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

Completed

• Conditions: Hepatitis B; HIV Infection
• Interventions: Other: blood sampling

• Registration Number: NCT02323308
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-07-11
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-22
• Last Update Submitted: 2014-12-22
• Study First Posted: 2014-12-23
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vaccination	blood sampling	Anti-HBV vaccine injection

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Detection of IgG+ memory B cells specific for HBcAg or HBs Ag	at baseline and 28 weeks after the first dose HBV vaccin
Number of patients with HBsAb titers as protective titer>10 IU/L	at 4 weeks,28 weeks and 18 month after the first dose HBV vaccin
- Detection of HBV preS2 and S-specific T cells	at day 0 and week 28

Trial Locations

Locations (1)

Chu Dijon; 🇫🇷 Dijon, France