Safety and immunogenicity of an investigational quadrivalent meningococcal CRM197 conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America

Abstract

Background: This study compared the investigational quadrivalent meningococcal CRM 197 conjugate vaccine, MenACWY-CRM, with licensed quadrivalent polysaccharide (MPSV4) and conjugate (MenACWY-D) meningococcal vaccines. Methods: In this phase III multicenter study, 2505 adults (aged 19-55 years) were randomized to receive either MenACWY-CRM or MenACWY-D, and 326 adults (aged 56-65 years) were randomized to receive either MenACWY-CRM or MPSV4. Sera obtained pre-vaccination and at 1-month post-vaccination were tested for serogroup-specific serum bactericidal activity using human complement (hSBA) for immunogenicity non-inferiority and superiority analyses. Results: The vaccines in all groups were well tolerated. In the 19-55 years age group, post-vaccination geometric mean titers (GMTs) were consistently higher for MenACWY-CRM than for MenACWY-D for all four serogroups. MenACWY-CRM was non-inferior to MenACWY-D for all serogroups, and superior for serogroup Y. In the 56-65 years age group, post-vaccination GMTs were 1.2-to 5.4-fold higher for MenACWY-CRM than for MPSV4 for the four serogroups. Conclusions: MenACWY-CRM is well tolerated and immunogenic in adults aged 19-65 years, with at least non-inferior immunogenicity compared with the currently licensed meningococcal vaccines.

Safety and immunogenicity of meningococcal ACWY CRM197-conjugate vaccine in children, adolescents and adults in Russia

“…25,26,28 In the adults, our results are in agreement with previous trials conducted in the US 30 and Latin America. 32 The observed percentage of responders 1 mo post-vaccination in these 2 studies was between 50% and 86% across serogroups, 30,32 which is similar to the observed 57% and 85% in our study. In addition, the percentage of subjects who achieved an hSBA titer ≥ 1:8 was between 69% and 98% across groups in the 2 previous trials, 30,32 and between 85% and 97% in ours.…”

Randomized Clinical Trial To Evaluate the Immunogenicity of Quadrivalent Meningococcal Conjugate and Polysaccharide Vaccines in Adults in the United Kingdom

“…hSBA titers Ն 4 have been established as the correlate of protection for serogroup C conjugate vaccines (3), indicating that both vaccines are likely to provide protection against serogroup C meningococcal disease. Although there are no validated correlates of protection for serogroups A, W, and Y, a titer value of Ն8 has been used as an endpoint in prelicensure immunogenicity studies of conjugate quadrivalent meningococcal vaccines in adults (4).…”

Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in healthy adolescents

“…[11][12][13] The results of clinical evaluations of MenACWY-CRM (Menveo Ò , Novartis Vaccines, Siena, Italy), a quadrivalent meningococcal oligosaccharide-CRM 197 conjugate vaccine, 9 demonstrate that this vaccine is highly immunogenic and well tolerated in a wide range of age populations beginning from 2 months of age. [14][15][16] MenACWY-CRM is currently licensed for use in children, adolescents and adults in many countries, including the US and countries in the EU, Latin America and Asia.…”