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CORE-HIV: Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .

Sponsor
Universidad de Valparaiso (Other)
Overall Status
Completed
CT.gov ID
NCT02003703
Collaborator
Roche Pharma AG (Industry), GlaxoSmithKline (Industry), Aclin Laboratory (Other)
107
Enrollment
1
Location
2
Arms
43
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. The purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one.

Condition or Disease Intervention/Treatment Phase
  • Biological: Recombinant Hepatitis B Virus Vaccine
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV : A Randomised Trial
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Recombinant Hepatitis B Virus Vaccine (High Dose)

Patients allocated to this arm will receive three doses of 40mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.

Biological: Recombinant Hepatitis B Virus Vaccine
Other Names:
  • Engerix B (GlaxoSmithKline)

    		•
    Active Comparator: Recombinant Hepatitis B Virus Vaccine (Standard Dose)

    Patients allocated to this arm will receive three doses of 20mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.

    Biological: Recombinant Hepatitis B Virus Vaccine
    Other Names:
  • Engerix B (GlaxoSmithKline)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serologic Response [4-8 weeks After Exposure]

      Number of participants with positive hepatitis B surface antigen (HBsAg) antibodies 4 to 8 weeks after completion of the vaccination schemes.

    Secondary Outcome Measures

    1. Local Reactions to Vaccine [One Week after Exposure]

      Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure.

    2. Systemic Reactions to the Vaccine [One Week after Exposure]

      Number of participants presenting any systemic adverse reaction attributable to vaccination.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Older than 18 years of age.

    • Patients infected with Human Immunodeficiency Virus (HIV)

    • Failed previous vaccination with a standard dose scheme of recombinant hepatitis B vaccine (20mcg at 0, 1 and 6 months). Nonresponders will be considered as those patients presenting a hepatitis B surface antigen antibody titer lower than 10UI/mL 4 to 8 weeks after the last dose of the vaccine.

    • Provision of informed consent.

    Exclusion Criteria:

    • Proven Hepatitis B virus infection (acute or chronic).

    • Proven hypersensitivity to the vaccine or any of its components.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Gustavo Fricke Viña del Mar Valparaíso Chile

    Sponsors and Collaborators

    • Universidad de Valparaiso
    • Roche Pharma AG
    • GlaxoSmithKline
    • Aclin Laboratory

    Investigators

    • Principal Investigator: Francisco Fuster, MD, Hospital Gustavo Fricke, Viña del Mar, Chile
    • Principal Investigator: Jose I Vargas, MD, Escuela de Medicina, Universidad de Valparaíso, Chile
    • Principal Investigator: Daniela Jensen, MD, Escuela de Medicina, Universidad de Valparaíso
    • Principal Investigator: Felipe T Martinez, MD, Centro de Investigaciones Biomédicas, Escuela de Medicina, Universidad de Valparaíso

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Felipe Martinez, MD, Universidad de Valparaiso
    ClinicalTrials.gov Identifier:
    NCT02003703
    Other Study ID Numbers:
    • 45/2012
    First Posted:
    Dec 6, 2013
    Last Update Posted:
    Jan 31, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Felipe Martinez, MD, Universidad de Valparaiso
    Vaccine
    Primary Prevention
    Immunogenicity
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Virus Diseases
    Herpesviridae Infections
    Hepatitis

    Study Results

    No Results Posted as of Jan 31, 2019