Long-term immunogenicity of preservative-free hepatitis B vaccine formulations in adults.
J Med Virol
; 81(10): 1710-5, 2009 Oct.
Article
em En
| MEDLINE
| ID: mdl-19697416
ABSTRACT
Vaccination with recombinant hepatitis B vaccines is highly effective in preventing hepatitis B infection. Recently, a preservative-free (PF) formulation of hepatitis B vaccine [GlaxoSmithKline (GSK) Biologicals, Rixensart, Belgium] has been licensed. The immunogenicity of the PF hepatitis B vaccine and antibody persistence 6 years later was assessed in this study. This formulation was compared with the preservative- containing (PC) formulation of the vaccine and a low-preservative (LP) content formulation. Five hundred forty-one healthy adult subjects were evaluated in the primary study. Over 94% of the subjects in the three study groups had seroprotective anti-HBs antibody concentrations (>or=10 mIU/ml) 1 month after completing primary vaccination. Antibody measurements in 242 healthy adults who returned for the follow-up study and who had received primary vaccination 6 years earlier showed that over 81% of subjects in the three study groups still had anti-HBs antibody concentrations >or=10 mIU/ml. No apparent differences in antibody decline or distribution between the study groups were observed. These results indicate that the removal of preservatives from the hepatitis B vaccine does not affect adversely its immunogenicity both in the short and in the longer term.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Conservantes Farmacêuticos
/
Vacinas contra Hepatite B
Tipo de estudo:
Observational_studies
/
Prognostic_studies
Limite:
Adolescent
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Adult
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Female
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Humans
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Male
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Middle aged
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2009
Tipo de documento:
Article