Dec 1 2013
InnaVirVax SA today announced the initiation of a Phase 2 clinical trial assessing the therapeutic properties of the VAC-3S vaccine when combined with standard antiretroviral therapy (ART) in the course of HIV-1 infection.
"On this World AIDS Day, the advancement of VAC-3S into this Phase 2 study is an important step forward. We recognize we have much work to do towards the goal of durable treatments for patients and their families affected by HIV, and our company is rising to meet this challenge," said Shahin Gharakhanian, MD, InnaVirVax Chief Medical Officer.
The primary objective of the Phase 2 study is to assess antibody response to the VAC-3S vaccine. VAC-3S has been constructed to induce a humoral immune response against a highly conserved region of the gp41envelope protein of the HIV-1 known as 3S. A complement to ART, VAC-3S is a therapeutic vaccine candidate that acts on the immune system via CD4+ T-cells, a key factor responsible for progression of the disease during HIV-1 infection. Notably, data available from human cohort studies and/or non-human primate models indicate anti-3S antibodies are associated to an increase in CD4+ T cells and a decrease of HIV viral reservoirs as well as HIV inflammatory biomarkers. VAC-3S is composed of three distinct but covalently linked parts so as to optimize production of an immune response. Secondary objectives include overall general and local tolerance as well as clinical safety, comprehensive evaluation of the immunological endpoints, inflammatory biomarkers, HIV reservoir, as well as identifying the vaccine's immunogenic characteristics.
A phase I dose escalation study of VAC-3S previously performed in 33 patients living with HIV whose CD4 T-lymphocyte levels were higher than 200 mm3 and who were on ART, demonstrated safety and provided data for dose selection.
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