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HIV patients get safer flu shot options in new vaccine trial

NCT ID NCT01008813

Disease control Sponsor: French National Agency for Research on AIDS and Viral Hepatitis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two versions of the H1N1 flu vaccine in 306 people living with HIV. One vaccine included an adjuvant (a booster ingredient) and the other did not. The goal was to see which vaccine was safer and better at protecting against the flu. Participants were followed for one year after receiving one or two shots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

306 people

The number who actually took part.

Start date

Oct 2009

Finished

Dec 2010

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • CIC de Vaccinologie Cochin Pasteur, hôpital Cochin

    Paris, 75679, France

  • Hopital du Kremlin Bicêtre Service de médecine interne

    Kremlin Bicëtre, 94275, France

  • Hôpital Gustave Dron, Service Maladies Infectieuses

    Tourcoing, 59208, France

  • Hôpital Henri Mondor

    Créteil, 94010, France

  • Hôpital Saint-Louis

    Paris, 75010, France

  • Service des Maladies Infectieuses et Tropicales, Hopital Tenon

    Paris, 75020, France

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