著者

松岡 資 Osamu Matsuoka

出版者

創価大学通信教育部学会

雑誌

通信教育部論集 (ISSN:13442511)

巻号頁・発行日

no.19, pp.5-14, 2016-08-07

著者

Osamu Matsuoka Mugen Ujiie Hitoshi Kikuchi Sachiko Otake Danaya Chansinghakul Takahiro Inoue Kucku Varghese Nuchra Sirisuphmitr Tomoyuki Hashiguchi Betzana Zambrano Takahiro Nakama Carina Frago Emilia Jordanov Mandeep Singh Dhingra

出版者

National Institute of Infectious Diseases

雑誌

Japanese Journal of Infectious Diseases (ISSN:13446304)

巻号頁・発行日

pp.JJID.2022.272, (Released:2023-01-31)

参考文献数

33

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MenACYW-TT is a quadrivalent meningococcal tetanus toxoid-conjugate vaccine designed to prevent invasive meningococcal disease. The primary objective of this study was to demonstrate non-inferiority of the vaccine seroresponse to a single dose of MenACYW-TT compared to a licensed Meningococcal quadrivalent diphtheria-conjugate vaccine, MCV4-DT. This Phase III double-blind, multi-center study was conducted in meningococcal vaccine-naive participants aged 2-55 years in Japan (NCT04368429; JapicCTI-205288). Participants were randomized 1:1 to MenACYW-TT (n=180) or MCV4-DT (n=180). Functional antibodies against meningococcal serogroups A, C, W, and Y were measured using a serum bactericidal antibody assay with human complement (hSBA) at baseline (D0) and 30 days after vaccination (D30). Seroresponse was defined as post-vaccination titers ≥1:16 for participants with baseline titers <1:8; or ≥4-fold increase for participants with baseline titers ≥1:8. Safety data were collected for 30 days. Non-inferiority of the vaccine seroresponse vs MCV4-DT was demonstrated at D30 for each serogroup (A: 85.6% vs. 65.4%; C: 96.6% vs. 62.6%; W: 87.4% vs. 49.2%; Y: 97.7% vs. 63.5%, respectively). MenACYW-TT was well-tolerated, with no safety concerns identified. In conclusion, when administered as a single dose, MenACYW-TT was well tolerated with a non-inferior immune response compared to MCV4-DT, providing a potential alternative vaccine for this population.

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.