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)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
adjuvanted A(H1N1)v influenza vaccine
non-adjuvanted A(H1N1)v influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV infection, adjuvanted and non-adjuvanted A(H1N1)v influenza vaccine, immunogenicity, safety
Eligibility Criteria
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.
Sites / Locations
- Hôpital Henri Mondor
- Hopital du Kremlin Bicêtre Service de médecine interne
- Hôpital Saint-Louis
- Service des Maladies Infectieuses et Tropicales, Hopital Tenon
- CIC de Vaccinologie Cochin Pasteur, hôpital Cochin
- Hôpital Gustave Dron, Service Maladies Infectieuses
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
adjuvanted A(H1N1)v influenza vaccine
non-adjuvanted A(H1N1)v influenza vaccine
Arm Description
Two injections at day 0 and day 21
Two injection at day 0 and day 21
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To evaluate the safety (local and general adverse events) between the two study vaccines
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
To describe the factors influencing the response to the vaccine (such as age, sex, tobacco use, HAART, CD4 count and nadir, HIV viral load, ...)
To compare the sustainability of the immune response induced by two injections of the study
To explore the post-vaccinal cellular immune response of the two study vaccines
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)
To assess vaccination failures and describe the clinical presentation of influenza in the study population
Full Information
NCT ID
NCT01008813
First Posted
November 5, 2009
Last Updated
December 21, 2011
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01008813
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV infection, adjuvanted and non-adjuvanted A(H1N1)v influenza vaccine, immunogenicity, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
adjuvanted A(H1N1)v influenza vaccine
Arm Type
Experimental
Arm Description
Two injections at day 0 and day 21
Arm Title
non-adjuvanted A(H1N1)v influenza vaccine
Arm Type
Experimental
Arm Description
Two injection at day 0 and day 21
Intervention Type
Biological
Intervention Name(s)
adjuvanted A(H1N1)v influenza vaccine
Other Intervention Name(s)
Pandemrix
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
non-adjuvanted A(H1N1)v influenza vaccine
Intervention Description
Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 [A/California/7/2009 (H1N1)v] (15 microgram)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the safety (local and general adverse events) between the two study vaccines
Time Frame
From week 0 to week 48
Title
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
Title
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
Title
To compare the sustainability of the immune response induced by two injections of the study
Time Frame
Day 21 and Day 42
Title
To explore the post-vaccinal cellular immune response of the two study vaccines
Time Frame
Day 42
Title
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
Title
To assess vaccination failures and describe the clinical presentation of influenza in the study population
Time Frame
Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odile Launay, MD
Organizational Affiliation
Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital du Kremlin Bicêtre Service de médecine interne
City
Kremlin Bicëtre
ZIP/Postal Code
94275
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Service des Maladies Infectieuses et Tropicales, Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
CIC de Vaccinologie Cochin Pasteur, hôpital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Hôpital Gustave Dron, Service Maladies Infectieuses
City
Tourcoing
ZIP/Postal Code
59208
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.anrs.fr
Description
legal sponsor's website
Learn more about this trial
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)
We'll reach out to this number within 24 hrs