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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00440297
First received: February 26, 2007
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Hepatitis B Virus Infection
Biological: Comparator: modified process hepatitis B vaccine
Biological: Comparator: ENGERIX-B™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7 [ Time Frame: 7 months (1 month after the third dose) ] [ Designated as safety issue: No ]

    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).


  • 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) ] [ Designated as safety issue: No ]

    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).


  • The Total Number of Participants With One or More Injection-Site Adverse Experiences [ Time Frame: Days 1-5 After Any Vaccination ] [ Designated as safety issue: Yes ]
  • The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C [ Time Frame: Days 1-5 After Any Vaccination ] [ Designated as safety issue: Yes ]
  • The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences [ Time Frame: 0-9 months (recorded from first dose until the participant completes or discontinues the study) ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 276
Study Start Date: December 2006
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Modified process hepatitis B vaccine
Biological: 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.
Active Comparator: 2
ENGERIX-B™
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) approximately 2 weeks before the initial dose of study vaccine
  • Patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of <=20 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440297

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00440297     History of Changes
Other Study ID Numbers: V232-060, 2007_515
Study First Received: February 26, 2007
Results First Received: March 24, 2009
Last Updated: April 30, 2014
Health Authority: Canada: Health Canada

Keywords provided by Merck Sharp & Dohme Corp.:
hepatitis B virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Encephalitis, Herpes Simplex
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
Herpesviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014