Immunogenicity and safety of MenACWY-TT, a quadrivalent meningococcal tetanus toxoid conjugate vaccine recently licensed in the United States for individuals ≥2 years of age

Abstract

Vaccination offers the best way to prevent invasive meningococcal disease (IMD). As demonstrated in countries with national immunization programs (NIPs) against IMD, meningococcal conjugate vaccines have contributed to significant declines in incidence. Since some meningococcal vaccines are associated with modest immunogenicity in infants, possible immunological interference upon concomitant administration with some pediatric vaccines, and administration errors resulting from improper reconstitution, opportunities for improvement exist. A quadrivalent conjugate vaccine, MenQuadfi® (Meningococcal [Serogroups A, C, Y, and W] Conjugate Vaccine; Sanofi, Swiftwater, Pennsylvania), was approved in 2020 for the prevention of IMD caused by meningococcal serogroups A, C, W, and Y in individuals ≥2 years of age in the United States. Five pivotal studies and one ancillary study supported approval in the United States; clinical trials in infants are ongoing. Data on the immunogenicity and safety of this vaccine are presented, and its potential value in clinical practice is discussed.

Keywords: IMD; Immunogenicity; MenACWY-CRM; MenACWY-D; MenACWY-TT; MenACYW-TT; MenQuadfi; invasive meningococcal disease; meningococcal conjugate vaccine; safety; vaccine recommendations.

Figure 1.

Immunogenicity findings of pivotal Phase II and Phase III studies of MenACWY-TT: Seroprotection rates based on post-vaccination Day 30 hSBA titers. The seroprotection rate was defined as the proportion of participants with post-vaccination hSBA titers ≥1:8. White bars depict data for MenACWY-TT and gray bars depict data for comparator vaccines.

Figure 2.

Immunogenicity findings of pivotal Phase II and Phase III studies of MenACWY-TT: Seroresponse rates based on post-vaccination Day 30 hSBA titers. The seroresponse rate was defined as the proportion of participants with post-vaccination hSBA titers ≥1:8 (for study MET50) and ≥1:16 (for all other studies) if pre-vaccination titers were <1:8 or with a ≥4-fold increase if pre-vaccination titers were ≥1:8. White bars depict data for MenACWY-TT and gray bars depict data for comparator vaccines.

Figure 3.

Immunogenicity findings of pivotal Phase II and Phase III studies of MenACWY-TT: Geometric means of hSBA titers on post-vaccination Day 30 in the per-protocol population. White bars depict data for MenACWY-TT and gray bars depict data for comparator vaccines.

Figure 4.

Immunogenicity of booster doses of MenACWY-TT among participants ≥15 years of age in Study MET56: seroprotection rates (top), seroresponse rates (middle), and GMTs (bottom) based on hSBA titers on post-vaccination Days 6 (left) and 30 (right) in the per-protocol population. White bars depict data for MenACWY-TT and gray bars depict data for MenACWY-D.

Figure 5.

Immunogenicity of MenACWY-TT across age groups among adults ≥56 years of age in Study MET49: hSBA seroresponse rates on post-vaccination Day 30 in the per-protocol population. White bars depict data for MenACWY-TT and gray bars depict data for MPSV4.