Doctors Guillermo Docena and Omar Azzaroni, responsible for the development of ARGENVAC / UNLP
ARGENVAC, the vaccine against SARS-CoV-2 developed by scientists at the National University of La Plata, has entered its final phase and only remains to be tested in humans. This was announced by the main people responsible for the project in a meeting they held with the UNLP authorities.
During the meeting, which took place at the Rector’s Office, Guillermo Docena, researcher at the Institute of Immunological and Physiopathological Studies, and Omar Azzaroni, at the Institute of Theoretical and Applied Physicochemical Research – both belonging to the Faculty of Exact Sciences and CONICET – reported that in December 2023, the preclinical phase of the ARGENVAC study was successfully completed.
The researchers concluded this first stage after inoculating special mice, genetically modified to be sensitive to SARS-CoV-2 infection, and subsequently exposing them to the virus.
“In the studies we observed that mice inoculated with ARGENVAC do not get sick and do not die when exposed to the virus. This means that the vaccinated mice were able to control the infection compared to mice that were not vaccinated, which had a greater amount of virus in the nasal mucosa and lungs,” said Doctor of Exact Sciences, Guillermo Docena.
ARGENVAC is a vaccine that uses a nanoparticle that fulfills two functions simultaneously (vehicle and adjuvant) and an immunogen, which is the RBD protein, which stands for Receptor-binding Domain. This is the portion of the spike protein of the SARS-CoV-2 virus envelope with which the virus binds to the receptors of the cells it invades and then replicates inside them.
“Since January 2021, when we began the vaccine formulation and immunogenicity and safety studies in mice, we have studied the immunological mechanisms generated by the vaccine to induce protection. Based on the published results of the vaccines approved at that time in humans, we compared the mechanism of action of our ARGENVAC vaccine with the commercial ones and observed numerous similarities,” said the researcher.
“This led us to continue with the project, for which in these years we formed a solid public-private consortium in which the UNLP, UBA, CONICET and the Mar del Plata biotechnology company Gihon have worked together to carry out the design, characterization and finally industrial production, with the quality called GMP, for Good Manufacturing Product or Good Manufacturing Practices,” added the UNLP scientist.
Any product that is applied to humans must be obtained under GMP conditions and this is the condition, among others, that the ANMAT requires for the registration of products of this type. The Gihon company is the one in charge of obtaining the equipment, designing the plant and the procedures for its subsequent assembly and fitting out at the Mar del Plata Industrial Complex. Dr. Alberto Chevalier, CEO of the company, has joined the consortium, which is also made up of the groups led by Dr Omar Azzaroni (INIFTA, UNLP/CONICET), Dr Guillermo Docena (IIFP, UNLP/CONICET/CIC) and the Drs Cecila D’Alessio, Javier Santos and Alejandro Nadra (ib3, UBA).
The production of the vaccine has mainly been carried out in these three laboratories during its preclinical phase. However, to obtain ANMAT approval, it is necessary to have the production of the vaccine components and its final formulation under GMP conditions, as well as its packaging. Therefore, the next stage for ARGENVAC will consist of working on aspects related to its production.
2024-04-06 16:29:44
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