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The iHIVARNA strategy proposes using an mRNA-based therapeutic vaccine encoding HIV antigens as a novel and promising approach in HIV immunotherapy.

The four-year 6M€ European project iHIVARNA, funded by the European Commission, aims to successfully immunize antiretroviral-treated HIV-infected patients with 3 injections of the candidate universal HIV-TriMix-mRNA as an mRNA-based therapeutic vaccine with the final aim of improving the efficacy of therapeutic vaccination against HIV infection.
iHIVARNA is addressing the topic “Safety and efficacy of therapeutic vaccines” of the European Commission 7th Framework Programme Health 2013. The project brings together the expertise of a number of European groups (Spain, Belgium, and Netherlands) in dendritic cell targeting, rational design of immunogens, mRNA manufacturing and immuno-virological monitoring. This proposal continues the work in therapeutic vaccines performed in the last few years in the AIDS Research Unit of Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) leaded by Dr. Josep M Gatell and IrsiCaixa.

Dr. Josep M Gatell said: “Nowadays, over 30 million people worldwide are infected with HIV, most of them living in developing countries. Although combined antiretroviral therapy (cART) has proven to be highly effective to prevent clinical progression and death, by itself it is unable to eradicate the infection and other alternative approaches are urgently needed”. The consortium coordinator Dr. Felipe García, from IDIBAPS said: “Therapeutic vaccinations – vaccines targeting HIV infected patients with the ultimate aim of achieving a functional cure – have emerged as one of the most promising strategies that could restore HIV-specific T-cell responses in HIV infected patients and help them control viral replication without cART. Our novel therapeutic vaccine candidate is going to be tested for the first time in two phase I and phase IIa clinical trials to assess if it is a valid alternative to lifelong cART treatment.”
The iHIVARNA vaccine candidate is the result of a long lasting scientific track record of the Consortium. The candidate is based on an innovative approach that uses naked mRNA, so far has only been recently applied in the cancer research field.  The HIV-TriMix-mRNA has two parts: HIV that has been rationally designed by IrsiCaixa based on data from large international cohorts; and TriMix designed by Vrije Universiteit Brussel to activate and target dendritic cells to improve the HIV antigen presentation. The combination of mRNA, rationally designed HIV antigen and TriMix is a very innovative approach for a therapeutic vaccine and is expected to improve the results of other more traditional strategies already tested.
Studies included in iHIVARNA comprise 1) the manufacturing of the HIV-TriMix-mRNA in GMP conditions, 2) a phase I dose escalation clinical trial and a phase IIa-proof-of-concept clinical trial to test safety, efficacy and immunogenicity of the vaccine candidate, and 3) ascertaining immune and viral predictors and correlates of protection.
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