Anvisa authorizes clinical trial of a new vaccine for Covid-19 at UFMG

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The National Health Surveillance Agency (Anvisa) authorized, this Monday (3), the conduction of a clinical trial of the vaccine candidate against Covid-19 SpiN-Tec, developed by the Federal University of Minas Gerais (UFMG).

The SpiN-Tec vaccine, for intramuscular administration, has an initial two-dose schedule. Developed by the university’s CTVacinas, the differential is the mixture of two proteins of the new coronavirus, with the aim of improving the induced response in the body.

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While most vaccines rely only on the Spike protein, used by the virus to invade human cells, the UFMG vaccine also includes the N protein, which is more stable and less affected by the mutations of the new coronavirus.

According to UFMG, this feature expands the potential of the vaccine to combat a greater number of variants of Covid-19. “We realized the importance of this other protein, N, housed in the nucleocapsid of SARS-CoV-2, when we were developing the diagnostic kit for Covid-19 and decided to add it to the vaccine under development,” explained researcher Flávio Fonseca in a statement. .

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The vaccine has already passed the stage of pre-clinical tests, which showed positive results. According to UFMG, the immunizing agent did not cause detectable adverse side effects and demonstrated the ability to produce antibodies for both S and N proteins. The researchers also observed the induction of the cellular response, an essential component of the organism’s defense, with the T lymphocyte action.

The study will be funded by UFMG, the Ministry of Science and Technology and Innovation (MCTI), the Oswaldo Cruz Foundation (Fiocruz) and the City of Belo Horizonte.

Study

According to Anvisa, the approved phase 1/2 clinical trial will be carried out in two research centers, Faculdade de Medicina da UFMG and Hospital Felício Rocho, in Belo Horizonte, using advanced methodologies to compare efficacy.

SpiN-Tec will be used as a heterologous vaccine booster (different immunizers), evaluated in comparison with AstraZeneca, which will be the homologous or heterologous booster to the primary vaccination.

The clinical trial will consist of two parts. A phase 1 clinical trial of escalating dose to verify safety and adverse reactions of the product and a phase 2 clinical trial to study safety and ability to induce immune response in the human body.

According to Anvisa, the clinical trial will include healthy participants of both sexes, aged between 18 and 85 years, who completed the primary vaccination schedule with Coronavac or AstraZeneca, and who received one or two booster doses with AstraZeneca or Pfizer for the past year. at least 6 months.

A total of 432 volunteers will be included, 72 in the first part and 360 in the second stage. The recruitment of volunteers is the responsibility of the centers conducting the research.

Anvisa states that data from previous stages of product development were analyzed, including non-clinical laboratory studies (in vitro) and in animals, as well as preliminary data from ongoing clinical studies. The results obtained to date have demonstrated an acceptable safety profile for the vaccine candidate, according to the agency.

About clinical trials

Clinical trials are studies of a new drug or vaccine performed in humans. The clinical phase serves to validate the relationship between efficacy and safety of the product and also to validate new therapeutic indications.

Within this trial, there are three phases (I, II, III), where information on activity, functioning and safety is collected so that the product can be released to the market and used in patients along with the standard treatment of the research.

In order to carry out any clinical research involving human beings, the approval of the Research Ethics Committees (CEPs) or the National Research Ethics Committee (Conep) is mandatory.

Source: CNN Brasil

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