Clinical trial

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

Name
ANRS 0146s NovaaTen
Description
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
Trial arms
Trial start
2024-01-01
Estimated PCD
2024-11-01
Trial end
2024-11-01
Status
Not yet recruiting
Treatment
Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects
Arms:
HIV+ GROUP, HIV- GROUP
Size
60
Primary endpoint
Immuno-virologic criterion
At Months 120 (10years)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-12-01

1 organization

1 product

2 indications

Indication
HIV Infections
Indication
Yellow fever