About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Non-volunteers for the 10-year follow-up
Subject under curatorship, guardianship or safeguard of justice.
Trial design
Parallel
Treatments tested in this trial
Yellow fever vaccination (STAMARIL)
Biological/VaccineYellow fever vaccination (STAMARIL) for HIV positive and negative subjects
Treatment groups
Trial outcomes
Primary outcomes
Immuno-virologic criterion
At Months 120 (10years), the antibody titers of neutralizers by PRNT (Plaque reduction neutralization test) and pseudotypes will be determined
Secondary outcomes
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.
Locations
Sponsors and contacts
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ANRS, Emerging Infectious Diseases
Lead sponsor
Saint-Louis Hospital, Paris, France
Collaborator
Bichat Hospital
Collaborator
Hôpital Cochin
Collaborator
This trial is not recruiting at the moment. You can still explore other options: