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

HIV Clinical Trial

— CORE-HIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003703
• Other study ID #: 45/2012
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Universidad de Valparaiso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• HIV
• Virus Diseases

Intervention

Biological:
• Recombinant Hepatitis B Virus Vaccine

Locations

Country	Name	City	State
Chile	Hospital Gustavo Fricke	Viña del Mar	Valparaíso

Sponsors (4)

Lead Sponsor	Collaborator
Universidad de Valparaiso	Aclin Laboratory, GlaxoSmithKline, Roche Pharma AG

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Local Reactions to Vaccine	Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure.	One Week after Exposure
Secondary	Systemic Reactions to the Vaccine	Number of participants presenting any systemic adverse reaction attributable to vaccination.	One Week after Exposure