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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections; Yellow Fever
• Intervention / Treatment: Biological: Yellow fever vaccination (STAMARIL)

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie COLIN DE VERDIERE; Phone Number: 01.42.02.66.45; Email: nathalie.colin-de-verdiere@aphp.fr
• Study Contact Backup: Name: Vincent MEIFFREDY; Phone Number: 01.45.59.52.06; Email: vincent.meiffredy@inserm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Biological: Yellow fever vaccination (STAMARIL); Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects
Other: 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.	Biological: Yellow fever vaccination (STAMARIL); Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immuno-virologic criterion	At Months 120 (10years), the antibody titers of neutralizers by PRNT (Plaque reduction neutralization test) and pseudotypes will be determined	At Months 120 (10years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predicting a sustained vaccine response 10 years later.	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.	At Months 120 (10years)

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Saint-Louis Hospital, Paris, France; Hôpital Cochin; Bichat Hospital
• Investigators: Principal Investigator: Odile LAUNAY, CIC Cochin Paris; Study Director: Nathalie COLIN de VERDIERE, Maladies Infectieuses St Louis Paris; Principal Investigator: Jade GHOSN, Hopital Bichat Paris

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Body Temperature Changes; Hemorrhagic Fevers, Viral; Fever; Yellow Fever
• Other Study ID Numbers: ANRS 0146s NovaaTen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No