The National Sanitary Surveillance Agency (Anvisa) authorized, this second February (3), to carry out a clinical trial of a 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 schedule of two doses. Developed by CTVacinas da Universidade, or immunizing tem as a differential mixture of two proteins of the novo coronavirus, with the objective of improving the non-organism induced response.
While most of the vaccines contain only 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 broad or potential feature gives vaccine for or combat a greater number of variants of Covid-19. “We perceive the importance of another protein, N, housed in the nucleocapsid of SARS-CoV-2, when we were developing a diagnostic kit for Covid-19 and decided to add it to the vaccine in development”, explained the researcher Flávio Fonseca in a statement .
A vaccine has already passed through stage two pre-clinical tests, which presented positive results. According to UFMG, the immunizer did not cause detectable adverse side effects and demonstrated a capacity to produce antibodies both to protein S and to N. The researchers will observe, furthermore the induction of the cellular response, an essential component of the organism’s defense, with action of two T lymphocytes.
The study will be financed by UFMG, by the Ministry of Science and Technology and Innovation (MCTI), by the Oswaldo Cruz Foundation (Fiocruz) and by the Prefecture of Belo Horizonte.
study
According to Anvisa, the phase 1/2 approved clinical trial will be carried out in two research centers, UFMG School of Medicine and Felício Rocho Hospital, in Belo Horizonte, based on advanced efficacy comparison methodologies.
SpiN-Tec will be used as a heterologous vaccine booster (different immunizers), supported by comparison with AstraZeneca, which will be either a homologous or heterologous booster to primary vaccination.
The clinical trial will be composed of two parts. A phase 1 clinical trial of staggered doses to verify the safety and adverse reactions of the product and a phase 2 clinical trial to study the safety and ability to induce an immune response in the human body.
According to Anvisa, the clinical trial will include healthy participants of both sexes, aged between 18 and 85, who will complete the primary vaccination schedule with Coronavac or AstraZeneca, and who will receive one or two booster doses with AstraZeneca or Pfizer. hair less 6 months.
A total of 432 volunteers will be included, being 72 in the first part and 360 in the second stage. The recruitment of two volunteers is responsible for two centers that conduct research.
Anvisa affirms that the analyzes given in the previous stages of the development of the products were analyzed, including non-clinical studies in the laboratory (in vitro) e em animais, bem as preliminary data of clinical studies in progress. The results obtained at this time demonstrate a profile of oil insurance as a candidate for vaccination, second to the agency.
About clinical trials
The clinical trials are the studies of a new medicine or vaccine carried out in human beings. The clinical phase serves to validate the relationship of 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 is collected on activity, operation and safety so that the product can be released on the market and used in patients together with the standard research treatment.
To carry out any clinical research involving human beings, the approval of the Research Ethics Committees (CEPs) or the National Research Ethics Commission (Conep) is required.