Review of clinical studies comparing meningococcal serogroup C immune responses induced by MenACWY-TT and monovalent serogroup C vaccines

Serra, Lidia; Knuf, Markus; Martinón-Torres, Federico; Yi, Kevin; Findlow, Jamie

doi:10.1080/21645515.2020.1855952

Cited by 9 publications

(3 citation statements)

References 46 publications

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“…Before this study, the only studies in naïve toddlers of Men C responses were between MCV4-TT and a CRM197 conjugated monovalent serogroup C vaccine. 24 , 25 As the MenC-TT vaccine is known to have increased immunogenicity compared to CRM conjugated vaccines, MenC-TT was proposed as a control for this study.…”

Section: Discussionmentioning

confidence: 99%

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: A randomised, controlled trial

Knuf

Rämet

Stærke

et al. 2022

Human Vaccines & Immunotherapeutics

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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.

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Section: Discussionmentioning

confidence: 99%

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: A randomised, controlled trial

Knuf

Rämet

Stærke

et al. 2022

Human Vaccines & Immunotherapeutics

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“…The serogroup Y cases have varied regarding the most affected age group, and commonly manifest as septicemia and with decreased penicillin susceptibility [75,76]. Importantly, several countries worldwide have introduced MenACWY vaccination to their immunization programs in response to this changing epidemiology [82], emphasizing that a single vaccine that provides protection against the 5 predominant diseasecausing serogroups could best address the variable epidemiology of IMD for at-risk populations.…”

Section: Dynamic Nature Of Meningococcal Disease Epidemiologymentioning

confidence: 99%

Rationale for the Development of a Pentavalent Meningococcal Vaccine: A US-Focused Review

2022

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While invasive meningococcal disease (IMD) is uncommon, it can result in serious sequelae and even death. In 2018 in the United States, the incidence of IMD per 100,000 people was 0.03 among adolescents 11-15 years of age, 0.10 among persons 16-23 years of age, and 0.83 among infants\1 year of age. Serogroup B accounted for 86%, 62%, and 66% of cases, respectively, in those age groups. Currently, routine meningococcal vaccination covering serogroups ACWY (MenACWY) is recommended in the United States for all adolescents at 11-12 years of age, with a booster dose at 16 years of age, whereas a meningococcal serogroup B (MenB) vaccine series is recommended for persons 16-23 years of age under the shared clinical decision-making paradigm.The MenACWY vaccination program in adolescents has been successful in reducing disease burden, but does not prevent disease caused by serogroup B, which accounts for more than half of IMD cases. There are currently no approved vaccines that cover all of the most common disease-causing meningococcal serogroups, which are A, B, C, W, and Y. A pentavalent MenABCWY vaccine that is constituted from 2 licensed meningococcal vaccines-MenB-FHbp and MenACWY-TT-is being investigated in healthy persons C 10-25years of age. The addition of a MenABCWY vaccine is the next natural step in the incremental meningococcal immunization program in the United States to improve protection against the most common serogroup causing IMD, with no increase in the number of immunizations needed. With high uptake, routine use of MenABCWY could reduce IMD cases and associated mortality, the rate of long-term physical and psychosocial sequelae in survivors, and costs associated with controlling outbreaks, particularly on college campuses. A MenABCWY vaccine would also reduce the number of injections required for adolescents, potentially improving compliance.

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“…In response, vaccination recommendations have been revised, with quadrivalent meningococcal conjugate vaccines being recommended in place of monovalent serogroup C conjugate vaccines in several countries [48]. This recommended replacement of monovalent conjugate vaccines is supported by data on immunogenicity and persistence of immune responses with quadrivalent conjugate vaccines for the C component that are comparable to those of the monovalent serogroup C conjugate vaccines [96,97]. In this regard, seroprotection rates against serogroup C have been shown to be higher with MenACYW-TT than with MCV4-TT [60,61], with this trend also being observed in studies wherein MCV4-D or MCV4-CRM were used as comparators [62][63][64][65].…”

Section: Expert Opinionmentioning

confidence: 99%

A novel vaccine to prevent meningococcal disease beyond the first year of life: an early review of MenACYW-TT

Martinón-Torres

Bertrand-Gerentes

Oster

2021

Expert Review of Vaccines

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Introduction: Although quadrivalent meningococcal conjugate vaccines have been effective in preventing invasive meningococcal disease (IMD) caused by serogroups A, C, W, and Y across age groups from infants to adults, data on their efficacy and safety in adults ≥56 years of age are lacking. Moreover, multiple available quadrivalent conjugate vaccines require reconstitution prior to administration, introducing the potential for error. A novel quadrivalent meningococcal conjugate vaccine, MenACYW-TT (MenQuadfi ® ) was approved in 2020 for use in individuals ≥12 months of age as a single dose in the European Union and some other countries and in individuals ≥2 years of age in the United States. Areas covered: The findings of Phase II/III studies that included >6600 individuals and evaluated the immunogenicity and safety of MenACYW-TT beyond the first year of life are comprehensively summarized and discussed. Expert opinion: Extensive data on immunogenicity and safety, co-administration with routine vaccines, elicitation of robust booster responses, and significantly higher Men C responses versus monovalent MenC or MenACWY standard-of-care vaccines in toddlers suggest that MenACYW-TT may be suitable for inclusion in National Immunization Programs (NIPs) globally. The authors provide their perspectives on the clinical use of MenACYW-TT across age groups from toddlers through adults.

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Review of clinical studies comparing meningococcal serogroup C immune responses induced by MenACWY-TT and monovalent serogroup C vaccines

Cited by 9 publications

References 46 publications

Rationale for the Development of a Pentavalent Meningococcal Vaccine: A US-Focused Review

A novel vaccine to prevent meningococcal disease beyond the first year of life: an early review of MenACYW-TT

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