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)
NCT ID: NCT01008813
Last Updated: 2011-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
306 participants
INTERVENTIONAL
2009-10-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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adjuvanted A(H1N1)v influenza vaccine
Two injections at day 0 and day 21
adjuvanted A(H1N1)v influenza vaccine
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 vaccine
Two injection at day 0 and day 21
non-adjuvanted A(H1N1)v influenza vaccine
Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 \[A/California/7/2009 (H1N1)v\] (15 microgram)
Interventions
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adjuvanted A(H1N1)v influenza vaccine
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 vaccine
Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 \[A/California/7/2009 (H1N1)v\] (15 microgram)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
French National Agency for Research on AIDS and Viral Hepatitis
OTHER_GOV
Responsible Party
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Principal Investigators
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Odile Launay, MD
Role: PRINCIPAL_INVESTIGATOR
Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France
Locations
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Hôpital Henri Mondor
Créteil, , France
Hopital du Kremlin Bicêtre Service de médecine interne
Kremlin Bicëtre, , France
Hôpital Saint-Louis
Paris, , France
Service des Maladies Infectieuses et Tropicales, Hopital Tenon
Paris, , France
CIC de Vaccinologie Cochin Pasteur, hôpital Cochin
Paris, , France
Hôpital Gustave Dron, Service Maladies Infectieuses
Tourcoing, , France
Countries
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Related Links
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legal sponsor's website
Other Identifiers
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2009-016226-13
Identifier Type: -
Identifier Source: org_study_id