EU Grants a Project to Test an Innovative HIV Vaccine Candidate in two phase I/IIa clinical trials

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 IDIBAPS leaded by Dr. Josep M Gatell and the Institute for AIDS Research IrsiCaixa. Dr. Felipe García, from IDIBAPS, is the coordinator of the iHIVARNA Consortium.

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.

Project Information: The iHIVARNA project (full title: Therapeutic TriMIx / mRNA based Vaccine in Chronic HIV-1 Infected Patients on Antiretroviral Therapy) is funded with approximately 6 million Euro granted by the European Commission in the 7th Framework Programme, coordinated by Dr. Felipe García of IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer) and carried out by 8 leading research institutions and SMEs.

iHIVARNA started the 1st December 2013, with a duration of 48 months.

The full list of participating institutions is:

  • Consorcio Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
  • Instituut voor Tropische Geneeskunde (ITM)
  • Vrije Universiteit Brussel (VUB)
  • eTheRNA BVBA (eTheRNA)
  • Erasmus Universitair Medisch Centrum Rotterdam (EMC)
  • Instituto de Investigación del Sida IrsiCaixa
  • Synapse Research Management Partners S.L. (SYNAPSE)
  • Asphalion, S.L. (ASPHALION)