Phase I/IIa Dose-escalation Clinical Study of VAC-3S

Study Overview
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Brief Summary
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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.

Official Title
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Multicentre, Randomized, Placebo-controlled, Double-blind, Phase I/IIa Dose-escalation Clinical Study of a Therapeutic Vaccine (VAC-3S) Intended to Confer Protection Against Immunopathological Effects of HIV-1 in Infected Patients

Conditions
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HIV-1 Infection

Intervention / Treatment
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* Biological: VAC-3S
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose VAC-3S<br> | Biological: VAC-3S<br>* 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<br>|
| Experimental: Medium dose VAC-3S<br> | Biological: VAC-3S<br>* 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<br>|
| Experimental: High dose VAC-3S<br> | Biological: VAC-3S<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Comparison with experimental vaccine<br>|
| Experimental: Double-dose VAC-3S<br> | Biological: VAC-3S<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, HIV, immunotherapy, active immunotherapy, vaccine, virulence, innate immunity, NK cells