Last Friday, the first three volunteers received a dose of the vaccine against Covid-19 SpiN-TEC, created by the Vaccines Center of the Federal University of Minas Gerais (CTVacinas / UFMG), in partnership with Fiocruz Minas and the Ministry of Science, Technology and Innovation (MCTI). The event marked the beginning of phase 1 of clinical trials of the immunizer, the first developed entirely with national technology and inputs.
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UFMG received approval from the National Health Surveillance Agency (Anvisa) in October to begin the stage of clinical studies with humans, after the so-called pre-clinical tests, in the laboratory and with animals, have proven the safety and induction of defenses against Sars-CoV-2, the virus that causes Covid-19.
Clinical studies with volunteers are done in three stages. In this first one, which officially started on the 25th, 72 volunteers are randomly divided into two groups, in which one receives the new vaccine and the other the application of Oxford / AstraZeneca, without knowing which injection is administered.
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It is expected to last until March 2023, when researchers will evaluate the ideal dosage and immunogenicity – the ability to induce the production of antibodies and defense cells. Then, in the second phase, 360 participants will be divided in the same way to evaluate the best dose schedule and confirm the safety of the vaccine.
If the results of both stages are positive, the scientists will send the data to Anvisa to request the green light to begin the last phase of clinical trials on humans. If approved, it will have a total of four to five thousand volunteers.
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It is at this stage that a greater number of participants are involved in the tests so that researchers can actually compare the incidence of the disease and serious cases between those who received the vaccine and those who did not. It should be closed by the end of the first half of 2024, when researchers will know the effectiveness of the immunizer – and will be able to request its use from the regulatory agency.
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The clinical trials are coordinated by professors Helton Santiago, from the Institute of Biological Sciences, and Jorge Andrade Pinto, from the Faculty of Medicine, both from UFMG. For the pre-clinical stages, in the laboratory, and the first two with humans, the MCTI invested a total of BRL 16 million. The project also received funding from the city of Belo Horizonte and the government of Minas Gerais.
Effective for new variants
Despite the advancement of Omicron and its multiple subvariants, such as the most recent one, BQ.1, the scientists behind SpiN-TEC believe that the new application should induce a more robust immune response against Sars-CoV-2. This is because the virus mutations occur mainly in the S protein, part that the pathogen uses to connect to the human cell and which is the target of current doses.
However, the new vaccine also uses the N protein in its formulation, which remained more conserved even after the mutations. For this, the scientists developed a molecule that unites the two proteins, which was named Spin. With this, they believe that the application will induce a better production of defense cells called T lymphocytes to fight the virus.
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Furthermore, if the vaccine proves to be in fact effective, it will be a milestone as the first vaccine developed entirely in Brazil, which will open doors for the creation of other applications that protect against diseases that cannot yet be prevented in the country, such as malaria. .
— All the vaccines we have today in the National Immunization Plan (PNI) come from technology transfer from abroad. We don’t have a history of vaccines from early development to the patient’s arm. So, I believe that our new vaccine can be an important milestone in Brazilian research and in the field of vaccines, as it shows that Brazil has this capacity and can serve as a legacy for other vaccines to come for other diseases,” said the professor at the Department of Biochemistry. and Immunology from the Institute of Biological Sciences at UFMG, and coordinator of CTVacinas, Ricardo Gazzinelli, in August, during an interview with GLOBO.
Another Brazilian vaccine for Covid-19
Also in October, another vaccine for Covid-19 at a more advanced stage in Brazil received approval from Anvisa to start the second phase of clinical studies. The vaccine, called MCTI CIMATEC HDT RNA, was developed by the Senai Cimatec center in Bahia, with support from the MCTI and in partnership with the company HDT Bio Corp, from the United States, and the pharmaceutical company Gennova Biopharmaceuticals, from India.
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If it proves to be effective, the vaccine will be the first for the new coronavirus that was developed at least in part in a Brazilian center. It is not considered entirely national because, while SpiN-TEC’s technology was 100% created in the country, the candidate from Bahia relies on international partnerships.
To give the green light to the next stage of testing, Anvisa analyzed data from phase 1 of the studies – which began in January of this year and attested to the safety of the vaccine – in addition to information from the pre-clinical stages in the laboratory and with animals.
In an interview with GLOBO last month, the infectologist and chief researcher at Senai Cimatec, Roberto Badaró, who leads the research on the immunizer, said that the expectation is that the studies will be completed by the end of next year. With that, if the results are positive, the application will be ready to be evaluated by Anvisa and incorporated into the country’s vaccination campaign in 2024.
— (The expectation is that) we will have phase 3 completed by the end of 2023. In 2024, the vaccine will already be available to enter a vaccination schedule that can be prepared by the Ministry of Health for application as reinforcements — said Badaró.