CompletedPhase 2

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)

France306 participantsStarted 2009-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT01008813

SponsorFrench National Agency for Research on AIDS and Viral Hepatitis

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2010-02

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