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)

December 21, 2011 updated by: French National Agency for Research on AIDS and Viral Hepatitis

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Kremlin Bicëtre, France, 94275
        • Hopital du Kremlin Bicêtre Service de médecine interne
      • Paris, France, 75010
        • Hopital Saint-Louis
      • Paris, France, 75020
        • Service des Maladies Infectieuses et Tropicales, Hopital Tenon
      • Paris, France, 75679
        • CIC de Vaccinologie Cochin Pasteur, hôpital Cochin
      • Tourcoing, France, 59208
        • Hôpital Gustave Dron, Service Maladies Infectieuses

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety (local and general adverse events) between the two study vaccines
Time Frame: From week 0 to week 48
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
Time Frame: Day 21 and Day 42
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, ...)
Time Frame: From week 0 to week 48
From week 0 to week 48
To compare the sustainability of the immune response induced by two injections of the study
Time Frame: Day 21 and Day 42
Day 21 and Day 42
To explore the post-vaccinal cellular immune response of the two study vaccines
Time Frame: Day 42
Day 42
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
Week 48
To assess vaccination failures and describe the clinical presentation of influenza in the study population
Time Frame: Week 48
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Odile Launay, MD, Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimate)

November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

December 22, 2011

Last Update Submitted That Met QC Criteria

December 21, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-016226-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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