalArticlepeer-review

20 Scopus citations

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.

Original languageEnglish
Pages (from-to)95-108
Number of pages14
JournalJournal of Infectious Diseases
Volume218
Issue number1
DOIs
StatePublished - 5 Jun 2018

Keywords

  • 9vHPV
  • Asia
  • cervical cancer
  • human papillomavirus
  • vaccine

Fingerprint

Dive into the research topics of 'Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants from Asian Countries'. Together they form a unique fingerprint.

Cite this