Argentine scientists advance a second-generation vaccine against coronavirus

Researchers from the Leloir Institute Foundation (FIL) and Conicet designed a second generation vaccine (those that appear in a second stage and are more sophisticated) against the coronavirus that has already induced a very powerful immune response in the laboratory and now, from an agreement with the biotechnology company Vaxinz, they seek to scale production and develop clinical trials.

“The second-generation concept is used in medicines, among which are vaccines, which appear in a second stage and evolve towards more elaborate and sophisticated products,” Osvaldo Podhajcer, project coordinator, head of the Therapy Laboratory, explained today to Télam. Molecular and Cellular (LTMC) from FIL and senior researcher from Conicet.

Podhajcer said that the vaccine under development “aims to be administered in a single dose, to have a longer lasting effect and to have a broad spectrum of protection against the appearance of new variants.”

So far, the vaccine has been tested in the laboratory with good results: “In preclinical studies, the vaccine generated a potent immune response against the SARS-CoV-2 virus in 100% of vaccinated animals and was maintained for at least 5 months without decay, “described Podhajcer.

Meanwhile Sabrina Vinzón, co-leader of the project and researcher at Conicet at FIL’s LTMC, described that “preclinical results in rodents showed that the vaccine induces as many antibodies that neutralize the virus as a cellular immune response (T lymphocytes) which is that allows long-term protection. “

Podhajcer’s group has decades of experience using adenovirus platforms for cancer therapy and a track record in developing experimental vaccines for human papillomavirus (HPV).

The candidate vaccine uses the non-replicating viral vector platform, that is, it takes a virus that does not produce serious health effects, modifies it genetically so that it does not replicate in the body and “introduces” a part of the virus against which it is wants to inoculate, in this case it is the Spike protein of the coronavirus.

“Our vaccine is based on a human adenovirus that causes a common cold, adenovirus 5 (similar to that of the second dose of Sputnik V), to which we have made modifications with parts of other human adenoviruses, so it is a hybrid”, he described Podhajcer.

The scientist indicated that the objective of the modifications “is to achieve a more powerful and protective immune response, at the same time as making production more efficient, in order to provide a greater number of doses in less time.”

In parallel, Podhajcer’s group developed a pseudovirus system that made it possible to demonstrate that the serum of immunized animals blocks the entry of SARS-CoV-2 into cells.

“The pseudovirus system has a single protein from the original SARS-CoV-2 (the Spike or Spike protein) and therefore they are called pseudovirus. They can infect but do not multiply and can be used in the biosafety conditions that our institution has. “, he detailed.

He also explained that “through the construction of these pseudoviruses we can reproduce the different variants that have appeared in recent months at a global level and define how effective our vaccines are to neutralize them, especially those identified in Manaus, South Africa and Great Britain, before the eventuality of having to produce complementary vaccines that protect against these or other variants “.

Podhajcer also pointed out that “simultaneously and in collaboration with the Paulista School of Medicine of the Federal University of São Paulo (EPM-Unifesp), Brazil, we have tested the neutralization of the live virus, and we were able to confirm an excellent neutralization profile, of the same way as with pseudoviruses. “

Recently, the Leloir Institute Foundation, Conicet and Vaxinz signed an agreement to “transform scientific development into a pharmaceutical product that can then be produced on an industrial scale under rigorous standards,” Julián Maggini, medical director of the biotech company.

Referring to the stage of development, Maggini indicated that “we already have results that show that our experimental vaccine is successful in developing a robust immune response.”

“The big question that we must solve today is how it protects us against the new variants that arise in our region, and this is our work today. Once that objective is reached, we will go into production with the vaccine optimized to cover the different variants. , in the course of this year, to begin the clinical tests below, for which we have already defined the design and agreed on its execution with the sites where they will be developed, “he added.

In this context of articulation with other institutions, the studies that will evaluate the efficacy of the vaccine in animals, a centerpiece of preclinical trials, will be developed at the National Administration of Laboratories and Institutes of Health (Anlis) “Dr. Carlos Malbrán” , dependent on the Ministry of Health of the Nation.

“The studies that we will carry out will seek to demonstrate its efficacy in laboratory animals using the live virus,” said Alexis Edelstein, director of the Anlis-Malbrán Biological Containment Operational Unit.

On the other hand, the Comparative Medicine Center (Conicet-Universidad Nacional del Litoral) in Esperanza, Santa Fe, headed by Hugo Ortega, director of the center and coordinated by Natalia Salvetti, responsible for quality control, is working on the design and execution of regulatory preclinical testing strategies to harmonize not only the requirements of Anmat, but also of other regulatory agencies.

Meanwhile, the design and execution of clinical phase 1 and 2 trials will be in charge of the Clinical Pharmacology Section of the Italian Hospital, led by Ventura Simonovich.

At an international level, in addition to the Paulista School of Medicine, the Laboratory for Studies in Virology and Viral Pathogenesis (LEVIP-Unifesp) also participates in the project, which will be in charge of carrying out the neutralization tests of the different variants, especially P.1 (Manaus).

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