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

January 29, 2019 updated by: Felipe Martinez, Universidad de Valparaiso

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile
        • Hospital Gustavo Fricke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serologic Response
Time Frame: 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.
4-8 weeks After Exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Reactions to Vaccine
Time Frame: One Week after Exposure
Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure.
One Week after Exposure
Systemic Reactions to the Vaccine
Time Frame: One Week after Exposure
Number of participants presenting any systemic adverse reaction attributable to vaccination.
One Week after Exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Valparaiso

Collaborators

GlaxoSmithKline
Roche Pharma AG
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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