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

ANRS, Emerging Infectious Diseases1 site in 1 country55 target enrollmentDecember 2010

ConditionsHIV Infection Hepatitis B

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV Infection
Sponsor: ANRS, Emerging Infectious Diseases
Enrollment: 55
Locations: 1
Primary Endpoint: Average titers of anti-HBs Ab
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

June 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

ANRS, Emerging Infectious Diseases

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Average titers of anti-HBs Ab

Time Frame: 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

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

Time Frame: at Day 0, inclusion visite

Secondary Outcomes

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)