Hepatitis B Vaccine Predialysis/Dialysis Study
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00440297
First received: February 26, 2007
Last updated: April 20, 2010
Last verified: April 2010
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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:
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00440297 History of Changes |
| Other Study ID Numbers: | 2007_515, V232-060 |
| Study First Received: | February 26, 2007 |
| Results First Received: | March 24, 2009 |
| Last Updated: | April 20, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Merck:
|
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 June 18, 2013