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

Phase 3

Completed

• Conditions: Hepatitis B; HIV
• Interventions: Biological: Recombinant Hepatitis B Virus Vaccine

• Registration Number: NCT02003703
• Lead Sponsor: Universidad de Valparaiso

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-06
• Study Start: 2015-05
• Primary Completion: 2018-06
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant Hepatitis B Virus Vaccine (High Dose)	Recombinant Hepatitis B Virus Vaccine	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)	Recombinant Hepatitis B Virus Vaccine	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.

Primary Outcome Measures

Name	Time	Method
Serologic Response	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

Name	Time	Method
Systemic Reactions to the Vaccine	One Week after Exposure	Number of participants presenting any systemic adverse reaction attributable to vaccination.
Local Reactions to Vaccine	One Week after Exposure	Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure.

Trial Locations

Locations (1)

Hospital Gustavo Fricke; 🇨🇱 Viña del Mar, Valparaíso, Chile