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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003703
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
Roche Pharma AG
GlaxoSmithKline
Aclin Laboratory
Information provided by (Responsible Party):
Felipe Martinez, Universidad de Valparaiso

Study Description
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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
Hepatitis B HIV Biological: Recombinant Hepatitis B Virus Vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Engerix B (GlaxoSmithKline)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Systemic Reactions to the Vaccine [ Time Frame: One Week after Exposure ]
    Number of participants presenting any systemic adverse reaction attributable to vaccination.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003703


Locations
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Chile
Hospital Gustavo Fricke
Viña del Mar, Valparaíso, Chile
Sponsors and Collaborators
Universidad de Valparaiso
Roche Pharma AG
GlaxoSmithKline
Aclin Laboratory
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Felipe Martinez, MD, Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT02003703    
Other Study ID Numbers: 45/2012
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Keywords provided by Felipe Martinez, Universidad de Valparaiso:
Vaccine
Primary Prevention
Immunogenicity
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Virus Diseases
Herpesviridae Infections
Hepatitis
Infections
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections