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)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Phase II 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)

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: adjuvanted A(H1N1)v influenza vaccine
* Biological: non-adjuvanted A(H1N1)v influenza vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adjuvanted A(H1N1)v influenza vaccine<br>Two injections at day 0 and day 21 | Biological: adjuvanted A(H1N1)v influenza vaccine<br>* 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<br>* Other names: Pandemrix;|
| Experimental: non-adjuvanted A(H1N1)v influenza vaccine<br>Two injection at day 0 and day 21 | Biological: non-adjuvanted A(H1N1)v influenza vaccine<br>* Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 [A/California/7/2009 (H1N1)v] (15 microgram)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infection, adjuvanted and non-adjuvanted A(H1N1)v influenza vaccine, immunogenicity, safety