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

Condition(s) targeted: Hepatitis B; HIV

Intervention: Recombinant Hepatitis B Virus Vaccine (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Universidad de Valparaiso

Official(s) and/or principal investigator(s):
Francisco Fuster, MD, Principal Investigator, Affiliation: Hospital Gustavo Fricke, Viña del Mar, Chile
Jose I Vargas, MD, Principal Investigator, Affiliation: Escuela de Medicina, Universidad de Valparaíso, Chile
Daniela Jensen, MD, Principal Investigator, Affiliation: Escuela de Medicina, Universidad de Valparaíso
Felipe T Martinez, MD, Principal Investigator, Affiliation: Centro de Investigaciones Biomédicas, Escuela de Medicina, Universidad de Valparaíso

Overall contact:
Jose I Vargas, MD, Phone: 62473415, Ext: +56 9, Email: jivargasd@icloud.com

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Serologic Response

Secondary outcome:

Local Reactions to Vaccine

Systemic Reactions to the Vaccine

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Jose I Vargas, MD, Phone: 62473415, Ext: +56 9, Email: jivargasd@icloud.com

Hospital Gustavo Fricke, Viña del Mar, Valparaíso, Chile; Recruiting
Jose I Vargas, MD, Phone: 62473415, Ext: +56 9, Email: jivargasd@icloud.com
Daniela Jensen, MD, Phone: 62473409, Ext: +56 9, Email: daniela_jensen@hotmail.com
Jose I Vargas, MD, Principal Investigator
Daniela Jensen, MD, Principal Investigator
Francisco Fuster, MD, Principal Investigator
Valeska Sarmiento, Principal Investigator

Starting date: May 2015
Last updated: May 19, 2015