Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)

A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients

Inclusion Criteria:

• Male and female subjects at least 18 years of age
• Laboratory confirmed negative serology result to HbsAg (hepatitis b virus), anti-HBs (antibody to hepatitis B surface antigen), and anti HBc (antibody to hepatitis B core antigen) within 6 weeks of the initial dose of study vaccine
• Patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of <=30 ml/min

Exclusion Criteria:

• Previous hepatitis B infection, vaccination with any hepatitis B vaccine
• Recent febrile illness; hypersensitivity to any component of licensed hepatitis B vaccines
• Recent administration of immune globulin, licensed inactivated vaccine within 14 days or licensed live vaccine within 30 days prior to receipt of first study vaccine
• Receipt of investigational drugs or investigational vaccines within 3 months prior
• Impairment of immunologic function
• Recent use of systemic immunomodulatory medications
• Pregnant women, nursing mothers or women planning to become pregnant