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

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

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

Conditions
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Hepatitis B Virus Infection

Intervention / Treatment
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* Biological: Comparator: modified process hepatitis B vaccine
* Biological: Comparator: ENGERIX-B™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified process hepatitis B vaccine<br>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. | Biological: Comparator: modified process hepatitis B vaccine<br>* 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.<br>|
| Active Comparator: ENGERIX-B™2<br>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. | Biological: Comparator: ENGERIX-B™<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7 | The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose). | 7 months (1 month after the third dose) | 
| The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9 | The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose). | 9 months (1 month after the fourth dose) | 
| The Total Number of Participants With One or More Injection-Site Adverse Experiences |  | Days 1-15 After Any Vaccination | 
| The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C |  | Days 1-5 After Any Vaccination | 
| The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences | Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose). | 0-9 months (recorded from first dose until the participant completes or discontinues the study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis B virus