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Immunity to Yellow Fever in HIV-infected Patients 10 Years After a Primary Anti-yellow Fever Vaccination

Primary Purpose

HIV Infections, Yellow Fever

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yellow fever vaccination (STAMARIL)
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects included in the ANRS EP 46 NOVAA trial:

    • 40 HIV positive subjects from consultations for infectious diseases and travel medicine centers at Saint-Louis, Cochin-Pasteur and Bichat hospitals (on HAART for at least one year and not modified in the 3 months preceding the pre-inclusion visit, CD4 > 350/mm3 and a viral load <50 copies / mL for at least 6 months).
    • 20 HIV negative subjects from the consultation of travelers from Saint-Louis, Bichat and Cochin-Pasteur hospitals.
    • Subjects agreeing to be monitored according to the terms of the protocol.
    • Subjects affiliated to a Social Security scheme or beneficiaries of such a scheme.
    • Signature of informed consent.

Exclusion Criteria:

  • Non-volunteers for the 10-year follow-up
  • Subject under curatorship, guardianship or safeguard of justice.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    HIV+ GROUP

    HIV- GROUP

    Arm Description

    Subjects included in the ANRS EP 46 NOVAA trial: • 40 HIV positive subjects from consultations for infectious diseases and travel medicine centers at Saint-Louis, Cochin-Pasteur and Bichat hospitals (on HAART for at least one year and not modified in the 3 months preceding the pre-inclusion visit, CD4 > 350/mm3 and a viral load <50 copies / mL for at least 6 months).

    Subjects included in the ANRS EP 46 NOVAA trial: • 20 HIV negative subjects from the consultation of travelers from Saint-Louis, Bichat and Cochin-Pasteur hospitals.

    Outcomes

    Primary Outcome Measures

    Immuno-virologic criterion
    At Months 120 (10years), the antibody titers of neutralizers by PRNT (Plaque reduction neutralization test) and pseudotypes will be determined

    Secondary Outcome Measures

    Predicting a sustained vaccine response 10 years later.
    To study the effect of clinical and biological factors in HIV+ patients (collection of data on: age; clinical examination; heart rate; weight; body temperature; blood pressure; CD4, CD8 and the CD4/CD8 ratio; the nadir and zenith of CD4; the duration of antiretroviral treatment; the duration of HIV infection) on the PRNT titers transformed into logarithm and the percentages of neutralization at ten years, uni and multivariate regressions are used.

    Full Information

    First Posted
    June 14, 2022
    Last Updated
    August 24, 2023
    Sponsor
    ANRS, Emerging Infectious Diseases
    Collaborators
    Saint-Louis Hospital, Paris, France, Bichat Hospital, Hôpital Cochin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05450770
    Brief Title
    Immunity to Yellow Fever in HIV-infected Patients 10 Years After a Primary Anti-yellow Fever Vaccination
    Official Title
    The Yellow Fever Vaccine Immunity in HIV Infected Patients: Studies of Immunological Responses at 10 Years (ANRS 0146s NovaaTen)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ANRS, Emerging Infectious Diseases
    Collaborators
    Saint-Louis Hospital, Paris, France, Bichat Hospital, Hôpital Cochin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    ANRS 0146s NovaaTen study aims to determine the vaccine responses in the participants of the ANRS EP46 Novaa trial 10 years after a primary anti-yellow fever vaccination
    Detailed Description
    The vaccine responses will be determined with the measurement of the neutralizing antibody titers using the neutralization tests PRNT and Pseudo type ACN 400 to M120 (ten years) in the participants of the ANRS EP 46 NOVAA trial, VIH+ and controls naïve to previous vaccination ten years after a primary anti-yellow fever vaccination.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections, Yellow Fever

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Category 2, multi-centric intervention research comparing 2 parallel groups of 40 HIV + subjects and 20 HIV- subjects included in the ANRS EP46 NOVAA trial.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HIV+ GROUP
    Arm Type
    Active Comparator
    Arm Description
    Subjects included in the ANRS EP 46 NOVAA trial: • 40 HIV positive subjects from consultations for infectious diseases and travel medicine centers at Saint-Louis, Cochin-Pasteur and Bichat hospitals (on HAART for at least one year and not modified in the 3 months preceding the pre-inclusion visit, CD4 > 350/mm3 and a viral load <50 copies / mL for at least 6 months).
    Arm Title
    HIV- GROUP
    Arm Type
    Other
    Arm Description
    Subjects included in the ANRS EP 46 NOVAA trial: • 20 HIV negative subjects from the consultation of travelers from Saint-Louis, Bichat and Cochin-Pasteur hospitals.
    Intervention Type
    Biological
    Intervention Name(s)
    Yellow fever vaccination (STAMARIL)
    Intervention Description
    Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects
    Primary Outcome Measure Information:
    Title
    Immuno-virologic criterion
    Description
    At Months 120 (10years), the antibody titers of neutralizers by PRNT (Plaque reduction neutralization test) and pseudotypes will be determined
    Time Frame
    At Months 120 (10years)
    Secondary Outcome Measure Information:
    Title
    Predicting a sustained vaccine response 10 years later.
    Description
    To study the effect of clinical and biological factors in HIV+ patients (collection of data on: age; clinical examination; heart rate; weight; body temperature; blood pressure; CD4, CD8 and the CD4/CD8 ratio; the nadir and zenith of CD4; the duration of antiretroviral treatment; the duration of HIV infection) on the PRNT titers transformed into logarithm and the percentages of neutralization at ten years, uni and multivariate regressions are used.
    Time Frame
    At Months 120 (10years)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects included in the ANRS EP 46 NOVAA trial: 40 HIV positive subjects from consultations for infectious diseases and travel medicine centers at Saint-Louis, Cochin-Pasteur and Bichat hospitals (on HAART for at least one year and not modified in the 3 months preceding the pre-inclusion visit, CD4 > 350/mm3 and a viral load <50 copies / mL for at least 6 months). 20 HIV negative subjects from the consultation of travelers from Saint-Louis, Bichat and Cochin-Pasteur hospitals. Subjects agreeing to be monitored according to the terms of the protocol. Subjects affiliated to a Social Security scheme or beneficiaries of such a scheme. Signature of informed consent. Exclusion Criteria: Non-volunteers for the 10-year follow-up Subject under curatorship, guardianship or safeguard of justice.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nathalie COLIN DE VERDIERE
    Phone
    01.42.02.66.45
    Email
    nathalie.colin-de-verdiere@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vincent MEIFFREDY
    Phone
    01.45.59.52.06
    Email
    vincent.meiffredy@inserm.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nathalie COLIN de VERDIERE
    Organizational Affiliation
    Maladies Infectieuses St Louis Paris
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Odile LAUNAY
    Organizational Affiliation
    CIC Cochin Paris
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jade GHOSN
    Organizational Affiliation
    Hôpital Bichat Paris
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Immunity to Yellow Fever in HIV-infected Patients 10 Years After a Primary Anti-yellow Fever Vaccination

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