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Trial record 18 of 28 for:    pandemrix

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)

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ClinicalTrials.gov Identifier: NCT01008813
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : December 22, 2011
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 6, 2009
Last Update Posted Date December 22, 2011
Study Start Date  ICMJE October 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01008813 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
  • To evaluate the safety (local and general adverse events) between the two study vaccines [ Time Frame: 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 ]
  • 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 ]
  • To compare the sustainability of the immune response induced by two injections of the study [ Time Frame: Day 21 and Day 42 ]
  • To explore the post-vaccinal cellular immune response of the two study vaccines [ Time Frame: 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 ]
  • To assess vaccination failures and describe the clinical presentation of influenza in the study population [ Time Frame: Week 48 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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
  • 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)
Study Arms  ICMJE
  • Experimental: adjuvanted A(H1N1)v influenza vaccine
    Two injections at day 0 and day 21
    Intervention: Biological: adjuvanted A(H1N1)v influenza vaccine
  • Experimental: non-adjuvanted A(H1N1)v influenza vaccine
    Two injection at day 0 and day 21
    Intervention: Biological: non-adjuvanted A(H1N1)v influenza vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2011)
306
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2009)
300
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01008813
Other Study ID Numbers  ICMJE 2009-016226-13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party French National Agency for Research on AIDS and Viral Hepatitis
Study Sponsor  ICMJE French National Agency for Research on AIDS and Viral Hepatitis
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Odile Launay, MD Centre d'investigation clinique de vaccinologie Cochin-Pasteur, Hôpital Cochin, Paris, France
PRS Account French National Agency for Research on AIDS and Viral Hepatitis
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP