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

Hepatitis B Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440297
• Other study ID #: V232-060
• Secondary ID: 2007_515
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2007
• Last updated: October 29, 2015
• Start date: December 2006
• Est. completion date: May 2008

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Virus Infection
• Virus Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Gilbert CL, Stek JE, Villa G, Klopfer SO, Martin JC, Schödel 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	7 months (1 month after the third dose)	No
Primary	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).	9 months (1 month after the fourth dose)	No
Primary	The Total Number of Participants With One or More Injection-Site Adverse Experiences		Days 1-15 After Any Vaccination	Yes
Primary	The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C		Days 1-5 After Any Vaccination	Yes
Primary	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).	0-9 months (recorded from first dose until the participant completes or discontinues the study)	Yes