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)

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Biological: non-adjuvanted A(H1N1)v influenza vaccine

Biological: adjuvanted A(H1N1)v influenza vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01008813

2009-016226-13

Details and patient eligibility

About

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.

Enrollment

306 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.