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Clinical Trials/NCT05450770
NCT05450770
Not Yet Recruiting
N/A

The Yellow Fever Vaccine Immunity in HIV Infected Patients: Studies of Immunological Responses at 10 Years (ANRS 0146s NovaaTen)

ANRS, Emerging Infectious Diseases0 sites60 target enrollmentNovember 1, 2024
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ConditionsHIV InfectionsYellow Fever

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV Infections
Sponsor
ANRS, Emerging Infectious Diseases
Enrollment
60
Primary Endpoint
Immuno-virologic criterion
Status
Not Yet Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
November 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Predicting a sustained vaccine response 10 years later.(At Months 120 (10years))

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