Clinical trial NCT01008813: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV infection
adjuvanted and non-adjuvanted A(H1N1)v influenza vaccine
immunogenicity
safety
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: GlaxoSmithKline
First posted: 2009-11-06
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Day 42
Secondary outcomes:
measure: To evaluate the safety (local and general adverse events) between the two study vaccines
timeFrame: From week 0 to week 48
measure: 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
timeFrame: Day 21 and Day 42
measure: To describe the factors influencing the response to the vaccine (such as age, sex, tobacco use, HAART, CD4 count and nadir, HIV viral load, ...)
timeFrame: From week 0 to week 48
measure: To compare the sustainability of the immune response induced by two injections of the study
timeFrame: Day 21 and Day 42
measure: To explore the post-vaccinal cellular immune response of the two study vaccines
timeFrame: Day 42
measure: 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)
timeFrame: Week 48
measure: To assess vaccination failures and describe the clinical presentation of influenza in the study population
timeFrame: Week 48
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Kremlin Bicëtre
country: France
facility: Hopital du Kremlin Bicêtre Service de médecine interne
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Service des Maladies Infectieuses et Tropicales, Hopital Tenon
city: Paris
country: France
facility: CIC de Vaccinologie Cochin Pasteur, hôpital Cochin
city: Tourcoing
country: France
facility: Hôpital Gustave Dron, Service Maladies Infectieuses
Study officials:
affiliation: Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France
name: Odile Launay, MD
role: PRINCIPAL_INVESTIGATOR
References: