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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05450770
Recruitment Status : Not yet recruiting
First Posted : July 11, 2022
Last Update Posted : July 11, 2022
Sponsor:
Collaborators:
Saint-Louis Hospital, Paris, France
Bichat Hospital
Hôpital Cochin
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Study Description
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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

Condition or disease Intervention/treatment Phase
HIV Infections Yellow Fever Biological: Yellow fever vaccination (STAMARIL) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: The Yellow Fever Vaccine Immunity in HIV Infected Patients: Studies of Immunological Responses at 10 Years (ANRS 0146s NovaaTen)
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Stamaril

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: HIV+ GROUP

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).

 Biological: Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects
HIV- GROUP

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.

 Biological: Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects


Outcome Measures
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Primary Outcome Measures :
  1. Immuno-virologic criterion [ Time Frame: At Months 120 (10years) ]
    At Months 120 (10years), the antibody titers of neutralizers by PRNT (Plaque reduction neutralization test) and pseudotypes will be determined


Secondary Outcome Measures :
  1. Predicting a sustained vaccine response 10 years later. [ Time Frame: At Months 120 (10years) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05450770


Contacts
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Contact: Nathalie COLIN DE VERDIERE 01.42.02.66.45 nathalie.colin-de-verdiere@aphp.fr
Contact: Vincent MEIFFREDY 01.45.59.52.06 vincent.meiffredy@inserm.fr

Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
Saint-Louis Hospital, Paris, France
Bichat Hospital
Hôpital Cochin
Investigators
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Study Director: Nathalie COLIN de VERDIERE Maladies Infectieuses St Louis Paris
Principal Investigator: Odile LAUNAY CIC Cochin Paris
Principal Investigator: Jade GHOSN Hôpital Bichat Paris
More Information
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT05450770    
Other Study ID Numbers: ANRS 0146s NovaaTen
First Posted: July 11, 2022    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Yellow Fever
Fever
Infections
RNA Virus Infections
Virus Diseases
Body Temperature Changes
 Arbovirus Infections
Vector Borne Diseases
Flavivirus Infections
Flaviviridae Infections
Hemorrhagic Fevers, Viral