Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study.

Autor: Zambrano B; Global Clinical Development Strategy, Sanofi, Montevideo, Uruguay., Peterson J; J. Lewis Research, Salt Lake City, UT, USA., Deseda C; Caribbean Travel Medicine Clinic, San Juan, Puerto Rico., Julien K; J. Lewis Research Inc, South Jordan, UT, USA., Spiegel CA; Craig A. Spiegel, MD Bridgeton, Bridgeton, MO, USA., Seyler C; Pediatric Clinical Trials Tullahoma, Tullahoma, TN, USA., Simon M; Michael W. Simon, MD, PSC, Lexington, KY, USA., Hoki R; Wee Care Pediatrics, Layton, UT, USA., Anderson M; Tanner Clinic, Layton, UT, USA., Brabec B; Midwest Children's Health Research Institute, Lincoln, NE, USA., Áñez G; Global Clinical Development Strategy, Sanofi, Swiftwater, PA, USA., Shi J; Global Biostatistical Sciences, Sanofi, Swiftwater, PA, USA., Pan J; Global Biostatistical Sciences, Sanofi, Swiftwater, PA, USA., Hagenbach A; Sanofi, Marcy L'Étoile, France., Von Barbier D; Sanofi, Swiftwater, PA, USA., Varghese K; Global Clinical Immunology, Sanofi, Swiftwater, PA, USA., Jordanov E; Global Clinical Development Strategy, Sanofi, Swiftwater, PA, USA., Dhingra MS; Global Clinical Development Strategy, Sanofi, Swiftwater, PA, USA. MandeepSingh.Dhingra@sanofi.com.
Jazyk: angličtina
Zdroj: Pediatric research [Pediatr Res] 2023 Sep; Vol. 94 (3), pp. 1035-1043. Date of Electronic Publication: 2023 Mar 10.
DOI: 10.1038/s41390-023-02478-5
Abstrakt: Background: The immunogenicity and safety of a booster dose of tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT), alone or co-administered with MenB vaccine, were assessed in healthy 13-25-year olds who received MenACYW-TT or a CRM-conjugate vaccine (MCV4-CRM) 3-6 years earlier.
Methods: This phase IIIb open-label trial (NCT04084769) evaluated MenACYW-TT-primed participants, randomized to receive MenACYW-TT alone or with a MenB vaccine, and MCV4-CRM-primed participants who received MenACYW-TT alone. Functional antibodies against serogroups A, C, W and Y were measured using human complement serum bactericidal antibody assay (hSBA). The primary endpoint was vaccine seroresponse (post-vaccination titers ≥1:16 if pre-vaccination titers <1:8; or a ≥4-fold increase if pre-vaccination titers ≥1:8) 30 days post booster. Safety was evaluated throughout the study.
Results: The persistence of the immune response following primary vaccination with MenACYW-TT was demonstrated. Seroresponse after MenACYW-TT booster was high regardless of priming vaccine (serogroup A: 94.8% vs 93.2%; C: 97.1% vs 98.9%; W: 97.7% vs 98.9%; and Y; 98.9% vs 100% for MenACWY-TT-primed and MCV4-CRM-primed groups, respectively). Co-administration with MenB vaccines did not affect MenACWY-TT immunogenicity. No vaccine-related serious adverse events were reported.
Conclusions: MenACYW-TT booster induced robust immunogenicity against all serogroups, regardless of the primary vaccine received, and had an acceptable safety profile.
Impact: A booster dose of MenACYW-TT induces robust immune responses in children and adolescents primed with MenACYW-TT or another MCV4 (MCV4-DT or MCV4-CRM), respectively. Here, we demonstrate that MenACYW-TT booster 3-6 years after primary vaccination induced robust immunogenicity against all serogroups, regardless of the priming vaccine (MenACWY-TT or MCV4-CRM), and was well tolerated. Persistence of the immune response following previous primary vaccination with MenACYW-TT was demonstrated. MenACYW-TT booster with MenB vaccine co-administration did not affect MenACWY-TT immunogenicity and was well tolerated. These findings will facilitate the provision of broader protection against IMD particularly in higher-risk groups such as adolescents.
(© 2023. The Author(s).)
Databáze: MEDLINE
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