HIV InfectionsPhase 2NCT01008813
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 Phase 2 study testing adjuvanted A(H1N1)v influenza vaccine and non-adjuvanted A(H1N1)v influenza vaccine in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 6 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- adjuvanted A(H1N1)v influenza vaccine and non-adjuvanted A(H1N1)v influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 6 sitesFrance
- Study dates
- Oct 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hôpital Henri Mondor
Créteil, 94010
Hopital du Kremlin Bicêtre Service de médecine interne
Kremlin Bicëtre, 94275
Hôpital Saint-Louis
Paris, 75010
Service des Maladies Infectieuses et Tropicales, Hopital Tenon
Paris, 75020
CIC de Vaccinologie Cochin Pasteur, hôpital Cochin
Paris, 75679
Hôpital Gustave Dron, Service Maladies Infectieuses
Tourcoing, 59208
About this study
Official 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)
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.
- Conditions
- HIV Infections
- Being tested
- adjuvanted A(H1N1)v influenza vaccine, non-adjuvanted A(H1N1)v influenza vaccine
- Keywords
- HIV infection, adjuvanted and non-adjuvanted A(H1N1)v influenza vaccine, immunogenicity, safety
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvanted A(H1N1)v influenza vaccineBiological
Also called Pandemrix
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
non-adjuvanted A(H1N1)v influenza vaccineBiological
Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 [A/California/7/2009 (H1N1)v] (15 microgram)
| Study group | Role | What they receive |
|---|---|---|
| adjuvanted A(H1N1)v influenza vaccine | Experimental | Two injections at day 0 and day 21 Receives: Biological: adjuvanted A(H1N1)v influenza vaccine |
| non-adjuvanted A(H1N1)v influenza vaccine | Experimental | Two injection at day 0 and day 21 Receives: Biological: non-adjuvanted A(H1N1)v influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 42
Secondary outcomes (7)
To evaluate the safety (local and general adverse events) between the two study vaccines
Measured: From week 0 to week 48
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
Measured: Day 21 and Day 42
To describe the factors influencing the response to the vaccine (such as age, sex, tobacco use, HAART, CD4 count and nadir, HIV viral load, ...)
Measured: From week 0 to week 48
To compare the sustainability of the immune response induced by two injections of the study
Measured: Day 21 and Day 42
To explore the post-vaccinal cellular immune response of the two study vaccines
Measured: Day 42
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)
Measured: Week 48
To assess vaccination failures and describe the clinical presentation of influenza in the study population
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Odile Launay, MD, Principal investigator, Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008813
- Sponsor's protocol ID
- ANRS 151 Hifluvac
- Other IDs
- 2009-016226-13, 2009
- Status last verified
- Dec 2011
- First submitted
- 5 Nov 2009
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01008813
- Acronym / sponsor ID
- ANRS 151 Hifluvac
- Conditions
- HIV Infections
- Keywords
- HIV infection, adjuvanted and non-adjuvanted A(H1N1)v influenza vaccine, immunogenicity, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- GlaxoSmithKline
- Study start
- Oct 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adjuvanted A(H1N1)v influenza vaccine | Experimental | Biological: adjuvanted A(H1N1)v influenza vaccineTwo injections at day 0 and day 21 |
| non-adjuvanted A(H1N1)v influenza vaccine | Experimental | Biological: non-adjuvanted A(H1N1)v influenza vaccineTwo injection at day 0 and day 21 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adjuvanted A(H1N1)v influenza vaccineAlso: PandemrixTwo 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 | Biological | adjuvanted A(H1N1)v influenza vaccine |
| non-adjuvanted A(H1N1)v influenza vaccineTwo intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 [A/California/7/2009 (H1N1)v] (15 microgram) | Biological | non-adjuvanted A(H1N1)v influenza vaccine |
Primary outcome
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
7 secondary outcomes
To evaluate the safety (local and general adverse events) between the two study vaccines
Time frame: From week 0 to week 48
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
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
To compare the sustainability of the immune response induced by two injections of the study
Time frame: Day 21 and Day 42
To explore the post-vaccinal cellular immune response of the two study vaccines
Time frame: Day 42
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
To assess vaccination failures and describe the clinical presentation of influenza in the study population
Time frame: Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- legal sponsor's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile Launay, MD principal investigator
Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adjuvanted A(H1N1)v influenza vaccine and non-adjuvanted A(H1N1)v influenza vaccine in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.