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

Primary Purpose

Hepatitis B, HIV

Status
Completed
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
Recombinant Hepatitis B Virus Vaccine
Sponsored by
Universidad de Valparaiso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Vaccine, Primary Prevention, Immunogenicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Gustavo Fricke

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recombinant Hepatitis B Virus Vaccine (High Dose)

Recombinant Hepatitis B Virus Vaccine (Standard Dose)

Arm Description

Patients allocated to this arm will receive three doses of 40mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.

Patients allocated to this arm will receive three doses of 20mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Local Reactions to Vaccine
Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure.
Systemic Reactions to the Vaccine
Number of participants presenting any systemic adverse reaction attributable to vaccination.

Full Information

First Posted
December 2, 2013
Last Updated
January 29, 2019
Sponsor
Universidad de Valparaiso
Collaborators
Roche Pharma AG, GlaxoSmithKline, Aclin Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT02003703
Brief Title
Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Valparaiso
Collaborators
Roche Pharma AG, GlaxoSmithKline, Aclin Laboratory

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, HIV
Keywords
Vaccine, Primary Prevention, Immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recombinant Hepatitis B Virus Vaccine (High Dose)
Arm Type
Experimental
Arm Description
Patients allocated to this arm will receive three doses of 40mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.
Arm Title
Recombinant Hepatitis B Virus Vaccine (Standard Dose)
Arm Type
Active Comparator
Arm Description
Patients allocated to this arm will receive three doses of 20mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months.
Intervention Type
Biological
Intervention Name(s)
Recombinant Hepatitis B Virus Vaccine
Other Intervention Name(s)
Engerix B (GlaxoSmithKline)
Primary Outcome Measure Information:
Title
Serologic Response
Description
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 Outcome Measure Information:
Title
Local Reactions to Vaccine
Description
Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure.
Time Frame
One Week after Exposure
Title
Systemic Reactions to the Vaccine
Description
Number of participants presenting any systemic adverse reaction attributable to vaccination.
Time Frame
One Week after Exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Fuster, MD
Organizational Affiliation
Hospital Gustavo Fricke, Viña del Mar, Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose I Vargas, MD
Organizational Affiliation
Escuela de Medicina, Universidad de Valparaíso, Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniela Jensen, MD
Organizational Affiliation
Escuela de Medicina, Universidad de Valparaíso
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felipe T Martinez, MD
Organizational Affiliation
Centro de Investigaciones Biomédicas, Escuela de Medicina, Universidad de Valparaíso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Gustavo Fricke
City
Viña del Mar
State/Province
Valparaíso
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
34424307
Citation
Vargas JI, Jensen D, Martinez F, Sarmiento V, Peirano F, Acuna P, Provoste F, Bustos V, Cornejo F, Fuster A, Acuna M, Fuster F, Soto S, Estay D, Jensen W, Ahumada R, Arab JP, Soza A, Fuster F. Comparative Efficacy of a High-Dose vs Standard-Dose Hepatitis B Revaccination Schedule Among Patients With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2120929. doi: 10.1001/jamanetworkopen.2021.20929.
Results Reference
derived

Learn more about this trial

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

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