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

Universidad de Valparaiso

Status and phase: Completed; Phase 3

Conditions: HIV; Hepatitis B

Treatments: Biological: Recombinant Hepatitis B Virus Vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02003703

45/2012

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups

Recombinant Hepatitis B Virus Vaccine (High Dose)

Experimental group

Description:

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.

Treatment:

Biological: Recombinant Hepatitis B Virus Vaccine

Recombinant Hepatitis B Virus Vaccine (Standard Dose)

Active Comparator group

Description:

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.

Treatment:

Biological: Recombinant Hepatitis B Virus Vaccine