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

Purpose

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.

Condition	Intervention	Phase
HIV Infection	Drug: group1 Drug: group2	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Study of Immunogenicity of Anti-HAV Immunisation in HIV-1 Infected Patients, Co-infected or Not With HBV and/or HCV. HEP.A.VAC Study.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
percentage of patients with anti-HAV antibodies superior 20 mUI/ml 7 months after the first vaccination

Secondary Outcome Measures:

anti-HAV antibodies mean geometric titers 7 months after the first vaccination [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
anti-HAV antibodies mean geometric titers 7 months after the first vaccination
durability of seroprotection 1 year after the end of vaccination [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
durability of seroprotection 1 year after the end of vaccination
safety [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
safety
predictive factors of vaccinal response [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
predictive factors of vaccinal response


Enrollment:	99
Study Start Date:	June 2003
Study Completion Date:	October 2009
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: group1:3 administrations of Havrix group 1 received immunisation with Havrix (1440IU) at weeks S0, S4, S24	Drug: group1 Havrix at 1440IU was administrated à weeks S0, S4 and S24
Active Comparator: group2: 2 administrations of Havrix group 2 received usual immunisation with Havrix (1440IU) at weeks S0 and S24	Drug: group2 Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS

Detailed Description:

RECOMMANDATIONS for hepatitis A vaccination is the same for HIV-infected patients than for general population. However, immunogenicity induced with 2 doses of anti-HAV vaccine is lower in HIV-infected patients. The primary objective of the study is to compare the immunogenicity (percentage of patients with anti-HAV antibodies > 20 mUI/ml at month 7) of 2 strategies (2 doses at months 1 and 6, versus 3 doses at months 1, 2 and 6)of anti-HAV vaccine in HIV-1 infected patients co-infected with HBV and/or HCV with CD4 cell count between 200 and 500/mm3. The second objectives are to compare mean anti-HAV antibodies titers obtained with the 2 strategies, the durability of the seroprotection 12 months after the end of vaccination, and the safety. The PARAMATERS than may have an effect on the immune response will be evaluated.

This open, prospective, study have included 99 patients, aged from 18 to 55 years old. Patients were randomized to receive 2 or 3 doses of HAVRIX 1440 UI intramuscularly at week O, 4, and 24 or week 0, and 24. Clinical and biological safety is evaluated after each immunisation and blood samples for serological evaluation taken at week -4, 4, 8, 24 and 28 for immunogenicity and week 72 for long term analysis

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190242

Locations


France
CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin
Paris, France, 75014
CISIH, Hôpital de Strasbourg
Strasbourg, France, 67091

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Ensemble contre le SIDA

GlaxoSmithKline

Investigators


Principal Investigator:	Odile Launay, MD	Assistance Publique - Hôpitaux de Paris
Study Chair:	Sophie GRABAR, MD	Assistance Publique - Hôpitaux de Paris

More Information


Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00190242 History of Changes
Other Study ID Numbers:	P050706
Study First Received:	September 13, 2005
Last Updated:	December 15, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:


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

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Immunologic Deficiency Syndromes Immune System Diseases Vaccines Hepatitis A Antibodies Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016

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