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Clinical Trial
. 2020 Jun 9;38(28):4405-4411.
doi: 10.1016/j.vaccine.2020.04.067. Epub 2020 May 6.

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in ≥56-year-olds: A Phase III randomized study

Alejandra Esteves-Jaramillo  1 , Timothy Koehler  2 , Robert Jeanfreau  3 , David Neveu  4 , Emilia Jordanov  5 , Mandeep Singh Dhingra  6
Affiliations
Free article
Clinical Trial

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in ≥56-year-olds: A Phase III randomized study

Alejandra Esteves-Jaramillo et al. Vaccine. .
Free article

Abstract

Background: Invasive meningococcal disease has a high mortality rate in individuals aged ≥56 years, but no vaccine is currently licensed in the USA for this age group. This study assessed the safety and immunogenicity of an investigational quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACYW-TT) compared with a meningococcal quadrivalent polysaccharide vaccine (MPSV4) in this age group.

Methods: This was a Phase III, modified double-blind, randomized, non-inferiority study (NCT02842866) across 35 clinical sites in the USA and Puerto Rico in individuals aged ≥56 years. A single dose of the MenACYW-TT (n = 451) or MPSV4 vaccine (n = 455) was administered on Day 0. A serum bactericidal assay with human (hSBA) and baby rabbit (rSBA) complement was used to measure antibodies against serogroups A, C, W, and Y test strains at baseline and Day 30. Safety data were collected up to six months post-vaccination.

Results: The seroresponse to MenACYW-TT was non-inferior to MPSV4 for each of the serogroups (A: 58.2% vs. 42.5%; C: 77.1% vs. 49.7%; W: 62.6% vs. 44.8%, Y: 74.4% vs. 43.4%, respectively). At Day 30, participants achieving hSBA titers ≥1:8 were higher for all serogroups after MenACYW-TT vs. MPSV4 (77.4-91.7 vs. 63.1-84.2%, respectively). No safety concerns were identified for either vaccine.

Conclusion: MenACYW-TT was well-tolerated and immunogenic in ≥56-year-olds, offering the potential to replace MPSV4 in this age group.

Keywords: Bacterial meningitis; Invasive meningococcal disease; MPSV4; MenACYW-TT; Vaccine.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AEJ, DN, EJ, and MSD are employees of Sanofi Pasteur. MSD and EJ hold stock options for Sanofi Pasteur. TK is an employee of Heartland Research Associates which was under contract to Sanofi Pasteur to conduct this research, and RJ is an employee of MedPharmics which was under contract to Sanofi Pasteur to conduct this research.

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