Antibody Persistence at 1 and 4 Years Following a Single Dose of MenAfriVac or Quadrivalent Polysaccharide Vaccine in Healthy Subjects Aged 2-29 Years.
Clin Infect Dis
; 61 Suppl 5: S521-30, 2015 Nov 15.
Article
en En
| MEDLINE
| ID: mdl-26553684
ABSTRACT
BACKGROUND:
Mass vaccination campaigns of the population aged 1-29 years with 1 dose of group A meningococcal (MenA) conjugate vaccine (PsA-TT, MenAfriVac) in African meningitis belt countries has resulted in the near-disappearance of MenA. The vaccine was tested in clinical trials in Africa and in India and found to be safe and highly immunogenic compared with the group A component of the licensed quadrivalent polysaccharide vaccine (PsACWY). Antibody persistence in Africa and in India was investigated.METHODS:
A total of 900 subjects aged 2-29 years were followed up for 4 years in Senegal, Mali, and The Gambia (study A). A total of 340 subjects aged 2-10 years were followed up for 1 year in India (study B). In study A, subjects were randomized in a 21 ratio, and in study B a 11 ratio to receive either PsA-TT or PsACWY. Immunogenicity was evaluated by measuring MenA serum bactericidal antibody (SBA) with rabbit complement and by a group A-specific immunoglobulin G (IgG) enzyme-linked immunosorbent assay.RESULTS:
In both studies, substantial SBA decay was observed at 6 months postvaccination in both vaccine groups, although more marked in the PsACWY group. At 1 year and 4 years (only for study A) postvaccination, SBA titers were relatively sustained in the PsA-TT group, whereas a slight increasing trend, more pronounced among the youngest, was observed in the participants aged <18 years in the PsACWY groups. The SBA titers were significantly higher in the PsA-TT group than in the PsACWY group at any time point, and the majority of subjects in the PsA-TT group had SBA titers ≥128 and group A-specific IgG concentrations ≥2 µg/mL at any point in time in both the African and Indian study populations.CONCLUSIONS:
Four years after vaccination with a single dose of PsA-TT vaccine in Africa, most subjects are considered protected from MenA disease. CLINICAL TRIALS REGISTRATION PsA-TT-003 (ISRCTN87739946); PsA-TT-003a (ISRCTN46335400).Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Actividad Bactericida de la Sangre
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Vacunas Meningococicas
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Anticuerpos Antibacterianos
Tipo de estudio:
Clinical_trials
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Observational_studies
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Prognostic_studies
Límite:
Adolescent
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Adult
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Animals
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Child
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Child, preschool
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Female
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Humans
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Male
País/Región como asunto:
Africa
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Asia
Idioma:
En
Revista:
Clin Infect Dis
Asunto de la revista:
DOENCAS TRANSMISSIVEIS
Año:
2015
Tipo del documento:
Article