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

Merck Sharp & Dohme LLC277 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

277

Conditions

Hepatitis B Virus Infection

Interventions

Comparator: modified process hepatitis B vaccineBIOLOGICAL

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.

Comparator: ENGERIX-B™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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: 9 months (1 month after the fourth dose)

The Total Number of Participants With One or More Injection-Site Adverse Experiences

Time frame: Days 1-15 After Any Vaccination

The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C

Time frame: 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).

Time frame: 0-9 months (recorded from first dose until the participant completes or discontinues the study)

Data from ClinicalTrials.gov

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