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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

NCT00699231

Hepatitis B

COMPLETED PHASE1

Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

NCT00440531

Hepatitis B

COMPLETED PHASE3

Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

NCT02963714

Hepatitis B Vaccine

COMPLETED PHASE4

Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population

NCT03962881

Hepatitis B Vaccine

UNKNOWN PHASE4

A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.

NCT00291941

Hepatitis B

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis B Virus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Modified process hepatitis B vaccine

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.

Group Type EXPERIMENTAL

Comparator: modified process hepatitis B vaccine

Intervention Type BIOLOGICAL

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.

ENGERIX-B™2

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.

Group Type ACTIVE_COMPARATOR

Comparator: ENGERIX-B™

Intervention Type BIOLOGICAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Comparator: modified process hepatitis B vaccine

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.

Intervention Type BIOLOGICAL

Comparator: ENGERIX-B™

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No