Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients

NCT00190242 | Completed Phase 3

• 1 other identifier: P050706
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.

Conditions

HIV Infection

Keywords

HIV; hepatitis A; vaccine; HBV and/or HCV co-infection

Outcome Measures

Primary Outcomes (1)

• percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination

  percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination

  during de study

Secondary Outcomes (4)

• anti-HAV antibodies mean geometric titers 7 months after the first vaccination

  during the study

• durability of seroprotection 1 year after the end of vaccination

  during the study

• safety

  during the study

• predictive factors of vaccinal response

  during the study

Study Arms (2)

group1:3 administrations of Havrix

EXPERIMENTAL

group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24

Drug: group1

group2: 2 administrations of Havrix

ACTIVE COMPARATOR

group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24

Drug: group2

Interventions

group1 DRUG

Havrix at 1440IU was administrated à weeks S0, S4 and S24

group1:3 administrations of Havrix

group2 DRUG

Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS

group2: 2 administrations of Havrix

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• VIH-1 infection, aged 18-55 years negative anti-HAV IgG CD4 cell count between 200 and 500/mm3

You may not qualify if:

• prior anti-HAV vaccination immunosuppressive treatment splenectomy Prothrombin time \< 50%, platelets\< 50 000/mm3 fever serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity \> 2 ULN for non co-infected patients, \> 5 ULN for co-infected patients

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ensemble contre le SIDA: collaborator
• GlaxoSmithKline: collaborator

Study Sites (2)

CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin

Paris, 75014, France

Location

CISIH, Hôpital de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

HIV Infections; Hepatitis A

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; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Odile Launay, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Sophie GRABAR, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: June 1, 2003
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2009
• Last Updated: December 16, 2011

Record last verified: 2005-06

Locations

FR (2)