Isolated Anti-HBc Serological Profile in HIV Infected Patients: Immunological, Virological Characteristics and Response to Hepatitis B Vaccination (ANRSHBEP03)

December 22, 2014 updated by: ANRS, Emerging Infectious Diseases

Study of Immunological, Virological, Serological Characteristics of HIV+ Patients Harboring Isolated Anti-HBc Profile 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France
        • CHU Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with HIV infection and presenting with "isolated anti-HBc" profile. HBV vaccination is recommended fot these patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
vaccination
Anti-HBV vaccine injection
Other: blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of immunological, virological and serological characteristics associated to "anti-HBc isolated" profile
Time Frame: at Day 0, inclusion visite
at Day 0, inclusion visite
Average titers of anti-HBs Ab
Time Frame: at 4 weeks, 28 weeks and 18 months after the first vaccination HBV
at 4 weeks, 28 weeks and 18 months after the first vaccination HBV
Analysis of B-cell phenotype and maturation
Time Frame: at baseline and at week 28
at baseline and at week 28

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at 4 weeks,28 weeks and 18 month after the first dose HBV vaccin
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
at baseline and 28 weeks after the first dose HBV vaccin
- Detection of HBV preS2 and S-specific T cells
Time Frame: at day 0 and week 28
at day 0 and week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: Lionel Piroth, CHU Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS HB EP 03 CISOVAC
  • 2010-A00511-38 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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