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Completed

NCT Number: NCT02003703

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Gustavo Fricke

Viña del Mar, Valparaiso, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recombinant Hepatitis B Virus Vaccine

Biological

Other names: Engerix B (GlaxoSmithKline)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Systemic Reactions to the Vaccine

    Time frame: One Week after Exposure

    Number of participants presenting any systemic adverse reaction attributable to vaccination.

Sponsors and collaborators

Lead sponsor

Universidad de Valparaiso

Other

Collaborators

  • Aclin Laboratory
  • GlaxoSmithKline
  • Roche Pharma AG

Registry information

Official study title

Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV : A Randomised Trial

Acronym: CORE-HIV

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2013
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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