Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study
Abstract Introduction Many immunization programs in Europe recommend quadrivalent meningococcal vaccinations, which are often administered concomitantly with other vaccines. We compared the immune response of a tetanus toxoid conjugated quadrivalent meningococcal vaccine (MenACYW-TT, MenQuadfi®) wit...
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Adis, Springer Healthcare
2024-07-01
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| Series: | Infectious Diseases and Therapy |
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| Online Access: | https://doi.org/10.1007/s40121-024-01009-x |
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| author | Javier Díez-Domingo Róbert Simkó Giancarlo Icardi Chan Poh Chong Céline Zocchetti Olga Syrkina Siham Bchir Isabelle Bertrand-Gerentes |
| author_facet | Javier Díez-Domingo Róbert Simkó Giancarlo Icardi Chan Poh Chong Céline Zocchetti Olga Syrkina Siham Bchir Isabelle Bertrand-Gerentes |
| author_sort | Javier Díez-Domingo |
| collection | DOAJ |
| description | Abstract Introduction Many immunization programs in Europe recommend quadrivalent meningococcal vaccinations, which are often administered concomitantly with other vaccines. We compared the immune response of a tetanus toxoid conjugated quadrivalent meningococcal vaccine (MenACYW-TT, MenQuadfi®) with another quadrivalent meningococcal conjugate vaccine (MCV4-TT; Nimenrix®) when administered alone or concomitantly with Tdap-IPV and 9vHPV vaccines in adolescents. Methods In this phase IIIb trial, healthy adolescents (MenC-naïve or MenC-primed before 2 years of age) from Spain, Italy, Hungary, and Singapore were randomized in a 3:3:2 ratio to receive either MenACYW-TT or MCV4-TT alone, or MenACYW-TT concomitantly with 9vHPV and Tdap-IPV. The primary objective was to demonstrate the non-inferiority of the seroprotection rate (human serum bactericidal assay [hSBA] titer ≥ 1:8) to serogroups A, C, W, and Y 30 days post-vaccination with a single dose of MenACYW-TT or MCV4-TT. Secondary objectives included describing hSBA titers for the four serogroups before and 1 month following vaccination and according to MenC priming status. Results A total of 463 participants were enrolled (MenACYW-TT, n = 173; MCV4-TT, n = 173; MenACYW-TT/9vHPV/Tdap-IPV n = 117). Non-inferiority based on seroprotection was demonstrated for MenACYW-TT versus MCV4-TT for all serogroups. Immune responses were comparable whether MenACYW-TT was administered alone or concomitantly with Tdap-IPV and 9vHPV. Post-vaccination hSBA GMTs were higher in MenACYW-TT vs. MCV4-TT for serogroups C, Y, and W and comparable for serogroup A. The percentages of participants with an hSBA vaccine seroresponse were higher in MenACYW-TT vs. MCV4-TT for all serogroups. For serogroup C, higher GMTs were observed in both MenC-naïve or -primed participants vaccinated with MenACYW-TT vs. MCV4-TT. Seroprotection and seroresponse were higher in MenC-naïve participants vaccinated with MenACYW-TT vs. MCV4-TT and comparable in MenC-primed. The safety profiles were comparable between groups and no new safety concerns were identified. Conclusions These data support the concomitant administration of MenACYW-TT with 9vHPV and Tdap-IPV vaccines in adolescents. Trial Registrations Clinicaltrials.gov, NCT04490018; EudraCT: 2020-001665-37; WHO: U1111-1249-2973. |
| format | Article |
| id | doaj-art-cbdd7a3b1f1b4cb08a6700d6e9fd6174 |
| institution | DOAJ |
| issn | 2193-8229 2193-6382 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | Adis, Springer Healthcare |
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| series | Infectious Diseases and Therapy |
