The first phase of clinical trials of the SpiN-Tec vaccine against covid-19 has shown positive results. Developed by researchers from the Federal University of Minas Gerais (UFMG) and the Oswaldo Cruz Foundation (Fiocruz), it is the first 100% national vaccine, as it does not depend on technology transfer or importation. Preliminary data indicate that it did not present safety problems with volunteers and has the potential to generate an immune response to the virus that causes the disease. 
After going through the pre-clinical phase, when tests carried out on laboratory animals showed no side effects, the clinical phase 1 began in November last year. Until March of this year, the vaccine was applied to 36 people, aged between 18 and 54 years. The data are being analyzed by the researchers and should be presented later this month to the National Health Surveillance Agency (Anvisa).
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The expectation is that clinical phase 2 will start in early June with 372 volunteers between 18 and 85 years old. They need to have been vaccinated with two initial doses of the CoronaVac or AstraZeneca vaccine, and one or two booster doses of Pfizer or AstraZeneca. Those who took the bivalent vaccine cannot participate in this phase. Having had covid-19 is not an impediment, as long as it occurred more than six months ago. In phase 2, the focus of the tests is on immunogenicity, that is, verifying the level of antibodies generated and the response of lymphocytes in protecting the body.
The information comes from Helton Santiago, coordinator of the clinical trials of the vaccine and professor at the Department of Biochemistry and Immunology at the Institute of Biological Sciences (ICB) at UFMG. He explains that, contrary to what happened in the tests of the first vaccines against covid-19, this time the objective is to test the effectiveness of SpiN-Tec as a booster dose.
“It would be very difficult, at this moment, to go after the few in Brazil who have not been vaccinated with any dose. The strategy of CT Vacinas at UFMG was to develop an immunizer that serves as a booster. Ours has the differential of focusing on cellular immunity. When neutralizing antibodies fail, it is the cellular immunity that holds the infection down and lightens it. So, we believe that this vaccine will be ideal to protect against new variants. While others will lose effectiveness, ours does not let variants escape immunity.”
next steps
The schedule foresees the start of phase 3 in December of this year or in January 2024. By the beginning of 2025, the vaccine may be available to the population. The tests rely on investments from different sources: the State of São Paulo Research Foundation (FAPESP), the Virus Network of the Ministry of Science, Technology and Innovation (MCTI), the Belo Horizonte City Hall and the Research Support Foundation of the State of Minas Gerais (Fapemig).
Helton Santiago reinforces that it is necessary to be patient with possible date adjustments. As this is the first time that a vaccine of this type has been produced in Brazil, the tests are more subject to unforeseen circumstances and obstacles due to lack of prior experience.
“We are learning about what it takes to get a vaccine out of basic research and into clinical research. And we are facing several bottlenecks in Brazilian science and solving them in the best possible way. So, many times, we plan a schedule and face situations that sometimes we didn’t even know existed”, explains Helton. “There is no shortage of resources for the walk. The obstacles are really technical. We need to create structures, create rehearsals, create know-how to win several stages that Brazil did not have the expertise necessary”.
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