Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
Primary Purpose
Hepatitis B Virus Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: modified process hepatitis B vaccine
Comparator: ENGERIX-B™
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B Virus Infection focused on measuring hepatitis B virus
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Modified process hepatitis B vaccine
ENGERIX-B™2
Arm Description
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™ 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.
Outcomes
Primary Outcome Measures
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).
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).
The Total Number of Participants With One or More Injection-Site Adverse Experiences
The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00440297
First Posted
February 26, 2007
Last Updated
March 16, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00440297
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Virus Infection
Keywords
hepatitis B virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
277 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified process hepatitis B vaccine
Arm Type
Experimental
Arm Description
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.
Arm Title
ENGERIX-B™2
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Comparator: modified process hepatitis B vaccine
Intervention Description
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
Intervention Name(s)
Comparator: ENGERIX-B™
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7
Description
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)
Title
The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9
Description
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).
Time Frame
9 months (1 month after the fourth dose)
Title
The Total Number of Participants With One or More Injection-Site Adverse Experiences
Time Frame
Days 1-15 After Any Vaccination
Title
The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C
Time Frame
Days 1-5 After Any Vaccination
Title
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
25252192
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.
Results Reference
result
Learn more about this trial
Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
We'll reach out to this number within 24 hrs