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OpenTrials
Completed

NCT Number: NCT02323308

Isolated Anti-HBc Serological Profile in HIV Infected Patients: Immunological, Virological Characteristics and Response to Hepatitis B Vaccination

The aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to assess the response to vaccination in these patients.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Genital Diseases HIV Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon

Dijon, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV+ adults patients
  • negative HBsAg
  • negative a-HBs Ab
  • positive HBc Ab
  • without HBV - vaccination
  • CD4 cell above 200 /mm3
  • HIV viral load below 50 copies/mL

Exclusion criteria

  • positive HBs antigenemia in the past
  • transaminitis above fivefold upper normal limit
  • PT<50% or Platelet <50 000/mm3
  • ongoing opportunistic infection
  • ongoing or recent systemic corticoid or immunomodulatory therapy, splenectomy, pregnancy, contra-indication to intramuscular injection, familial history of neurological disease.

Treatment and study plan

Blood sampling

Other

Primary outcomes

  1. Evaluation of immunological, virological and serological characteristics associated to "anti-HBc isolated" profile

    Time frame: at Day 0, inclusion visite

  2. Average titers of anti-HBs Ab

    Time frame: at 4 weeks, 28 weeks and 18 months after the first vaccination HBV

  3. Analysis of B-cell phenotype and maturation

    Time frame: at baseline and at week 28

Secondary outcomes

  1. Number of patients with HBsAb titers as protective titer>10 IU/L

    Time frame: at 4 weeks,28 weeks and 18 month after the first dose HBV vaccin

  2. Detection of IgG+ memory B cells specific for HBcAg or HBs Ag

    Time frame: at baseline and 28 weeks after the first dose HBV vaccin

  3. - Detection of HBV preS2 and S-specific T cells

    Time frame: at day 0 and week 28

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study title

Study of Immunological, Virological, Serological Characteristics of HIV+ Patients Harboring Isolated Anti-HBc Profile and Response to Hepatitis B Vaccination

Acronym: ANRSHBEP03

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2014
Registry last updated
Dec 23, 2014

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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