Clinical Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT01008813
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief Summary

A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with or without adjuvant, in HIV-infected patients after one or two injections.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Primary Completion: 2010-02
• Study Completion: 2010-12
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• Age ≥ 18 years
• Able to give written consent
• Covered by French Social Security
• HIV-infected (infection attested by the patient's chart)
• Patients treated by HAART for at least 6 months, with a viral load inferior to 50 copies/mL on at least 2 last visits
• Patients without any treatment for HIV for at least 6 months and without any indication to start a treatment in the following 3 months
• Patients followed for their HIV-infection in an ANRS center and whose home is close to the center in case of influenza-like illness, consultation and hospitalization in the center where he is followed if necessary
• For women with childbearing potential, using an effective method of contraception, and willing to undergo urine pregnancy tests prior to each vaccination.

Exclusion Criteria

• Pregnancy
• Receipt of chemotherapy, immunotherapy (IL2, IL7, IV Ig), or corticosteroids within 3 months prior to enrolment
• Thrombopenia inferior to 20 000/mm3
• Febrile episode (at least 38°C rectal or if at least 37,5°C measured orally) within one week prior to vaccination
• Opportunistic infection (treated for less than 1 month)
• Co-infection with HCV and treated with IFNa
• Influenza (clinically or virologically documented) in the last 6 months
• History of documented auto-immune disease (lupus, systemic inflammatory disease, ...)
• Child C cirrhosis
• Solid organ transplant recipient
• Intolerance to 1 component of the vaccine
• Other immunization received within 3 weeks prior to inclusion or planned until after the last vaccine injection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity and safety of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients after two injections.	Day 42

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety (local and general adverse events) between the two study vaccines	From week 0 to week 48
To evaluate the immunogenicity of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients receiving antiretroviral therapy or not	Day 21 and Day 42
To describe the factors influencing the response to the vaccine (such as age, sex, tobacco use, HAART, CD4 count and nadir, HIV viral load, ...)	From week 0 to week 48
To compare the sustainability of the immune response induced by two injections of the study	Day 21 and Day 42
To explore the post-vaccinal cellular immune response of the two study vaccines	Day 42
To compare the consequences of the A(H1N1)v influenza vaccine, with or without adjuvant, on the HIV infection parameters (CD4 count, HIV viral load)	Week 48
To assess vaccination failures and describe the clinical presentation of influenza in the study population	Week 48

Trial Locations

Locations (6)

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Hopital du Kremlin Bicêtre Service de médecine interne; 🇫🇷 Kremlin Bicëtre, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

Service des Maladies Infectieuses et Tropicales, Hopital Tenon; 🇫🇷 Paris, France

CIC de Vaccinologie Cochin Pasteur, hôpital Cochin; 🇫🇷 Paris, France

Hôpital Gustave Dron, Service Maladies Infectieuses; 🇫🇷 Tourcoing, France