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

NCT00440297 | Completed Phase 3 Results

• 2 other identifiers: V232-0602007_515
• Study Type: interventional
• Target: 277
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatitis B Virus Infection

Keywords

hepatitis B virus

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• The Total Number of Participants With One or More Injection-Site Adverse Experiences

  Days 1-15 After Any Vaccination

• The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C

  Days 1-5 After Any Vaccination

• 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)

Study Arms (2)

Modified process hepatitis B vaccine

EXPERIMENTAL

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.

Biological: Comparator: modified process hepatitis B vaccine

ENGERIX-B™2

ACTIVE COMPARATOR

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.

Biological: Comparator: ENGERIX-B™

Interventions

Comparator: modified process hepatitis B vaccine BIOLOGICAL

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.

Modified process hepatitis B vaccine

Comparator: ENGERIX-B™ BIOLOGICAL

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.

ENGERIX-B™2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 25252192 RESULT

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Vice President, Late Stage Development Group Leader
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 27, 2007
• Study Start: December 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 13, 2017
• Results First Posted: July 8, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share