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The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with undetectable viral loads.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose VAC-3S | Experimental |
| |
| Medium dose VAC-3S | Experimental |
| |
| High dose VAC-3S | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Double-dose VAC-3S | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAC-3S | Biological | Comparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table. | Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load). | from D0 to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-3S antibody titers | from D0 to week 60 | |
| Number of Study Participants Who Tolerated three vaccinations with VAC-3S at 4-weeks apart Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table. |
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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 |
|---|---|---|---|---|---|---|
| Hopital Pitie Salpetriere | Paris | 75013 | France | |||
| CIC Cochin Pasteur |
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| Label | URL |
|---|---|
| Sponsor's website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 24, 2017 | |
| Reset | Jul 27, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 24, 2017 | Jul 27, 2018 |
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| Placebo | Biological | Comparison with experimental vaccine |
|
Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).
| from week 24 to week 60 |
| NKp44L expression on the surface of CD4+ T lymphocytes | from D0 to week 60 |
| Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation. | from D0 to week 60 |
| Paris |
| 75014 |
| France |