title: Three doses of an experimental detoxified L3-derived lipooligosaccharide meningococcal vaccine offer good safety but low immunogenicity in healthy young adults.
abstract: This open, randomized phase I study evaluated the safety and reactogenicity of an experimental meningococcal serogroup B (MenB) vaccine obtained from outer membrane vesicle detoxified L3-derived lipooligosaccharide. Healthy young adults (n = 150) were randomized to receive either experimental vaccine (provided in five formulations, n = 25 in each group) or VA-Mengoc-BC (control, n = 25) administered on a 0- to 6-week/6-month schedule. Serum bactericidal assays performed against three MenB wild-type strains assessed the immune response, defined as a 4-fold increase from pre- to postvaccination. No serious adverse events related to vaccination were reported. Pain at the injection site, fatigue, and headache were the most commonly reported adverse events. Solicited adverse events graded level 3 (i.e., preventing daily activity) were pain (up to 17% of the test subjects versus 32% of the controls), fatigue (up to 12% of the test subjects versus 8% of the controls), and headache (up to 4% of any group). Swelling graded level 3 (greater than 50 mm) occurred in up to 4% of the test subjects versus 8% of the controls. The immune responses ranged from 5% to 36% across experimental vaccines for the L3 H44-76 strain (versus 27% for the control), from 0% to 11% for the L3 NZ98/124 strain (versus 23% for the control), and from 0% to 13% for the L2 760676 strain (versus 59% for the control). All geometric mean titers were below those measured with the control vaccine. The five experimental formulations were safe and well tolerated but tended to be less immunogenic than the control vaccine.
authors.affiliation: Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina.
authors.forename: Pablo
authors.initials: P
authors.lastname: Bonvehí
authors.forename: Dominique
authors.initials: D
authors.lastname: Boutriau
authors.forename: Javier
authors.initials: J
authors.lastname: Casellas
authors.forename: Vincent
authors.initials: V
authors.lastname: Weynants
authors.forename: Christiane
authors.initials: C
authors.lastname: Feron
authors.forename: Jan
authors.initials: J
authors.lastname: Poolman
mesh_terms: D000293:Adolescent; D000328:Adult; D064420:Drug-Related Side Effects and Adverse Reactions; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006261:Headache / Q000139:chemically induced; D006805:Human Experimentation; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods*; D008070:Lipopolysaccharides / Q000009:adverse effects* / Q000276:immunology*; D008297:Male; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D038541:Neisseria meningitidis, Serogroup B / Q000276:immunology; D010146:Pain / Q000139:chemically induced; D022142:Secretory Vesicles / Q000276:immunology; D058248:Serum Bactericidal Antibody Assay; D012871:Skin Diseases / Q000139:chemically induced / Q000473:pathology; D014611:Vaccination / Q000379:methods*; D055815:Young Adult
chemical_list: D008070:Lipopolysaccharides; D022401:Meningococcal Vaccines; C023023:lipid-linked oligosaccharides