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

InnaVirVax33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

HIV-1 Infection

Interventions

VAC-3SBIOLOGICAL

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

PlaceboBIOLOGICAL

Comparison with experimental vaccine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (2)

Hopital Pitie Salpetriere

Paris, France

CIC Cochin Pasteur

Paris, France

Outcomes

Primary Outcomes

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).

Time frame: from D0 to week 24

Secondary Outcomes

Anti-3S antibody titers

Time frame: from D0 to week 60

Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load).

Time frame: from week 24 to week 60

NKp44L expression on the surface of CD4+ T lymphocytes

Time frame: 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.

Time frame: from D0 to week 60

Data from ClinicalTrials.gov

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