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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02323308

Acronym

ANRSHBEP03

Enrollment

Registered

2014-12-23

Start date

2010-12-31

Completion date

2014-06-30

Last updated

2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, HIV Infection

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.

Interventions

OTHERblood sampling

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Evaluation of immunological, virological and serological characteristics associated to anti-HBc isolated profile	at Day 0, inclusion visite
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

Secondary

Measure	Time frame
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 IgG+ memory B cells specific for HBcAg or HBs Ag	at baseline and 28 weeks after the first dose HBV vaccin
- Detection of HBV preS2 and S-specific T cells	at day 0 and week 28

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026