Japanese Journal of Infectious Diseases
Online ISSN : 1884-2836
Print ISSN : 1344-6304
ISSN-L : 1344-6304
Safety and Immunogenicity of the Quadrivalent HPV Vaccine in Japanese Boys: a Phase 3, Open-Label Study
Shinya MurataYuzuru TakeuchiKou YamanakaJun HayakawaMasashige YoshidaRuriko YokokawaAkira WakanaMiyuki SawataYoshiyuki Tanaka
キーワード: boys, HPV, immunogenicity, Japan, vaccine
ジャーナル フリー 早期公開

論文ID: JJID.2018.448


Human papillomavirus (HPV)-associated disease is common among men with HPV infection. A quadrivalent HPV (qHPV) vaccine has demonstrated 85.9% efficacy against HPV6/11/16/18-related persistent (≥6 month) infection in a study of Japanese men aged 16–26 yr. Here, we report results of an open-label study of the immunogenicity and tolerability of the qHPV vaccine (NCT02576054), conducted to bridge findings in Japanese men to Japanese boys aged 9–15 yr. A total of 100 boys completed a three-vaccination regimen (Day 1, Months 2, and 6), and 99 boys were included in the primary analysis population. The rate of seroconversion at 1 month after vaccine Dose 3 (Month 7) was high for each vaccine HPV type (anti-HPV6/11/16/18 seroconversion rates [95% CI]: 94.9% [85.5%, 98.3%], 99.0% [94.4%, 100.0%], 99.0% [94.5%, 100.0%], and 99.0% [94.4%, 100.0%], respectively) and anti-HPV6/11/16/18 geometric mean titers were 482.9 mMU/mL, 1052.8 mMU/mL, 3878.3 mMU/mL, and 1114.5 mMU/mL, respectively. Immune responses to qHPV vaccine were non-inferior among Japanese boys included in the current study compared with young Japanese men in a separate study. Injection-site reactions were the most common adverse events, and administration of the vaccine was well tolerated in Japanese boys.

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