Protecting the most vulnerable age group: a review of MenACWY-TT immunogenicity and safety in infants.

INTRODUCTION: Neisseria meningitidis causes invasive meningococcal disease (IMD), with the highest incidence observed in infants and young children. Meningococcal serogroups A, B, C, W, X, and Y account for almost all IMD cases worldwide. Available meningococcal vaccines targeting serogroups A, C, W, and Y (MenACWY) include those conjugated to diphtheria toxoid (MenACWY-D), diphtheria protein cross-reactive material 197 (MenACWY-CRM197), and tetanus toxoid (MenACWY-TT). MenACWY-TT is indicated for use starting at 6 weeks of age. AREAS COVERED: This review discusses data from the four primary studies assessing MenACWY-TT safety and immunogenicity in infants, which evaluated a variety of dosing schedules, short-term and long-term outcomes, and impact of coadministration on the immunogenicity of routine childhood vaccines. Remaining gaps in the field are addressed. EXPERT OPINION: Robust data support the use of MenACWY-TT in infants starting as early as 6 weeks of age. MenACWY-TT was safe and well tolerated in infants, was immunogenic after priming and booster, and demonstrated persistent immunogenicity. Lower persistence for serogroup A relative to other serogroups based on serum bactericidal assays (SBAs) using human complement appears to be a class effect of MenACWY conjugate vaccines. Correlates of protection other than SBA are being explored, including immunologic responses associated with different carrier proteins.