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

Not Applicable

Not yet recruiting

• Conditions: Yellow Fever; HIV Infections
• Interventions: Biological: Yellow fever vaccination (STAMARIL)

• Registration Number: NCT05450770
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Start: 2024-11-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV- GROUP	Yellow fever vaccination (STAMARIL)	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.
HIV+ GROUP	Yellow fever vaccination (STAMARIL)	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).

Primary Outcome Measures

Name	Time	Method
Immuno-virologic criterion	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

Name	Time	Method
Predicting a sustained vaccine response 10 years later.	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.