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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B Virus Infection

Treatments: Biological: Comparator: modified process hepatitis B vaccine; Biological: Comparator: ENGERIX-B™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00440297

2007_515 (Other Identifier)

V232-060

Details and patient eligibility

About

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

Enrollment: 277 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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277 participants in 2 patient groups

Modified process hepatitis B vaccine

Experimental group

Description:

Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.

Treatment:

Biological: Comparator: modified process hepatitis B vaccine

ENGERIX-B™2

Active Comparator group

Description:

ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.

Treatment:

Biological: Comparator: ENGERIX-B™