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NCT Number: 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)

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Henri Mondor, Créteil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

adjuvanted A(H1N1)v influenza vaccine

Biological

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

Other names: Pandemrix

Non-adjuvanted A(H1N1)v influenza vaccine

Biological

Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 [A/California/7/2009 (H1N1)v] (15 microgram)

Primary outcomes

  1. 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.

    Time frame: Day 42

Secondary outcomes

  1. To evaluate the safety (local and general adverse events) between the two study vaccines

    Time frame: From week 0 to week 48

  2. 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

    Time frame: Day 21 and Day 42

  3. To describe the factors influencing the response to the vaccine (such as age, sex, tobacco use, HAART, CD4 count and nadir, HIV viral load, ...)

    Time frame: From week 0 to week 48

  4. To compare the sustainability of the immune response induced by two injections of the study

    Time frame: Day 21 and Day 42

  5. To explore the post-vaccinal cellular immune response of the two study vaccines

    Time frame: Day 42

  6. 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)

    Time frame: Week 48

  7. To assess vaccination failures and describe the clinical presentation of influenza in the study population

    Time frame: Week 48

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2009
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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