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

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV : A Randomised Trial

Conditions
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Hepatitis B, HIV

Intervention / Treatment
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* Biological: Recombinant Hepatitis B Virus Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant Hepatitis B Virus Vaccine (High Dose)<br>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<br> <br> * Other names: Engerix B (GlaxoSmithKline);|
| Active Comparator: Recombinant Hepatitis B Virus Vaccine (Standard Dose)<br>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<br> <br> * Other names: Engerix B (GlaxoSmithKline);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serologic Response | Number of participants with positive hepatitis B surface antigen (HBsAg) antibodies 4 to 8 weeks after completion of the vaccination schemes. | 4-8 weeks After Exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Reactions to Vaccine | Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure. | One Week after Exposure | 
| Systemic Reactions to the Vaccine | Number of participants presenting any systemic adverse reaction attributable to vaccination. | One Week after Exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Prevention, Immunogenicity, Vaccine