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

• DOI: 10.1093/infdis/jiy133
• Publication Date: 2018-03-07T23:13:02Z
• Authors: 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
• Keywords: Adult; Male; Asia; Adolescent; Drug-Related Side Effects and Adverse Reactions; Papillomavirus Infections; 610; Genitalia, Female; Antibodies, Viral; 16. Peace & justice; 3. Good health; 618; Major Articles and Brief Reports; Young Adult; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Double-Blind Method; Humans; Female; Papillomavirus Vaccines; Child; Papillomaviridae

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 Asian participants (India, Hong Kong, South Korea, Japan, Taiwan, Thailand) from 2 international studies: a randomized, double-blinded, qHPV vaccine-controlled efficacy study (young women aged 16-26 years; NCT00543543; Study 001); an immunogenicity (girls boys 9-15 NCT00943722; 002).Participants (N = 2519) were vaccinated at day 1 months 6. Gynecological samples (Study 001 only) serum collected for DNA antibody assessments, respectively. Injection-site systemic adverse events (AEs) monitored. Data analyzed by country vaccination group.9vHPV prevented HPV-31/33/45/52/58-related persistent infection with 90.4%-100% across included countries. At month 7, ≥97.9% of seroconverted each type. AEs occurred 77.7%-83.1% 81.9%-87.5% 9vHPV recipients 001, respectively, 62.4%-85.7% girls/boys 002; mild moderate.The is efficacious, immunogenic, well tolerated participants. support programs Asia.NCT00543543; NCT00943722.