TY - JOUR
T1 - Comparing the meningococcal serogroup C immune response elicited by a tetanus toxoid conjugate quadrivalent meningococcal vaccine (MenACYW-TT) versus a quadrivalent or monovalent C tetanus toxoid conjugate meningococcal vaccine in healthy meningococcal vaccine-naïve toddlers
T2 - A randomised, controlled trial
AU - Knuf, Markus
AU - Rämet, Mika
AU - Breinholt Stærke, Nina
AU - Bertrand-Gerentes, Isabelle
AU - Thollot, Yaël
AU - B'Chir, Siham
AU - Arroum, Habiba
AU - Oster, Philipp
N1 - Funding Information:
The authors wish to thank the participants and their parents, the investigators, coordinators and their site staff, the team at Public Health England and GCI laboratories, and the Sanofi Pasteur study team responsible for the design and coordination of the study, particularly to Bertrand Lassalvy and Mae Ann Verdan. Editorial assistance with the preparation of the manuscript was provided by Chandara Olgunsoy MSc and Nicola Truss PhD, inScience Communications, Springer Healthcare Ltd, London, UK. Funding for this assistance was provided by Sanofi Pasteur. The authors would like to thank Jean-Sébastien Persico for editorial assistance and manuscript coordination on behalf of Sanofi Pasteur.
Publisher Copyright:
© 2022 The Author(s). Published with license by Taylor & Francis Group, LLC.
PY - 2022
Y1 - 2022
N2 - MenACYW-TT (MenQuadfi®) is a quadrivalent meningococcal tetanus toxoid conjugate vaccine licensed in Europe for use in individuals ≥12 months. This study assessed whether serogroup C immune responses with MenACYW-TT were at least non-inferior, or superior, to those of quadrivalent meningococcal ACWY (MCV4-TT; Nimenrix®) and monovalent meningococcal C (MenC-TT; NeisVac-C®) vaccines in toddlers (12–23 months). In this modified, double-blind Phase III study (NCT03890367), 701 toddlers received one dose of MenACYW-TT (n = 230), MCV4-TT (n = 232) or MenC-TT (n = 239). Serum bactericidal assays with human (hSBA) and baby rabbit (rSBA) complement were used to measure anti-meningococcal serogroup C antibodies at baseline and 30 days post-vaccination. A sequential statistical approach was used for primary and secondary objectives. For the primary objectives, superiority of serogroup C was assessed in terms of hSBA seroprotection rates (defined as titers ≥1:8) and GMTs for MenACYW-TT compared to MCV4-TT, and rSBA GMTs compared to MenC-TT. The safety of all vaccines within 30 days post-vaccination was described. When administered as a single dose to meningococcal vaccine-naïve healthy toddlers the superiority of the MenACYW-TT serogroup C immune response versus MCV4-TT was demonstrated for hSBA GMTs (ratio 16.3 [12.7–21.0]) and seroprotection (difference 10.43% [5.68–16.20]); and versus MenC-TT in terms of rSBA GMTs (ratio 1.32 [1.06–1.64]). The safety profiles of a single dose of MenACYW-TT, MCV4-TT and MenC-TT were similar. In meningococcal vaccine-naïve toddlers, MenACYW-TT induced superior immune responses to serogroup C versus MCV4-TT in terms of hSBA seroprotection and GMTs and versus MenC-TT in terms of rSBA GMTs.
AB - MenACYW-TT (MenQuadfi®) is a quadrivalent meningococcal tetanus toxoid conjugate vaccine licensed in Europe for use in individuals ≥12 months. This study assessed whether serogroup C immune responses with MenACYW-TT were at least non-inferior, or superior, to those of quadrivalent meningococcal ACWY (MCV4-TT; Nimenrix®) and monovalent meningococcal C (MenC-TT; NeisVac-C®) vaccines in toddlers (12–23 months). In this modified, double-blind Phase III study (NCT03890367), 701 toddlers received one dose of MenACYW-TT (n = 230), MCV4-TT (n = 232) or MenC-TT (n = 239). Serum bactericidal assays with human (hSBA) and baby rabbit (rSBA) complement were used to measure anti-meningococcal serogroup C antibodies at baseline and 30 days post-vaccination. A sequential statistical approach was used for primary and secondary objectives. For the primary objectives, superiority of serogroup C was assessed in terms of hSBA seroprotection rates (defined as titers ≥1:8) and GMTs for MenACYW-TT compared to MCV4-TT, and rSBA GMTs compared to MenC-TT. The safety of all vaccines within 30 days post-vaccination was described. When administered as a single dose to meningococcal vaccine-naïve healthy toddlers the superiority of the MenACYW-TT serogroup C immune response versus MCV4-TT was demonstrated for hSBA GMTs (ratio 16.3 [12.7–21.0]) and seroprotection (difference 10.43% [5.68–16.20]); and versus MenC-TT in terms of rSBA GMTs (ratio 1.32 [1.06–1.64]). The safety profiles of a single dose of MenACYW-TT, MCV4-TT and MenC-TT were similar. In meningococcal vaccine-naïve toddlers, MenACYW-TT induced superior immune responses to serogroup C versus MCV4-TT in terms of hSBA seroprotection and GMTs and versus MenC-TT in terms of rSBA GMTs.
KW - immunogenicity
KW - invasive meningococcal disease
KW - MCV4-TT
KW - MenACYW-TT
KW - MenC-TT
KW - meningococcal serogroup C
KW - non-inferiority
KW - seroprotection
KW - superiority
KW - toddlers
U2 - 10.1080/21645515.2022.2052657
DO - 10.1080/21645515.2022.2052657
M3 - Article
C2 - 35445641
AN - SCOPUS:85129655003
SN - 2164-5515
VL - 18
JO - HUMAN VACCINES & IMMUNOTHERAPEUTICS
JF - HUMAN VACCINES & IMMUNOTHERAPEUTICS
IS - 5
M1 - 2052657
ER -
