著者

Osamu Matsuoka Daisuke Tsuzuki Katsuhisa Suzuki Tomoyuki Tanaka Yoshiharu Takagi Philipp Oster

出版者

National Institute of Infectious Diseases, Japanese Journal of Infectious Diseases Editorial Committee

雑誌

Japanese Journal of Infectious Diseases (ISSN:13446304)

巻号頁・発行日

pp.JJID.2020.411, (Released:2020-10-30)

参考文献数

17

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The quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Men-ACWY-D) is licensed in Japan since 2014. An earlier registration study demonstrated the immunogenicity of one dose in Japanese adults. Immunogenicity against serogroup C was lowest. Determination of the potential to increase the serogroup C response with a second dose was of interest. This study (NCT02591290) evaluated the safety and immunogenicity of two doses administered eight weeks apart to 60 healthy Japanese adults aged 20–55 years. Blood samples were collected 28–35 days after each vaccination. Immunogenicity endpoints included seroprotection and seroconversion rates. Safety assessments included systemic adverse events (AEs), non-serious AEs, and serious AEs. Fifty-eight (96.7%) participants completed the study. Seroprotection rates for serogroups A, C, W, and Y before vaccination were 76.8%, 26.8%, 26.8%, and 50.0%, increasing to 100%, 83.9%, 91.1%, and 96.4% and 100%, 92.9%, 94.6%, and 94.6%, respectively, after two doses. Seroconversion rates for the four serogroups were 100%, 93.8%, 97.1%, and 94.1% after the first dose and 100%, 96.9%, 100%, and 100% after the second. Increases between doses were insignificant. There were no safety concerns. The two-dose series is well tolerated but clinical benefit of a second dose within 8 weeks seemed to be low.

著者

Shinji Fukushima Hitoshi Kikuchi Mitsunobu Miyazu Atsuo Hamada Kazunobu Ouchi Hiroki Takagi Hanako Mihara Toru Sasaki Hayato Oka Valerie Bosch-Castells Philipp Oster

出版者

National Institute of Infectious Diseases, Japanese Journal of Infectious Diseases Editorial Committee

雑誌

Japanese Journal of Infectious Diseases (ISSN:13446304)

巻号頁・発行日

pp.JJID.2017.277, (Released:2018-06-29)

参考文献数

31

被引用文献数

6

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Meningococcal disease can cause significant disability and mortality. The quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Men-ACWY-D) protects against invasive meningococcal disease caused by serogroups A, C, W, and Y. This phase III, open-label, single-arm, multicenter study evaluated the safety and immunogenicity of a single vaccine dose in healthy Japanese adults. The study enrolled 200 participants 2-55 years of age. Immunogenicity was assessed by quantifying seroprotection rates (the proportion of participants with antibody titers ≥1:128 against capsular polysaccharide from all 4 serogroups, measured 28 days after vaccination). Safety endpoints included occurrence, nature, time to onset, duration, intensity, relationship to vaccination, and outcome of solicited and unsolicited adverse events (AEs) and serious AEs (SAEs). Participants included 194 adults, 2 adolescents, and 4 children. Among adults, seroprotection rates for serogroups A, C, W, and Y were 91.2%, 80.2%, 89.1%, and 93.8%, respectively. Seroconversion rates (proportion of participants with pre-vaccination titers of <1:4 and a ≥4-fold rise from baseline) were 87.3%, 83.0%, 94.4%, and 96.4%, respectively. No immediate AEs or reactions, SAEs, or deaths were reported in any age group. Men-ACWY-D is well tolerated and immunogenic, eliciting antibodies against capsular polysaccharides from all 4 serogroups in Japanese adults.