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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Universidad de Valparaiso
Sponsor:
Collaborators:
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: December 5, 2013
Last verified: December 2013

December 2, 2013
December 5, 2013
December 2013
December 2014   (final data collection date for primary outcome measure)
Serologic Response [ Time Frame: 4-8 weeks After Exposure ] [ Designated as safety issue: No ]
Number of participants with positive hepatitis B surface antigen (HBsAg) antibodies 4 to 8 weeks after completion of the vaccination schemes.
Same as current
Complete list of historical versions of study NCT02003703 on ClinicalTrials.gov Archive Site
  • Local Reactions to Vaccine [ Time Frame: One Week after Exposure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of participants presenting any systemic adverse reaction attributable to vaccination.
Same as current
Not Provided
Not Provided
 
Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Hepatitis B
  • HIV
Biological: Recombinant Hepatitis B Virus Vaccine
Other Name: Engerix B (GlaxoSmithKline)
  • 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.
    Intervention: Biological: Recombinant Hepatitis B Virus Vaccine
  • 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.
    Intervention: Biological: Recombinant Hepatitis B Virus Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Jose I Vargas, MD 62473415 ext +56 9 jivargasd@icloud.com
Contact: Daniela Jensen, MD 62473409 ext +56 9 daniela_jensen@hotmail.com
Chile
 
NCT02003703
45/2012
No
Felipe Martinez, Universidad de Valparaiso
Universidad de Valparaiso
  • Roche Pharma AG
  • GlaxoSmithKline
  • Aclin Laboratories, Chile
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
Universidad de Valparaiso
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP