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

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05450770

Enrollment

Registered

2022-07-11

Start date

2024-11-01

Completion date

2024-11-01

Last updated

2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Yellow Fever

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.

Interventions

BIOLOGICALYellow fever vaccination (STAMARIL)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactNathalie COLIN DE VERDIERE

nathalie.colin-de-verdiere@aphp.fr01.42.02.66.45

Backup ContactVincent MEIFFREDY

vincent.meiffredy@inserm.fr01.45.59.52.06

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026