Rapid, enhanced, and persistent protection of patients with renal insufficiency by AS02(V)-adjuvanted hepatitis B vaccine
Murielle Surquin, Christian L Tielemans, Imre Kulcsár, Miroslav Ryba, Péter Vörös, Olivier Mat, Serge Treille, Michel Dhaene, Jean-Claude Stolear, Sherine O Kuriyakose, Maarten X Leyssen, Sophie A Houard
DOI: 10.1038/ki.2009.454
Klíčová slova: Adjuvants, Immunologic, Adolescent, Adult, Aged, Antibodies, Viral, Female, Hepatitis B, Hepatitis B Vaccines, Humans, Male, Middle Aged, Renal Dialysis, Renal Insufficiency, Time Factors, Treatment Outcome, Young Adult
Anotace: The adjuvanted hepatitis B vaccine, HB-AS04, elicits more rapid and persistent protective antibody concentrations than double doses of conventional recombinant vaccines in patients with renal insufficiency. We compared the immunogenicity, reactogenicity, and safety of the AS02(V)-adjuvanted hepatitis B vaccine HB-AS02 with that of HB-AS04. In this phase III, open, randomized study, 151 hepatitis B vaccine-naïve pre-dialysis, peritoneal dialysis, and hemodialysis patients aged 15 years and older received three doses of HB-AS02 at 0, 1, and 6 months. Another 149 similar patients received four doses of HB-AS04 at 0, 1, 2, and 6 months, and all were followed up for 12 months. HB-AS02 elicited more rapid and persistent seroprotection than HB-AS04, with rates of 77 and 39%, respectively, 1 month after the second vaccine dose, and 94 and 79%, respectively, at 12 months. Superiority of HB-AS02 over HB-AS04 in anti-hepatitis B geometric mean concentrations was found at all time points. HB-AS02 was more reactogenic than HB-AS04, but adverse events were mainly transient, of mild to moderate intensity with no reportable vaccine-related serious events. We conclude that a three-dose primary course of HB-AS02 induced more rapid, enhanced, and persistent protection in patients with renal insufficiency than the licensed four-dose primary schedule of HB-AS04. This adjuvanted vaccine affords greater protection with reduced need for booster doses in patients at high risk of hepatitis B infection.
Citace: SURQUIN, Murielle, Christian L TIELEMANS, Imre KULCSÁR, et al. Rapid, enhanced, and persistent protection of patients with renal insufficiency by AS02(V)-adjuvanted hepatitis B vaccine. Kidney international. 2010, 77(3), 247-255. ISSN 15231755. Dostupné z: doi:10.1038/ki.2009.454