Clinical trial NCT00440297: Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
Official title: A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B Virus Infection
Keywords: hepatitis B virus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7
timeFrame: 7 months (1 month after the third dose)
measure: The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9
timeFrame: 9 months (1 month after the fourth dose)
measure: The Total Number of Participants With One or More Injection-Site Adverse Experiences
timeFrame: Days 1-15 After Any Vaccination
measure: The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C
timeFrame: Days 1-5 After Any Vaccination
measure: The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
timeFrame: 0-9 months (recorded from first dose until the participant completes or discontinues the study)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gilbert CL, Stek JE, Villa G, Klopfer SO, Martin JC, Schodel FP, Bhuyan PK. Safety and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in renal pre-dialysis and dialysis patients. Vaccine. 2014 Nov 12;32(48):6521-6. doi: 10.1016/j.vaccine.2014.09.015. Epub 2014 Sep 22.