| spelling | doaj-art-cbdd7a3b1f1b4cb08a6700d6e9fd61742025-08-20T03:15:12ZengAdis, Springer HealthcareInfectious Diseases and Therapy2193-82292193-63822024-07-011381835185910.1007/s40121-024-01009-xImmunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter StudyJavier Díez-Domingo0Róbert Simkó1Giancarlo Icardi2Chan Poh Chong3Céline Zocchetti4Olga Syrkina5Siham Bchir6Isabelle Bertrand-Gerentes7Vaccine Research Department, FISABIOFuturenest Clin. Res. LtdDepartment of Health Sciences, University of Genoa-Hygiene Unit, San Martino Policlinico HospitalDepartment of Paediatrics, KTP-National University Children’s Medical Institute, National University HospitalIsabelle Betrand-Gerentes, Global MedicalPatient Safety and Pharmacovigilance, Sanofi R&DGlobal Biostatistical Sciences, Sanofi VaccinesIsabelle Betrand-Gerentes, Global MedicalAbstract Introduction Many immunization programs in Europe recommend quadrivalent meningococcal vaccinations, which are often administered concomitantly with other vaccines. We compared the immune response of a tetanus toxoid conjugated quadrivalent meningococcal vaccine (MenACYW-TT, MenQuadfi®) with another quadrivalent meningococcal conjugate vaccine (MCV4-TT; Nimenrix®) when administered alone or concomitantly with Tdap-IPV and 9vHPV vaccines in adolescents. Methods In this phase IIIb trial, healthy adolescents (MenC-naïve or MenC-primed before 2 years of age) from Spain, Italy, Hungary, and Singapore were randomized in a 3:3:2 ratio to receive either MenACYW-TT or MCV4-TT alone, or MenACYW-TT concomitantly with 9vHPV and Tdap-IPV. The primary objective was to demonstrate the non-inferiority of the seroprotection rate (human serum bactericidal assay [hSBA] titer ≥ 1:8) to serogroups A, C, W, and Y 30 days post-vaccination with a single dose of MenACYW-TT or MCV4-TT. Secondary objectives included describing hSBA titers for the four serogroups before and 1 month following vaccination and according to MenC priming status. Results A total of 463 participants were enrolled (MenACYW-TT, n = 173; MCV4-TT, n = 173; MenACYW-TT/9vHPV/Tdap-IPV n = 117). Non-inferiority based on seroprotection was demonstrated for MenACYW-TT versus MCV4-TT for all serogroups. Immune responses were comparable whether MenACYW-TT was administered alone or concomitantly with Tdap-IPV and 9vHPV. Post-vaccination hSBA GMTs were higher in MenACYW-TT vs. MCV4-TT for serogroups C, Y, and W and comparable for serogroup A. The percentages of participants with an hSBA vaccine seroresponse were higher in MenACYW-TT vs. MCV4-TT for all serogroups. For serogroup C, higher GMTs were observed in both MenC-naïve or -primed participants vaccinated with MenACYW-TT vs. MCV4-TT. Seroprotection and seroresponse were higher in MenC-naïve participants vaccinated with MenACYW-TT vs. MCV4-TT and comparable in MenC-primed. The safety profiles were comparable between groups and no new safety concerns were identified. Conclusions These data support the concomitant administration of MenACYW-TT with 9vHPV and Tdap-IPV vaccines in adolescents. Trial Registrations Clinicaltrials.gov, NCT04490018; EudraCT: 2020-001665-37; WHO: U1111-1249-2973.https://doi.org/10.1007/s40121-024-01009-xInvasive meningococcal diseaseVaccinationImmunogenicitySafetyMenACYW-TTMCV4-TT |
| spellingShingle | Javier Díez-Domingo Róbert Simkó Giancarlo Icardi Chan Poh Chong Céline Zocchetti Olga Syrkina Siham Bchir Isabelle Bertrand-Gerentes Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study Infectious Diseases and Therapy Invasive meningococcal disease Vaccination Immunogenicity Safety MenACYW-TT MCV4-TT |
| title | Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study |
| title_full | Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study |
| title_fullStr | Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study |
| title_full_unstemmed | Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study |
| title_short | Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study |
| title_sort | immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine versus nimenrix in healthy adolescents a randomized phase iiib multicenter study |
| topic | Invasive meningococcal disease Vaccination Immunogenicity Safety MenACYW-TT MCV4-TT |
| url | https://doi.org/10.1007/s40121-024-01009-x |
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