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

NCT02003703 | Completed Phase 3

• 1 other identifier: 45/2012
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B; HIV

Keywords

Vaccine; Primary Prevention; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Local Reactions to Vaccine

  One Week after Exposure

• Systemic Reactions to the Vaccine

  One Week after Exposure

Study Arms (2)

Recombinant Hepatitis B Virus Vaccine (High Dose)

EXPERIMENTAL

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.

Biological: Recombinant Hepatitis B Virus Vaccine

Recombinant Hepatitis B Virus Vaccine (Standard Dose)

ACTIVE COMPARATOR

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.

Biological: Recombinant Hepatitis B Virus Vaccine

Interventions

Recombinant Hepatitis B Virus Vaccine BIOLOGICAL

Also known as: Engerix B (GlaxoSmithKline)

Recombinant Hepatitis B Virus Vaccine (High Dose); Recombinant Hepatitis B Virus Vaccine (Standard Dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Proven Hepatitis B virus infection (acute or chronic).
• Proven hypersensitivity to the vaccine or any of its components.

Sponsors & Collaborators

• Universidad de Valparaiso: lead
• Roche Pharma AG: collaborator
• GlaxoSmithKline: collaborator
• Aclin Laboratory: collaborator

Study Sites (1)

Hospital Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

Location

Related Publications (1)

• 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.

  PMID: 34424307 DERIVED

MeSH Terms

Conditions

Hepatitis B

Interventions

Engerix-B; halofantrine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: May 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CL (1)