Abstract
ABSTRACT The quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) was assessed as a booster in this Phase III trial (NCT02752906). Quadrivalent meningococcal conjugate vaccine (MCV4)-primed individuals aged ≥15 y (n = 810) were randomized 1:1 to receive a single booster dose of MenACYW-TT (n = 403) or a licensed MCV4 (Menactra®; MCV4-DT [n = 407]). Serum bactericidal antibody assay with human complement (hSBA) was used to measure functional antibodies against serogroups A, C, W, and Y at baseline and Day 30 post-vaccination. Proportions of participants achieving seroresponse (post-vaccination titer ≥1:16 for those with baseline titer <1:8 or ≥4-fold increase in post-vaccination titer for those with baseline titer ≥1:8) were determined. Safety data were collected for 180 d post-vaccination. Non-inferiority of the immune response was demonstrated for MenACYW-TT compared with MCV4-DT based on the proportion of participants achieving hSBA vaccine seroresponse for each of the meningococcal serogroups at Day 30. Moreover, ≥99% of participants in both study groups had hSBA titers ≥1:8 for the four meningococcal serogroups at Day 30. Reactogenicity profiles were comparable between groups. These Phase III data in adolescents and adults show that MenACYW-TT boosts the immune response in those primed with MCV4 vaccines 4–10 y previously, irrespective of whether MCV4-DT or MCV4-CRM was used for priming.
Highlights
Neisseria meningitidis, a Gram-negative diplococcus, is exclusively pathogenic for humans
The study was planned to have more than 99.9% power to declare the non-inferiority of the MenACYW-TT seroresponse to that of MCV4-DT based on hSBA antibody titers elicited against each serogroup
All immunogenicity analyses were performed on the perprotocol analysis set (PPAS), which is a subset of the full analysis set with no major protocol deviations
Summary
A Gram-negative diplococcus, is exclusively pathogenic for humans. The course of infection with N. meningitidis is often rapid, where patients can develop invasive meningococcal disease (IMD), and succumb to the infection in just a few hours. Survivors frequently suffer sequelae that can range from limb necrosis requiring amputation to cognitive impairment.[1,2,3] There are 12 serogroups of N. meningitidis, classified according to their capsular polysaccharide composition. Serogroups A, B, C, W, X, and Y are the most prevalent cause of IMD worldwide; the geographical distribution of the serogroups is dynamic and varies by region.[4] The epidemiological pattern of IMD necessitates the use of multivalent meningococcal vaccines that provide protection against a wide range of disease-causing serogroups
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
