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| Name | Class |
|---|---|
| Saint-Louis Hospital, Paris, France | OTHER |
| Bichat Hospital | OTHER |
| Hôpital Cochin | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yellow fever vaccination (STAMARIL) | Biological | Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects |
|
| 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) |
| 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. |
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Inclusion Criteria:
Subjects included in the ANRS EP 46 NOVAA trial:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie COLIN de VERDIERE | Maladies Infectieuses St Louis Paris | Study Director |
| Odile LAUNAY | CIC Cochin Paris | Principal Investigator |
| Jade GHOSN |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D015004 | Yellow Fever |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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.
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| At Months 120 (10years) |
| Hôpital Bichat Paris |
| Principal Investigator |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D001102 | Arbovirus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D006482 | Hemorrhagic Fevers, Viral |