Five-Year Immune Persistence of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) and Immunogenicity and Safety of a Booster Dose in Children

被引:0
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作者
Martinon-Torres, Federico [1 ,2 ,3 ,4 ]
Simko, Robert [5 ]
Ebert, Rolf [6 ]
Ramet, Mika [7 ,8 ]
Zocchetti, Celine [9 ]
Syrkina, Olga [10 ]
Bchir, Siham [11 ]
Bertrand-Gerentes, Isabelle [9 ]
机构
[1] Hosp Clin Univ Santiago SERGAS, Translat Pediat & Infect Dis, Santiago De Compostela, Galicia, Spain
[2] Univ Santiago de Compostela, Santiago De Compostela, Galicia, Spain
[3] Inst Invest Sanitaria Santiago De Compostela, Genet Vaccines Infect & Pediat Res Grp GENVIP, Santiago De Compostela, Galicia, Spain
[4] Inst Salud Carlos III, Ctr Invest Biomed Red Enfermedades Respiratorias, CIBERES, Madrid 28029, Spain
[5] Futurenest Clin Res, Miskolc, Hungary
[6] Ebert & Huebener Kinder & Jugendmed, Tauberbischofsheim, Germany
[7] Tampere Univ, Finnish Vaccine Res Ltd, Tampere, Finland
[8] Tampere Univ, Fac Med & Hlth Technol, Tampere, Finland
[9] Sanofi Vaccines, Global Med, 14 Espace Henry Vallee, F-69007 Lyon, France
[10] Sanofi R&D, Patient Safety & Pharmacovigilance, Cambridge, MA USA
[11] Global Biostat Sci, Sanofi Vaccines, Marcy Letoile, France
关键词
Booster dose; Children; Immune persistence; Invasive meningococcal disease; MenACYW-TT; Toddlers; Vaccine; ANTIBODY PERSISTENCE; SEROGROUP; W-135;
D O I
10.1007/s40121-025-01121-6
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
Introduction: Many countries recommend vaccination against Neisseria meningitidis serogroups A, C, W, and Y in infants and young children to prevent invasive meningococcal disease. We evaluated the immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) booster in children primed with the same meningococcal vaccine 5 years earlier. Immune persistence following priming vaccination was also evaluated, and the study is ongoing to generate 10 years' post-priming data. Methods: Healthy children, vaccinated with MenACYW-TT 5 years earlier as toddlers, were enrolled. Participants were randomized to receive MenACYW-TT booster (group 1) or no booster (group 2), stratified by country and meningococcal serogroup C (MenC) vaccination status (primed at age <= 1 year vs. naive). Antibodies against each serogroup were measured by serum bactericidal assay using human complement (hSBA). Seroresponse sufficiency at 30 days post-booster was demonstrated if the lower limit of the one-sided 97.5% confidence interval (CI) of the seroresponse rate (proportion of participants with post-vaccination titers >= 1:16 when baseline titers were < 1:8 or with a >= fourfold increase when baseline titers were >= 1:8) was > 75% for each serogroup. Seroprotection rates (proportion with hSBA titers >= 1:8) and geometric mean titers (GMTs) for each serogroup were also assessed. Results: A total of 209 participants were enrolled across 26 sites in Finland, Germany, Hungary, and Spain (group 1, n = 93; group 2, n = 116). Five years post-priming, GMTs, and seroprotection rates were higher than those observed before priming vaccination in both groups, indicating long-term persistence. Booster seroresponse rates in group 1 for all serogroups ranged from 93.2% to 98.9%, with seroresponse sufficiency demonstrated (lower limit of one-sided 97.5% CIs for the seroresponse rates ranging from 85.7% to 93.8%). Seroprotection rates and GMTs post-booster increased across all serogroups, with nearly all participants seroprotected, suggesting adequate booster response. Seroresponse was comparable between MenC-primed and MenC-naive participants. No new safety concerns were identified. Conclusions: MenACYW-TT provides long-term immune persistence and a robust immune response when administered as a booster in children primed 5 years earlier.
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页数:20
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