Hepatitis B Vaccine in Patients Receiving Hemodialysis

Abstract

We evaluated the immunogenicity and efficacy of hepatitis B vaccine (Heptavax-B) in a randomized, double-blind, placebo-controlled trial involving 1311 patients receiving hemodialysis in the United States. After three doses of vaccine (40 micrograms each) had been administered, 63 per cent of the patients were antibody-positive. After correction for possible passive transfer of antibodies by blood transfusion, only 50 per cent of vaccine recipients were considered vaccine responders. The incidence of hepatitis B viral infection during the 25 months of the trial was much lower than had been anticipated and was virtually the same in the vaccine and placebo recipients (6.4 and 5.4 per cent, respectively). Four cases of hepatitis B occurred in patients who had an apparent antibody response to the vaccine, but in each case either antibody had reached low or undetectable levels before hepatitis B surface antigen was detected or the patient had been receiving immunosuppressive therapy. This study did not demonstrate the efficacy of the vaccine in a population of patients receiving dialysis in whom both the rate of antibody response to hepatitis B vaccine and the viral attack rate were low. Other measures to control transmission of hepatitis B virus in dialysis units, including surveillance for hepatitis B surface antigen and isolation of patients who are positive for the antigen, must be continued.

Immunogenicity in humans of an edible vaccine for hepatitis B

“…It is relevant that use of the commercial HBsAg parenteral vaccine, which does include an adjuvant (alum), does not always lead to successful immunization. Nonresponsiveness remains a problem for a group of vaccinees (18)(19)(20)(21), and booster vaccination to maintain protective titer levels has been discussed (22,23). Moreover, oral delivery in human subjects of a recombinant adenovirus containing the HBsAg gene failed to stimulate serum anti-HBs (24), although that construct may have been compromised by deletion of an important adenovirus gene.…”

Review article: prevention and management of hepatitis B and C infection in patients with inflammatory bowel disease

“…81 However, among haemodialysis patients who responded to the vaccine, clinically significant HBV infection has been documented in those who did not maintain antiHBs concentrations >10 mIU ⁄ mL. 112 Therefore, immunocompromised patients could need annual testing to assess anti-HBs concentrations. 81 For example, for haemodialysis patients, the need for booster doses should be assessed by annual anti-HBs testing.…”

Intradermal Recombinant Hepatitis B Vaccine for Healthcare Workers Who Fail to Respond to Intramuscular Vaccine

“…1,2 However, approximately 12% of HCWs who receive primary intramuscular vaccination fail to develop protective hepatitis B surface antibody (anti-HBs) concentrations (у 10 mIU/mL) 3,4 and remain at risk of occupationally acquired HBV infection. 5 Risk factors for vaccine nonresponse include male gender, older age, cigarette smoking, 3,4 renal failure, 6 intragluteal vaccine administration, 7 and certain HLA haplotypes. 8 The optimal management of HCWs who fail to respond to primary intramuscular vaccination is unclear.…”