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

ANRS, Emerging Infectious Diseases

Status: Not yet enrolling

Conditions: Yellow Fever; HIV Infections

Treatments: Biological: Yellow fever vaccination (STAMARIL)

Study type: Interventional

Funder types: Other

Identifiers

NCT05450770

ANRS 0146s NovaaTen

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

HIV+ GROUP

Active Comparator group

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).

Treatment:

Biological: Yellow fever vaccination (STAMARIL)

HIV- GROUP

Other group

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.

Treatment:

Biological: Yellow fever vaccination (STAMARIL)