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

NCT02323308 | Completed DMC

• 2 other identifiers: ANRS HB EP 03 CISOVAC2010-A00511-38
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; Hepatitis B

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

vaccination

Anti-HBV vaccine injection

Other: blood sampling

Interventions

blood sampling OTHER

vaccination

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Chu Dijon

Dijon, France

Location

MeSH Terms

Conditions

HIV Infections; Hepatitis B

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lionel Piroth

  CHU DIJON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: December 23, 2014
• Study Start: December 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

FR (1)