- 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.
- 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
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.