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

Phase 3CompletedNCT02003703

Universidad de Valparaiso107 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

107

Conditions

Hepatitis B HIV

Interventions

Recombinant Hepatitis B Virus VaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Gustavo Fricke

Viña del Mar, Valparaiso, Chile

Outcomes

Primary Outcomes

Serologic Response

Number of participants with positive hepatitis B surface antigen (HBsAg) antibodies 4 to 8 weeks after completion of the vaccination schemes.

Time frame: 4-8 weeks After Exposure

Secondary Outcomes

Local Reactions to Vaccine

Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure.

Time frame: One Week after Exposure

Systemic Reactions to the Vaccine

Number of participants presenting any systemic adverse reaction attributable to vaccination.

Time frame: One Week after Exposure

Data from ClinicalTrials.gov

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