HIV-1 Infection
Conditions
Keywords
HIV-1, HIV, immunotherapy, active immunotherapy, vaccine, virulence, innate immunity, NK cells
Brief summary
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.
Interventions
BIOLOGICALVAC-3S
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
BIOLOGICALPlacebo
Comparison with experimental vaccine
Sponsors
InnaVirVax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* HIV-1 infected patient * Age between 18 and 55 years * ART (AntiRetroviral Therapy) initiation 1 year ago * Plasma HIV RNA below 50 copies per ml on three sequential occasions including V-1 in the past 12 months * CD4 T cell count above or equal to 200 cells per mm3, * Nadir CD4 T cell count above or equal to 100 cells per mm3, * Contraception in women with child-bearing potential
Exclusion criteria
* Any ART change within a month preceding screening. * Chronic active liver disease, HIV-Hepatitis Coinfection. * Immunotherapy in the past year, immunosuppressive treatment within the past month. * History of auto-immune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | from D0 to week 24 | Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | from week 24 to week 60 | Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load). |
| 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 | — |
Countries
France
Outcome results
None listed