2725. Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Adolescents and Adults

Abstract

BackgroundThe MenACYW-TT conjugate vaccine is a quadrivalent meningococcal vaccine that contains tetanus toxoid as carrier protein. Vaccine is intended for global use in all age groups (i.e., individuals 6 weeks of age and older). This Phase III study evaluated the safety and immunogenicity of the vaccine when compared with a licensed quadrivalent meningococcal conjugate vaccine in individuals ≥ 15 years of age.MethodsA randomized, modified double-blind study (NCT02752906) was conducted in the United States and Puerto Rico. The study evaluated 810 participants primed with a licensed quadrivalent meningococcal conjugate vaccine (Menactra® [MenACWY-D] or MENVEO® [MenACWY-CRM]) in the 4 to 10 years prior to enrollment. Participants were randomly assigned to receive either a single booster dose of MenACYW-TT conjugate vaccine or MenACWY-D. Safety data were collected up to 6 months post-vaccination.ResultsNon-inferiority of immune response was demonstrated for MenACYW-TT vs. MenACWY-D based on percentages of participants achieving an serum bactericidal assay with human complement (hSBA) seroresponse for serogroups A, C, W, and Y at Day 30 post-vaccination. Post-vaccination hSBA geometric mean titers (GMTs) were higher following administration of MenACYW-TT compared with MenACWY-D for age subgroups ≥15 to < 18 years and ≥18 years. Relative to MenACWY-D, post-vaccination hSBA GMTs were higher for all 4 serogroups following administration of MenACYW-TT in participants who received the priming vaccine < 7 years prior to the booster; for participants who received priming vaccine ≥7 years prior to booster, post-vaccination GMTs were higher for serogroups C, W and Y, and comparable for serogroup A. In MenACWY-CRM-primed subjects, hSBA vaccine seroresponse rates were comparable for all 4 serogroups regardless of the booster vaccine administered. In MenACWY-D-primed subjects, hSBA seroresponse rates following MenACYW-TT booster administration were comparable for serogroups A and Y, and higher for serogroups C and W. Reactogenicity profiles were comparable across study groups.ConclusionMenACYW-TT conjugate vaccine was immunogenic and well tolerated when administered as a booster dose to individuals ≥15 years of age.Disclosures All authors: No reported disclosures.