Barcelona, March 2017
Pre-clinical studies were conducted at the beginning of iHivarna project to comply with regulatory requirements and fulfill phase I clinical trial application and the final results have recently been published in AIDS. Thus, we are happy to announce the results are public and available as well as an editorial comment about it.
Do not hesitate to look up for them:
- Guardo AC, Joe PT, Miralles L, Bargalló ME, Mothe B, Krasniqi A, Heirman C, García F, Thielemans K, Brander C, Aerts JL, Plana M; iHIVARNA consortium. Preclinical evaluation of an mRNA HIV vaccine combining rationally selected antigenic sequences and adjuvant signals (HTI-TriMix). AIDS. 2017 Jan 28;31(3):321-332. doi: 10.1097/QAD.
- Ahmad A, Rinaldo CR. A novel anti-HIV immunotherapy to cure HIV. AIDS. 2017 Jan 28;31(3):447-449. doi: 10.1097/QAD.
In this article, it is presented and discussed a preclinical evaluation a novel mRNA and dendritic cell-based formulation, where a combination of 2 selected antigenic sequences and adjuvant signals (HTI + TriMix) can induce a potent immune response in vitro and in vivo. The published results are a major advancement toward developing immunotherapy that is effective and scalable for HIV-infected patients.
iHIVARNA was the first EU-funded project we participated in. The principal aim of iHIVARNA is 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 objective of achieving a functional cure of HIV infection. In order to fulfil this aim, the planned steps of the Project have been:
– The manufacturing of the HIV-TriMix-mRNA in GMP conditions to be used in clinical trials.
– A phase I dose escalation clinical trial and a phase II a-proof-of-concept clinical trial to test safety, efficacy and immunogenicity of the vaccine candidate.
– Ascertaining immune and viral predictors and correlates of protection.
– Asphalion participates in iHIVARNA project as a regulatory partner by developing and conducting the
· Preparation of IBs and IMPDs
· Design of regulatory toxicology studies
· Revision of Phase I clinical results
· Regulatory Support during development
You can follow the project status and check for more information on www.ihivarna.org.
iHIVARNA: The research leading to this results has received funding from the European Comunity’s Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 602570.
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