Trial | NCT02003703  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    107
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 Started
May 31
2015
Primary Completion
Jun 30
2018
Study Completion
Dec 31
2018
Last Update
Jan 31
2019

Biological Recombinant Hepatitis B Virus Vaccine

  • Other names: Engerix B (GlaxoSmithKline)

Recombinant Hepatitis B Virus Vaccine (High Dose) Experimental

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.

Recombinant Hepatitis B Virus Vaccine (Standard Dose) Active Comparator

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.

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.
No Results Posted