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Trial record 19 of 33 for:    " February 09, 2011":" March 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient. (EP46 NOVAA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT01426243
First received: February 10, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

Main objective :

To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative individuals who had not been given YFV before.

Secondary objectives :

  • To develop and assess ELISPOT technology for yellow fever and to measure the response within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months) in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3) neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference method) and a new pseudotype based method, (4) post-vaccination viremia and (5) diversity of viral quasi-species.
  • To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and viral load.

Condition Intervention Phase
HIV Infection
Yellow Fever
Biological: Yellow fever vaccination (STAMARIL)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Immuno-virologic criterion [ Time Frame: DAY-7 ] [ Designated as safety issue: Yes ]
    - At Day-7 will be determined the levels of antibodies by fluorescence.

  • Immuno-virologic criterion [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
    At Day 0 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia

  • Immuno-virologic criterion [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
    At Day 28 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis (if it's positive at day7) and nucleotide sequences on phylogenetic strains of viremia

  • Immuno-virologic criterion [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
    At Month 3 will be determined fluorescence, PRNT and ELISPOT.

  • Immuno-virologic criterion [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
    At Month 12 will be determined fluorescence, PRNT and ELISPOT.

  • Immuno-virologic criterion [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    At Day 7 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia


Secondary Outcome Measures:
  • Clinical and biological tolerance [ Time Frame: day -7 ] [ Designated as safety issue: Yes ]
    At Day -7 will be determined the levels of antibodies by fluorescence

  • clinical and biological tolerance [ Time Frame: day 0 ] [ Designated as safety issue: Yes ]
    At Day 0: incidence of HIV+ event and general+local reactions of d°>2 after vaccination

  • clinical and biological tolerance [ Time Frame: day 7 ] [ Designated as safety issue: Yes ]
    At Day7: incidence of HIV+ event and general+local reactions of d°>2 after vaccination

  • clinical and biological tolerance [ Time Frame: day 14 ] [ Designated as safety issue: Yes ]
    At Day14:incidence of HIV+ event and general+local reactions of d°>2 after vaccination

  • clinical and biological tolerance [ Time Frame: day 28 ] [ Designated as safety issue: Yes ]
    At Day 28:incidence of HIV+ event and general+local reactions of d°>2 after vaccination

  • clinical and biological tolerance [ Time Frame: month 3 ] [ Designated as safety issue: Yes ]
    At Month3:incidence of HIV+ event and general+local reactions of d°>2 after vaccination

  • clinical and biological tolerance [ Time Frame: month 12 ] [ Designated as safety issue: Yes ]
    At Month 12:incidence of HIV+ event and general+local reactions of d°>2 after vaccination


Enrollment: 71
Study Start Date: July 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Voluntary HIV positive subjects
40 HIV positive adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment), > 350 CD4/mm3 (with half of them a nadir < 200 CD4/mm3) and a viral load < 50 copies/mL for at least 6 months. Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen.
Biological: Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL)
HIV negative subjects
Voluntary HIV negative subjects matched according to age (18-40 years and 40-55 years) and with HIV positive subjects, vaccinated at J0 and followed over one year
Biological: Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL)
Biological: Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL)

Detailed Description:

Method :

Clinical Trial Phase III, Multicentre protocol at Saint-Louis hospital, Bichat hospital and Cochin-Pasteur hospital, with CERVI, INSERM U 941 and SC10 collaboration.

Trial treatment : Yellow fever vaccination (STAMARIL)

Criterion :

Immuno-virologic: At J-7, J7, J28, M3 and M12 will be determined the levels of antibodies by fluorescence, at J0, J7, J28, M3 and M12 titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia. Titles and Amariles kinetics of viremia, neutralizing antibodies and ELISPOT will be considered as surrogate markers of response in terms of groups.

Clinical and biological tolerance: At all follows up will be measured the incidence of CDC classification events (for HIV+) and general and local reactions of degree ≥ 2 in the setting of the injection of STAMARIL®.

Schedule :

Date of first enrolment : third quarter 2011. Inclusion period : 18 months. For each subject, participation in this trial will be for 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Group 1: Voluntary HIV positive subjects

Inclusion Criteria:

  • Adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment)
  • > 350 CD4/mm3 (with half of them a nadir < 200 CD4/mm3) and a viral load < 50 copies/mL for at least 6 months.
  • Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen.

Exclusion Criteria:

  • Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive.
  • Administration of immunoglobulins < 3 months or any vaccine <1 month.
  • Pregnancy ongoing or planned during the study.
  • Coinfection with HCV virus untreated.
  • HBs Ag positive.
  • Hypersensitivity reaction to eggs / chicken protein; hereditary fructose intolerance.
  • Immunosuppression, whether congenital, idiopathic or as a result of corticosteroids systemically (at doses ≥ 20mg/d of prednisone), or due to radiation or antineoplastic older than 6 months.
  • History of thymic dysfunction (including thymoma and thymectomy).
  • For HIV + subjects: ART Celsentri or by other anti-CCR5.

Group 2: HIV negative subjects

Inclusion Criteria:

HIV and HCV negatives

Exclusion Criteria:

  • Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive.
  • Administration of immunoglobulins < 3 months or any vaccine <1 month.
  • Other vaccinations should be deferred beyond M3.
  • Pregnancy ongoing or planned during the study.
  • Coinfection with HCV virus untreated.
  • HBs Ag positive.
  • Hypersensitivity reaction to eggs / chicken protein; hereditary fructose intolerance.
  • Immunosuppression, whether congenital, idiopathic or as a result of corticosteroids systemically (at doses ≥ 20mg/d of prednisone), or due to radiation or antineoplastic older than 6 months.
  • History of thymic dysfunction (including thymoma and thymectomy).
  • For HIV + subjects: ART Celsentri or by other anti-CCR5, coinfection with HCV virus untreated
  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: NCT01426243

Locations
France
Voir Liste Des Centres
Paris, France
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Nathalie COLIN de VERDIERE Maladies Infectieuses St Louis Paris
Principal Investigator: Sophie MATHERON Maladies Infectieuses et Tropicales Bichat Paris
Principal Investigator: Odile LAUNAY CIC Cochin Paris
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier: NCT01426243     History of Changes
Other Study ID Numbers: 2009-014921-17
Study First Received: February 10, 2011
Last Updated: July 22, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Fever
Yellow Fever
Arbovirus Infections
Body Temperature Changes
Flaviviridae Infections
Flavivirus Infections
Hemorrhagic Fevers, Viral
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014