COVID-19: Anvisa authorizes Fiocruz and UFMG to test SpiN-TEC vaccine in humans

SpiN-TEC, a COVID-19 vaccine developed by Fiocruz Minas and by the Federal University of Minas Gerais (UFMG), can begin to be tested in humans. Last Monday (October 3), the Brazilian Health Surveillance Agency (Anvisa) authorized the beginning of the so-called clinical trials. From now on, researchers can move on to the step that evaluates the safety and the immune response generated by the vaccine.

In this new phase, the immunizer will be applied to subjects who volunteer to take part in the study. Anyone interested may register on an online platform which will be announced soon. According to the UFMG researcher and coordinator of the clinical trials, Helton Santiago, a total of 432 volunteers will be selected. Of these, 72 will be selected for phase I, with the goal of evaluating vaccine safety, verifying possible side effects, such as headache, local pain, fever, nausea, among others. Phase II will include 360 volunteers and will be evaluating, in addition to safety, the level of antibodies generated by the vaccine and lymphocyte response; together, they may ensure protection against infection by COVID-19. Each participant will be followed by the clinical team of the research for a year, but it will not be necessary to wait all this time before moving on to phase II, which should begin from four to six months after the beginning of phase I.

In both stages, volunteers will be divided in two groups: one with subjects between 18 and 54 years old, and the other with subjects between 55 and 85 years old. The goal of the researchers is to evaluate whether age may interfere with the immune response and with the safety of the vaccine. The tests will always begin with the youngest group and then move on to the group of older people.

“This was the work of a team of more than 20 researchers with links to the Vaccine Technology Center (Fiocruz/UFMG). From among them, Graziella Rivelli, Santuza Teixeira, Ana Paula Fernandes, Natalia Salazar, Nalalia Houmo-Souza, Júlia Castro and Helton Santiago have played a crucial role, says Ricardo Gazzinelli, researcher of Fiocruz Minas and UFMG, who coordinated the project. According to Gazzinelli, the proposal of the SpiN-TEC is to work as a booster shot, as most of the population has already been vaccinated with other immunizers. During the tests, the vaccine will be evaluated by means of immunological markers and its efficacy must be equal or superior to that of vaccines already in the market.

Assays will begin as soon as the National Commission of Ethics in Research (Conep) revalidates the approval that was previously granted. The goal of the revalidation is to meet the recommendations presented in the Anvisa report.

Protection against variants

The SpiN-TEC consists in the fusion of two proteins, S and N, resulting in a “chimeric” protein. This association makes SpiN-TEC stand out from among other vaccines that include only the S protein, as this is where most viral mutations take place. As a result, neutralizing antibodies may have their efficacy diminished. Protein N is less subject to the mutations that generate new variants. SpiN-TEC can therefore offer protection against coronavirus variants.

“This vaccine was designed to result in the production of antibodies and to work on a cellular level as well, inducing the response of T lymph cells, which have immunological functions of antiviral responses. Therefore, even if the virus suffers some specific mutations, defense cells would still recognize the invading agent”, explains Gazzinelli.

In addition to generating this immune response for different variants, another positive point of the SpiN-TEC is that its technological platform has logistic advantages as well. According to the researcher, this is a highly stable vaccine that can be stored at room temperature for two weeks, and for up to six months in a fridge at 4 degrees Celsius. “This makes its distribution a lot easier, especially when we consider Brazil’s huge territory and the fact that we have towns and villages with poor infrastructure”, he says.

National production

Another important feature of the SpiN-TEC is the possibility of being entirely developed by Brazilian institutions. The Active Pharmaceutical Ingredient (API), a consumable that carries the information that makes the body prepare its defenses against the virus, was conceived and elaborated in Brazil, making the country less dependent on foreign technologies. “The chimeric protein is a recombinant protein produced in bacteria - a classic, cheap model that uses infrastructure already existing in the country”, says Gazzinelli.

According to the researcher, the clinical batch, which will be applied on the 432 volunteers during phases I and II, is ready. After the development of the API production process at CT-Vacinas (Fiocruz/UFMG), the ingredient was transferred to the University of Nebraska, in the United States, where the batch was then manufactured. Bottling was put in charge of the Cristália Industrial Pharmaceutical Complex, in São Paulo. For Phase III, which will involve about 4,000 volunteers, a partnership has already been signed with the Ezequiel Dias Foundation (Funed), the central laboratory of the state of Minas Gerais, which will be in charge of manufacturing the API. Bottling will be made by a Brazilian private company, which has already shown interest in selling the SpiN-TEC if all phases are successful.

“Brazil is a country with a tradition in research, but there is a bottleneck in the transition from a study developed by a university or research institution, such as Fiocruz, to the clinical trial, which is subject to production. We are managing to overcome this. If everything works, we’ll have a vaccine that was started from scratch all the way to its production, entirely developed in the country, getting to the arms of the Brazilian population”, says Gazzinelli.

In addition to the researchers from Fiocruz Minas and UFMG, the research also involves scientists from the Fiocruz Clinical Research Network, from the Medical School of Ribeirão Preto, from the University of São Paulo (USP), and from the Ezequiel Dias Foundation (Funed). The work has the support of the Virus Network of the Ministry of Science, Technology and Innovations (MCTI), of the City Government of Belo Horizonte, of the Legislative Assembly of Minas Gerais (ALMG), and of the Foundation of Support to Research of the State of Minas Gerais (Fapemig), in addition to the Foundation of Support to Research of the State of São Paulo (Fapesp).