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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02003703

Acronym

CORE-HIV

Enrollment

107

Registered

2013-12-06

Start date

2015-05-31

Completion date

2018-12-31

Last updated

2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, HIV

Keywords

Vaccine, Primary Prevention, Immunogenicity

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.

Interventions

BIOLOGICALRecombinant Hepatitis B Virus Vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026