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

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.