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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)
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)

NCT01008813

CompletedPhase 2

Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Conditions: HIV Infections

Interventions: adjuvanted A(H1N1)v influenza vaccine, non-adjuvanted A(H1N1)v influenza vaccine

Countries: France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (6)
  • Créteil, France
  • Kremlin Bicëtre, France
  • Paris, France
  • Paris, France
  • Paris, France
  • Tourcoing, France