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Completed

NCT Number: NCT00440297

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

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

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

    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).

  2. 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)

    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).

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

    Time frame: Days 1-15 After Any Vaccination

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

    Time frame: Days 1-5 After Any Vaccination

  5. 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)

    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).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 27, 2007
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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