InnaVirVax SA, a biopharmaceutical company researching and developing therapeutic and diagnostic solutions for diseases linked to the immune system, has begun a phase II clinical trial assessing the therapeutic properties of the VAC-3C vaccine when combined with standard antiretroviral therapy (ART) in the course of HIV-1 infection.
“On this World AIDS Day, the advancement of VAC-3C into this phase II study is an important step forward. We recognise 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, Inn aVirVax chief medical officer.
The primary objective of the phase II 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 f or progression of the disease during HIV-1 infection. Notably, data available from human cohor t studies and/or non-human primate models indicate anti-3S antibodies are associated t o an increase in CD4+ T cells and a decrease of HIV viral reservoirs as well as HIV inf lammatory biomarkers. VAC-3S is composed of three distinct but covalently linked pa rts so as to optimize production of an immune response.
Secondary objectives include overa ll general and local tolerance as well as clinical safety, comprehensive evaluation of the im munological endpoints, inflammatory biomarkers, and identifying the vaccine’s immunogen ic characteristics. A phase I dose escalation study of VAC-3S previousl y performed in 33 patients living with HIV whose CD4 T-lymphocyte levels were higher than 200 mm and who were on ART, demonstrated safety and provided data for dose sele ction.
The phase II study is a randomized, double-blind, pl acebo-controlled study among HIV-1 infected adults with viral load less than or equal to 50 copies/mm treated with ART, whose CD4+ T-cell count at screening is between 200 and 5 00 cells/mm. A total of 90 patients will be studied in France, Germany and Spain. Three VAC- 3S doses will be compared. First a three months base vaccination will be performed; then 3 - maintenance injections in two of three dosage groups and a six-month follow-up period.
“We’ve assembled a blue ribbon International US / EU Clinical Advisory Board to guide us and highly experienced group of clinical investigat ors and stellar network of reference laboratories to conduct assessments. Coordinating principal investigators for the three countries are Professors Christine Katlama, Paris, France, Juergen Rockstroh in Bonn, Germany and José Gatell in Barcelona, Spain ( co-chair of 2013 AIDS vaccine conference ). InnaVirVax thus marks this World AIDS day with a very innovative programme to meaningfully address this challenging infection,” said Joel Crou zet, CEO of InnaVirVax.