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

NCT05450770 | Not Yet Recruiting

• 1 other identifier: ANRS 0146s NovaaTen
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

HIV Infections; Yellow Fever

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Predicting a sustained vaccine response 10 years later.

  At Months 120 (10years)

Study Arms (2)

HIV+ GROUP

ACTIVE COMPARATOR

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)

HIV- GROUP

OTHER

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)

Interventions

Yellow fever vaccination (STAMARIL) BIOLOGICAL

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

HIV+ GROUP; HIV- GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects included in the ANRS EP 46 NOVAA trial:
• 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.

You may not qualify if:

• Non-volunteers for the 10-year follow-up
• Subject under curatorship, guardianship or safeguard of justice.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Saint-Louis Hospital, Paris, France: collaborator
• Bichat Hospital: collaborator
• Hôpital Cochin: collaborator

MeSH Terms

Conditions

HIV Infections; Yellow Fever

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral

Study Officials

• Nathalie COLIN de VERDIERE

  Maladies Infectieuses St Louis Paris

  STUDY DIRECTOR

• Odile LAUNAY

  CIC Cochin Paris

  PRINCIPAL INVESTIGATOR

• Jade GHOSN

  Hôpital Bichat Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie COLIN DE VERDIERE

CONTACT

01.42.02.66.45; nathalie.colin-de-verdiere@aphp.fr

Vincent MEIFFREDY

CONTACT

01.45.59.52.06; vincent.meiffredy@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: July 11, 2022
• Study Start: November 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07