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

NCT ID: NCT05450770

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2024-11-01

Brief Summary

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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

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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.

Conditions

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HIV Infections Yellow Fever

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Yellow fever vaccination (STAMARIL)

Intervention Type BIOLOGICAL

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.

Group Type OTHER

Yellow fever vaccination (STAMARIL)

Intervention Type BIOLOGICAL

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

Interventions

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Yellow fever vaccination (STAMARIL)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saint-Louis Hospital, Paris, France

OTHER

Sponsor Role collaborator

Bichat Hospital

OTHER

Sponsor Role collaborator

Hôpital Cochin

OTHER

Sponsor Role collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie COLIN de VERDIERE

Role: STUDY_DIRECTOR

Maladies Infectieuses St Louis Paris

Odile LAUNAY

Role: PRINCIPAL_INVESTIGATOR

CIC Cochin Paris

Jade GHOSN

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bichat Paris

Central Contacts

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Nathalie COLIN DE VERDIERE

Role: CONTACT

01.42.02.66.45

Vincent MEIFFREDY

Role: CONTACT

01.45.59.52.06

Other Identifiers

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ANRS 0146s NovaaTen

Identifier Type: -

Identifier Source: org_study_id

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