Clinical Trials

MainTitle

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. (see Contacts and Locations)

Verified October 2016 by Felipe Martinez, Universidad de Valparaiso

Sponsor
Universidad de Valparaiso

Collaborator
Roche Pharma AG
GlaxoSmithKline
Aclin Laboratories, Chile

Information provided by (Responsible Party)
Felipe Martinez, Universidad de Valparaiso

ClinicalTrials.gov Identifier
NCT02003703

First received: December 2, 2013
Last updated: October 24, 2016
Last Verified: October 2016
History of Changes
Purpose

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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information


Responsible Party: Felipe Martinez, MD, Universidad de Valparaiso  
ClinicalTrials.gov Identifier: NCT02003703   History of Changes  
Other Study ID Numbers: 45/2012  
Study First Received: December 2, 2013  
Last Updated: October 24, 2016  

Keywords provided by Felipe Martinez, Universidad de Valparaiso:

Vaccine
Primary Prevention
Immunogenicity

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Virus Diseases
Vaccines

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.