Hoan Jong Lee1, Moon-Hyun Chung2, Woo Joo Kim3, Young Jin Hong2, Kyong Min Choi4, Jina Lee5, Chi Eun Oh6, Jo Anne Welsch7, Kyung-Hyo Kim8, Ki Bae Hong9, Alemnew F Dagnew7, Hans Bock7, Peter M Dull7, Tatjana Odrljin7. 1. Seoul National University Children's Hospital, 101 Daehak-ro, Jongno-gu, Seoul 110-769, Korea; Seoul National University College of Medicine, Seoul, Korea. Electronic address: hoanlee@snu.ac.kr. 2. Inha University Hospital, Incheon, Korea. 3. Korea University Guro Hospital, Seoul, Korea. 4. Myongji Hospital, Kwandong University College of Medicine, Koyang, Korea. 5. Seoul National University Bundang Hospital, Seongnam, Korea. 6. Kosin University College of Medicine, Busan, Korea. 7. Novartis Vaccines and Diagnostics, Cambridge, Massachusetts, USA. 8. Ewha Womans University School of Medicine, Seoul, Korea. 9. Seoul National University Children's Hospital, 101 Daehak-ro, Jongno-gu, Seoul 110-769, Korea.
Abstract
OBJECTIVES: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. METHODS:Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. RESULTS:Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N=297) or a saline placebo (N=153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. CONCLUSIONS: Findings of this first study of a quadrivalent meningococcal polysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination.
RCT Entities:
OBJECTIVES: This phase III placebo-controlled study evaluated the immunogenicity and safety of MenACWY-CRM vaccination in healthy Korean adolescents and adults. METHODS: Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination against all four meningococcal serogroups. The IgG concentration specific for serogroup W capsular polysaccharide was measured in a subset of subjects in a post-hoc analysis. Adverse reactions were monitored throughout the study. RESULTS: Four hundred and fifty subjects were randomized 2:1 to receive MenACWY-CRM (N=297) or a saline placebo (N=153). MenACWY-CRM induced a good immune response against all four serogroups, with seroprotection rates (hSBA titers ≥8) of 79%, 99%, 98%, and 94% for serogroups A, C, W, and Y, respectively. Seroresponse rates were high for serogroups A, C, and Y, i.e. 76%, 86%, and 69%, respectively; the rate for serogroup W was 28%. MenACWY-CRM vaccine induced serum bactericidal antibodies against all four serogroups in a majority of subjects regardless of their baseline hSBA titers. MenACWY-CRM was generally well tolerated with most reactions being transient and mild to moderate in severity. CONCLUSIONS: Findings of this first study of a quadrivalent meningococcalpolysaccharide conjugate vaccine in Korean adults and adolescents demonstrated that a single dose of MenACWY-CRM was well tolerated and immunogenic, as indicated by the percentages of subjects with hSBA titers ≥8 (79%, 99%, 98%, and 94% of subjects) and geometric mean titers (48, 231, 147, and 107) against serogroups A, C, W, and Y, respectively, at 1 month post-vaccination.
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