Trial record 15 of 435 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Universidad de Valparaiso
Sponsor:
Collaborators:
Roche Pharma AG
GlaxoSmithKline
Aclin Laboratories, Chile
Information provided by (Responsible Party):
Felipe Martinez, Universidad de Valparaiso
ClinicalTrials.gov Identifier:
NCT02003703
First received: December 2, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Hepatitis B
HIV
Biological: Recombinant Hepatitis B Virus Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV : A Randomised Trial

Resource links provided by NLM:


Further study details as provided by Universidad de Valparaiso:

Primary Outcome Measures:
  • Serologic Response [ Time Frame: 4-8 weeks After Exposure ] [ Designated as safety issue: No ]
    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 [ Time Frame: One Week after Exposure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of participants presenting any systemic adverse reaction attributable to vaccination.


Estimated Enrollment: 150
Study Start Date: December 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Recombinant Hepatitis B Virus Vaccine
Other Name: Engerix B (GlaxoSmithKline)
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.
Biological: Recombinant Hepatitis B Virus Vaccine
Other Name: Engerix B (GlaxoSmithKline)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003703

Contacts
Contact: Jose I Vargas, MD 62473415 ext +56 9 jivargasd@icloud.com
Contact: Daniela Jensen, MD 62473409 ext +56 9 daniela_jensen@hotmail.com

Locations
Chile
Hospital Gustavo Fricke Not yet recruiting
Viña del Mar, Valparaíso, Chile
Contact: Jose I Vargas, MD    62473415 ext +56 9    jivargasd@icloud.com   
Contact: Daniela Jensen, MD    62473409 ext +56 9    daniela_jensen@hotmail.com   
Principal Investigator: Jose I Vargas, MD         
Principal Investigator: Daniela Jensen, MD         
Principal Investigator: Francisco Fuster, MD         
Principal Investigator: Valeska Sarmiento         
Sponsors and Collaborators
Universidad de Valparaiso
Roche Pharma AG
GlaxoSmithKline
Aclin Laboratories, Chile
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
  More Information

No publications provided

Responsible Party: Felipe Martinez, MD, Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT02003703     History of Changes
Other Study ID Numbers: 45/2012
Study First Received: December 2, 2013
Last Updated: December 5, 2013
Health Authority: Chile: Institutional Review Board

Keywords provided by Universidad de Valparaiso:
Vaccine
Primary Prevention
Immunogenicity

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Virus Diseases
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 22, 2014