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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
306
Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 \[A/California/7/2009 (H1N1)v\] (3,8 microgram) adjuvanted with AS 03A
Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 \[A/California/7/2009 (H1N1)v\] (15 microgram)
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
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.
Time frame: Day 42
To evaluate the safety (local and general adverse events) between the two study vaccines
Time frame: 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
Time frame: 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, ...)
Time frame: From week 0 to week 48
To compare the sustainability of the immune response induced by two injections of the study
Time frame: Day 21 and Day 42
To explore the post-vaccinal cellular immune response of the two study vaccines
Time frame: 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)
Time frame: Week 48
To assess vaccination failures and describe the clinical presentation of influenza in the study population
Time frame: Week 48
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