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Trial record 7 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
Verified October 2016 by Felipe Martinez, Universidad de Valparaiso
Sponsor:
ClinicalTrials.gov Identifier:
NCT02003703
First Posted: December 6, 2013
Last Update Posted: October 25, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Roche Pharma AG
GlaxoSmithKline
Aclin Laboratories, Chile
Information provided by (Responsible Party):
Felipe Martinez, Universidad de Valparaiso
  Purpose
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 Intervention Phase
Hepatitis B HIV Biological: Recombinant Hepatitis B Virus Vaccine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Felipe Martinez, Universidad de Valparaiso:

Primary Outcome Measures:
  • 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:
  • 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.

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


Estimated Enrollment: 150
Study Start Date: May 2015
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


Contacts
Contact: Jose I Vargas, MD 62473415 ext +56 9 jivargasd@icloud.com
Contact: Daniela Jensen, MD 62473409 ext +56 9 daniela_jensen@hotmail.com

Locations
Chile
Hospital Gustavo Fricke Recruiting
Viña del Mar, Valparaíso, Chile
Contact: Jose I Vargas, MD    62473415 ext +56 9    jivargasd@icloud.com   
Contact: Daniela Jensen, MD    62473409 ext +56 9    daniela_jensen@hotmail.com   
Principal Investigator: Jose I Vargas, MD         
Principal Investigator: Daniela Jensen, MD         
Principal Investigator: Francisco Fuster, MD         
Principal Investigator: Valeska Sarmiento         
Sponsors and Collaborators
Universidad de Valparaiso
Roche Pharma AG
GlaxoSmithKline
Aclin Laboratories, Chile
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
  More Information

Responsible Party: Felipe Martinez, MD, Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT02003703     History of Changes
Other Study ID Numbers: 45/2012
First Submitted: December 2, 2013
First Posted: December 6, 2013
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by Felipe Martinez, Universidad de Valparaiso:
Vaccine
Primary Prevention
Immunogenicity

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Virus Diseases
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs