title: Safety and immunogenicity of meningococcal ACWY CRM197-conjugate vaccine in children, adolescents and adults in Russia.
abstract: Neisseria meningitidis is the leading cause of bacterial invasive infections in people aged <15 years in the Russian Federation. The aim of this phase III, multicenter, open-label study was to assess the immunogenicity and safety of the quadrivalent meningococcal CRM197-conjugate vaccine MenACWY when administered to healthy Russian subjects aged 2 years and above. A total of 197 subjects were immunized with a single dose of the vaccine, and serogroup-specific serum bactericidal activity was measured pre and 1-month post-vaccination with human complement (hSBA) serum titers. Regardless of baseline serostatus, 1 month after a single dose of MenACWY-CRM197 85% (95%CI, 79-90%) of subjects showed serologic response against serogroup A, 74% (67-80%) against serogroup C, 60% (53-67%) against serogroup W, and 83% (77-88%) against serogroup Y. The percentage of subjects with hSBA titers ≥ 1:8 1 month after vaccination was 89% (83-93%) against serogroup A, 84% (78-89%) against serogroup C, 97% (93-99%) against serogroup W, and 88% (82-92%) against serogroup Y. Comparable results were obtained across all subjects: children (2 to 10 years), adolescents (11 to 17 years), and adults (≥18 years). The MenACWY-CRM197 vaccine showed an acceptable safety profile and was well tolerated across all age groups, with no serious adverse events or deaths reported during the study. In conclusion, a single dose of meningococcal MenACWY-CRM197 vaccine is immunogenic and has an acceptable safety profile, provides a broad protection against the most frequent epidemic serogroups, and is a suitable alternative to currently available unconjugated monovalent or bivalent polysaccharide vaccines in Russia.
authors.affiliation: a Federal State Budgetary Institution "State Scientific Center "Institution of Immunology" of the Russian Federal Biomedical Agency"; Moscow, Russia.
authors.forename: Natalia
authors.initials: N
authors.lastname: Ilyina
authors.forename: Susanna
authors.initials: S
authors.lastname: Kharit
authors.forename: Leila
authors.initials: L
authors.lastname: Namazova-Baranova
authors.forename: Asmik
authors.initials: A
authors.lastname: Asatryan
authors.forename: Mayya
authors.initials: M
authors.lastname: Benashvili
authors.forename: Elmira
authors.initials: E
authors.lastname: Tkhostova
authors.forename: Chiranjiwi
authors.initials: C
authors.lastname: Bhusal
authors.forename: Ashwani Kumar
authors.initials: AK
authors.lastname: Arora
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001770:Blood Bactericidal Activity; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D064368:Healthy Volunteers; D006801:Humans; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D008875:Middle Aged; D038381:Neisseria meningitidis, Serogroup A / Q000276:immunology; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology; D038582:Neisseria meningitidis, Serogroup W-135 / Q000276:immunology; D038581:Neisseria meningitidis, Serogroup Y / Q000276:immunology; D012426:Russia; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: C556088:MenACWY-CRM vaccine; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate
keywords: CRM197-conjugate; Russia; adolescent; adult; children; immunogenicity; meningococcal; quadrivalent vaccine; safety