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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002735-23 | EudraCT Number |
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The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAC-3S 16µg/administration | Active Comparator | VAC-3S 16µg/ml administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination. |
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| VAC-3S Placebo | Placebo Comparator | VAC-3S placebo administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination. |
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| VAC-3S 32 µg/administration | Active Comparator | VAC-3S 32µg/ml administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination. |
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| VAC-3S 64 µg/administration | Active Comparator | VAC-3S 64µg/ml administered every 4 weeks for 3 months without maintenance vaccination. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAC-3S | Biological | VAC-3S is administered via intra-muscular route in the arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| anti-3S antibodies titer | From D0 to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| tolerance to 6 vaccinations of VAC-3S | safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) adverse events (AEs) grading table.Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load, CD4 and CD8 counts) | From D0 to week 72 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphael Ho Tsong Fang, DVM PhD | InnaVirVax | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Sud Francilien | Corbeil-Essonne | 91106 | France | |||
| Hôpital de la Croix Rousse |
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| blood inflammatory marker concentrations | Inflammatory markers include: Highly sensitive C-reactive protein (hsCRP), Highly sensitive Recombinant human interleukin 6 (hsIL-6), Soluble CD14 (sCD14), Soluble CD163 (sCD163), D-dimer, Interferon (IFN)-gamma inducible protein 10 (IP-10), Tumor necrosis factor receptor 1 (sTNFR1) and 2 (sTNFR2), Immunoglobulin G (IgG), | From D0 to week 72 |
| immunogenic characteristics of VAC-3S | anti-3S antibody titers and determination of anti-3S antibody isotypes and avidity | From D0 to week 72 |
| lymphocyte phenotype markers | Phenotype markers include: Nkp44L expression on the surface of CD4+ T lymphocytes, phenotypic markers of of lymphocyte differentiation and activation | From D0 to week 72 |
| secondary virological effects | 3S gp41 sequences and proviral HIV reservoir | From D0 to week 72 |
| Lyon |
| 69317 |
| France |
| Hôpital Gui de Chauliac | Montpellier | 34295 | France |
| Hôpital Saint-Antoine | Paris | 75012 | France |
| Hôpital Pitié Salpêtrière | Paris | 75013 | France |
| Hôpital Cochin Saint Vincent de Paul | Paris | 75014 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Hôpital Bichat - Claude Bernard | Paris | 75018 | France |
| Hôpital Tenon | Paris | 75020 | France |
| Jürgen Rockstroh | Bonn | 53105 | Germany |
| Gerd Fätkenheuer | Cologne | 63225 | Germany |
| Hospital Clinic University of Barcelona | Barcelona | 08036 | Spain |