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)
This study has been completed.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT01008813
First received: November 5, 2009
Last updated: December 21, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: adjuvanted A(H1N1)v influenza vaccine Biological: non-adjuvanted A(H1N1)v influenza vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:
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. [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the safety (local and general adverse events) between the two study vaccines [ Time Frame: From week 0 to week 48 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To compare the sustainability of the immune response induced by two injections of the study [ Time Frame: Day 21 and Day 42 ] [ Designated as safety issue: No ]
- To explore the post-vaccinal cellular immune response of the two study vaccines [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To assess vaccination failures and describe the clinical presentation of influenza in the study population [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
| Enrollment: | 306 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: adjuvanted A(H1N1)v influenza vaccine
Two injections at day 0 and day 21
|
Biological: 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
Other Name: Pandemrix
|
|
Experimental: non-adjuvanted A(H1N1)v influenza vaccine
Two injection at day 0 and day 21
|
Biological: 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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008813
Locations
| France | |
| Hôpital Henri Mondor | |
| Créteil, France, 94010 | |
| Hopital du Kremlin Bicêtre Service de médecine interne | |
| Kremlin Bicëtre, France, 94275 | |
| CIC de Vaccinologie Cochin Pasteur, hôpital Cochin | |
| Paris, France, 75679 | |
| Service des Maladies Infectieuses et Tropicales, Hopital Tenon | |
| Paris, France, 75020 | |
| Hôpital Saint-Louis | |
| Paris, France, 75010 | |
| Hôpital Gustave Dron, Service Maladies Infectieuses | |
| Tourcoing, France, 59208 | |
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
GlaxoSmithKline
Investigators
| Principal Investigator: | Odile Launay, MD | Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France |
More Information
Additional Information:
No publications provided
| Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT01008813 History of Changes |
| Other Study ID Numbers: | 2009-016226-13 |
| Study First Received: | November 5, 2009 |
| Last Updated: | December 21, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
HIV infection adjuvanted and non-adjuvanted A(H1N1)v influenza vaccine immunogenicity safety |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Influenza, Human Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Orthomyxoviridae Infections Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013