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
- Interventions
- Biological: adjuvanted A(H1N1)v influenza vaccineBiological: non-adjuvanted A(H1N1)v influenza vaccine
- 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
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
- Arm && Interventions
Group Intervention Description adjuvanted A(H1N1)v influenza vaccine adjuvanted A(H1N1)v influenza vaccine Two injections at day 0 and day 21 non-adjuvanted A(H1N1)v influenza vaccine non-adjuvanted A(H1N1)v influenza vaccine Two injection at day 0 and day 21
- 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 Gustave Dron, Service Maladies Infectieuses
🇫🇷Tourcoing, France
Hôpital Saint-Louis
🇫🇷Paris, France
CIC de Vaccinologie Cochin Pasteur, hôpital Cochin
🇫🇷Paris, France
Hopital du Kremlin Bicêtre Service de médecine interne
🇫🇷Kremlin Bicëtre, France
Hôpital Henri Mondor
🇫🇷Créteil, France
Service des Maladies Infectieuses et Tropicales, Hopital Tenon
🇫🇷Paris, France