Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants from Asian Countries
Journal
Journal of Infectious Diseases
Journal Volume
218
Journal Issue
1
Pages
95-108
Date Issued
2018
Author(s)
Garland S.M.
Pitisuttithum P.
Ngan H.Y.S.
Cho C.-H.
Lee C.-Y.
Yang Y.C.
Chu T.-Y.
Twu N.-F.
Samakoses R.
Takeuchi Y.
Cheung T.H.
Kim S.C.
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.
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.
Publisher
Oxford University Press
Type
journal article