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 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)
1 other identifier
interventional
306
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Oct 2009
Shorter than P25 for phase_2 hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 22, 2011
December 1, 2011
4 months
November 5, 2009
December 21, 2011
Conditions
Keywords
Outcome Measures
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.
Day 42
Secondary Outcomes (7)
To evaluate the safety (local and general adverse events) between the two study vaccines
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
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, ...)
From week 0 to week 48
To compare the sustainability of the immune response induced by two injections of the study
Day 21 and Day 42
To explore the post-vaccinal cellular immune response of the two study vaccines
Day 42
- +2 more secondary outcomes
Study Arms (2)
adjuvanted A(H1N1)v influenza vaccine
EXPERIMENTALTwo injections at day 0 and day 21
non-adjuvanted A(H1N1)v influenza vaccine
EXPERIMENTALTwo injection at day 0 and day 21
Interventions
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
Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 \[A/California/7/2009 (H1N1)v\] (15 microgram)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hôpital Henri Mondor
Créteil, 94010, France
Hopital du Kremlin Bicêtre Service de médecine interne
Kremlin Bicëtre, 94275, France
Hôpital Saint-Louis
Paris, 75010, France
Service des Maladies Infectieuses et Tropicales, Hopital Tenon
Paris, 75020, France
CIC de Vaccinologie Cochin Pasteur, hôpital Cochin
Paris, 75679, France
Hôpital Gustave Dron, Service Maladies Infectieuses
Tourcoing, 59208, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Odile Launay, MD
Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
October 1, 2009
Primary Completion
February 1, 2010
Study Completion
December 1, 2010
Last Updated
December 22, 2011
Record last verified: 2011-12