Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adults

• Main Authors: Hoan Jong Lee, Moon-Hyun Chung, Woo Joo Kim, Young Jin Hong, Kyong Min Choi, Jina Lee, Chi Eun Oh, Jo Anne Welsch, Kyung-Hyo Kim, Ki Bae Hong, Alemnew F. Dagnew, Hans Bock, Peter M. Dull, Tatjana Odrljin
• Format: Article
• Language: English
• Published: Elsevier 2014-11-01
• Series: International Journal of Infectious Diseases
• Subjects: Neisseria meningitidis; Conjugate vaccines; Quadrivalent meningococcal vaccine; Korea
• Online Access: http://www.sciencedirect.com/science/article/pii/S1201971214015689

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.