Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in healthy adolescents.
Hum Vaccin Immunother
; 11(6): 1507-17, 2015.
Article
em En
| MEDLINE
| ID: mdl-25969894
ABSTRACT
This phase 2 study assessed the immunogenicity, safety, and reactogenicity of investigational formulations of meningococcal ABCWY vaccines, consisting of recombinant proteins (rMenB) and outer membrane vesicle (OMV) components of a licensed serogroup B vaccine, combined with components of a licensed quadrivalent meningococcal glycoconjugate vaccine (MenACWY-CRM). A total of 495 healthy adolescents were randomized to 6 groups to receive 2 doses (Months 0, 2) of one of 4 formulations of rMenB antigens, with or without OMV, combined with MenACWY-CRM, or 2 doses of rMenB alone or one dose of MenACWY-CRM then a placebo. Immunogenicity was assessed by serum bactericidal assay with human complement (hSBA) against serogroups ACWY and serogroup B test strains; solicited reactions and any adverse events (AEs) were assessed. Two MenABCWY vaccinations elicited robust ACWY immune responses, with higher seroresponse rates than one dose of MenACWY-CRM. Bactericidal antibody responses against the rMenB antigens and OMV components were highest in subjects who received 2 doses of OMV-containing MenABCWY formulations, with ≥68% of subjects achieving hSBA titers ≥5 against each of the serogroup B test strains. After the first dose, solicited local reaction rates were higher in the MenABCWY or rMenB groups than the MenACWY-CRM group, but similar across groups after the second dose, consisting mainly of transient injection site pain. Fever (≥38.0°C) was rare and there were no vaccine-related serious AEs. In conclusion, investigational MenABCWY formulations containing OMV components elicited highly immunogenic responses against meningococcal serogroups ACWY, as well as serogroup B test strains, with an acceptable safety profile. [NCT01210885].
Palavras-chave
AE, adverse event; CI, confidence interval; GMT, geometric mean titer; IMD, invasive meningococcal disease; NHBA, Neisserial Heparin Binding Antigen; NadA, Neisseria adhesin A; Neisseria meningitidis; OMV, outer membrane vesicle; PP, per-protocol set; SAE, serious adverse event; adolescents; conjugate vaccine; fHbp, factor H-binding protein; hSBA, serum bactericidal assay with human complement; immunogenicity; meningococcal disease; safety
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Drogas em Investigação
/
Vacinas Meningocócicas
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Hum Vaccin Immunother
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
Panamá