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

• ClinicalTrials.gov Identifier: NCT02003703
• Recruitment Status: Completed
• First Posted: December 6, 2013
• Last Update Posted: January 31, 2019
• Sponsor: Universidad de Valparaiso
• Collaborators: Roche Pharma AG; GlaxoSmithKline; Aclin Laboratory
• Information provided by (Responsible Party): Felipe Martinez, Universidad de Valparaiso

Tracking Information

• First Submitted Date: December 2, 2013
• First Posted Date: December 6, 2013
• Last Update Posted Date: January 31, 2019
• Study Start Date: May 2015
• Actual Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 5, 2013)

Serologic Response [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 5, 2013)

• Local Reactions to Vaccine [ Time Frame: One Week after Exposure ]
  Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure.
• Systemic Reactions to the Vaccine [ Time Frame: One Week after Exposure ]
  Number of participants presenting any systemic adverse reaction attributable to vaccination.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .
• Official Title: Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV : A Randomised Trial
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Hepatitis B
• HIV

Intervention

Biological: Recombinant Hepatitis B Virus Vaccine

Other Name: Engerix B (GlaxoSmithKline)

Study Arms

• Experimental: Recombinant Hepatitis B Virus Vaccine (High Dose)
  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.
  Intervention: Biological: Recombinant Hepatitis B Virus Vaccine
• Active Comparator: Recombinant Hepatitis B Virus Vaccine (Standard Dose)
  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: Biological: Recombinant Hepatitis B Virus Vaccine

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 29, 2019): 107
• Original Estimated Enrollment (submitted: December 5, 2013): 150
• Actual Study Completion Date: December 2018
• Actual Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Chile

Administrative Information

• NCT Number: NCT02003703
• Other Study ID Numbers: 45/2012
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Felipe Martinez, Universidad de Valparaiso
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad de Valparaiso
• Original Study Sponsor: Same as current

Collaborators

• Roche Pharma AG
• GlaxoSmithKline
• Aclin Laboratory

Investigators

• Principal Investigator: Francisco Fuster, MD; Hospital Gustavo Fricke, Viña del Mar, Chile
• Principal Investigator: Jose I Vargas, MD; Escuela de Medicina, Universidad de Valparaíso, Chile
• Principal Investigator: Daniela Jensen, MD; Escuela de Medicina, Universidad de Valparaíso
• Principal Investigator: Felipe T Martinez, MD; Centro de Investigaciones Biomédicas, Escuela de Medicina, Universidad de Valparaíso

• PRS Account: Universidad de Valparaiso
• Verification Date: January 2019