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

NCT ID: NCT02003703

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Recombinant Hepatitis B Virus Vaccine

Intervention Type: BIOLOGICAL

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.

Group Type: ACTIVE_COMPARATOR

Recombinant Hepatitis B Virus Vaccine

Intervention Type: BIOLOGICAL

Interventions

Recombinant Hepatitis B Virus Vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

Engerix B (GlaxoSmithKline)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Aclin Laboratory

OTHER

Sponsor Role: collaborator

Universidad de Valparaiso

OTHER

Sponsor Role: lead

Responsible Party

Felipe Martinez

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco Fuster, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Gustavo Fricke, Viña del Mar, Chile

Jose I Vargas, MD

Role: PRINCIPAL_INVESTIGATOR

Escuela de Medicina, Universidad de Valparaíso, Chile

Daniela Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Escuela de Medicina, Universidad de Valparaíso

Felipe T Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Investigaciones Biomédicas, Escuela de Medicina, Universidad de Valparaíso

Locations

Hospital Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

Countries

Chile

References

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.

Reference Type: DERIVED

PMID: 34424307 (View on PubMed)

Other Identifiers

45/2012

Identifier Type: -

Identifier Source: org_study_id