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

NCT02003703

CompletedPhase 3

Sponsor: Universidad de Valparaiso

Conditions: Hepatitis B, HIV

Interventions: Recombinant Hepatitis B Virus Vaccine

Countries: Chile

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Viña del Mar, Valparaiso, Chile