Adjuvanted hepatitis B vaccine: new drug. Patients with renal failure: similar response rate but fewer boosters needed.
(1) Dialysis patients are at high risk of contracting hepatitis B. As standard hepatitis B vaccines are weakly immunogenic in patients with severe renal failure, it is necessary to give more injections or to double the normal vaccine dose at each vaccination session; (2) Fendrix is a hepatitis B vaccine containing the adjuvant AS04C. It is sold in a dozen European countries. No comparative trials with clinical outcome measures have been conducted, only an immunogenicity study focusing on adverse effects; (3) This study included 165 patients over 15 years of age with severe renal failure (creatinine clearance less than or greater than 30 ml/min). Some of the patients were on dialysis. The study compared a single dose of the adjuvanted hepatitis B vaccine versus double doses of Engerix B vaccine (40 micrograms of viral surface antigen) given at each vaccination session. Three months after the first injection the proportion of patients with "protective" antibody titres (at least 10 mlU/ml) was statistically higher in the adjuvant group (74.4% versus 52.4%). Seven months after the first injection, however, a similar proportion of patients in the two groups had "protective" titres (about 90%); (4) 109 of the patients were then monitored for three years, and immunity was found to last longer in the adjuvant group (72.9% versus 52% of patients); (5) Pain at the injection site occurred in respectively 41% and 13% of patients treated with the adjuvanted vaccine and Engerix. A papillomavirus vaccine containing adjuvant AS04C has also been found to cause more local reactions, including pain; (6) The only practical advantages of the adjuvanted hepatitis B vaccine are that immunity is achieved a little more rapidly and that the interval between boosters is somewhat longer.
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017607:Aluminum Compounds / Q000276:immunology / Q000627:therapeutic use; D017277:Drug Approval; D005060:Europe; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D006801:Humans; D007110:Immunity, Active; D007676:Kidney Failure, Chronic / Q000188:drug therapy / Q000276:immunology; D011135:Polysaccharides, Bacterial / Q000276:immunology / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D006435:Renal Dialysis / Q000009:adverse effects; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000276:Adjuvants, Immunologic; D017607:Aluminum Compounds; D017325:Hepatitis B Vaccines; D011135:Polysaccharides, Bacterial; D017778:Vaccines, Combined