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:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hôpital Saint-Louis
Paris, France, 75010
Service des Maladies Infectieuses et Tropicales, Hopital Tenon
Paris, France, 75020
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Influenza, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014