The Federal University of Minas Gerais (UFMG) has opened a registration for those who wish to participate, as a volunteer, in phases 1 and 2 of the clinical trials of its vaccine against covid-19. One form online was made available today (17) to interested parties.
The expectation is that the immunizer will be available for application in the population from 2025. It is being developed at the Vaccine Technology Center (CT-Vacinas), a biotechnology center installed in the Belo Horizonte Technological Park (BH-Tec) and the result of a partnership between UFMG and the René Rachou Institute, a regional unit of the Oswaldo Cruz Foundation (Fiocruz), a scientific institution linked to the Ministry of Health.
Volunteer registrations will undergo a screening that will verify the prerequisites. Candidates for phase 1 need to be between 18 and 85 years old, be healthy, have not had covid-19, have received the initial two doses of the CoronaVac vaccine and a booster dose of Pfizer at least nine months ago.
They must also reside in Belo Horizonte during the 12 months of study and, in the case of women, not be pregnant or breastfeeding. For phase 2, the fact of having already contracted the disease will not be an impediment, but the other recruitment criteria are maintained.
The beginning of the tests has already been approved by the CEP/Conep system, the highest instance of ethical evaluation in research protocols with human beings. Initially, the studies involved small groups of healthy adults. 72 volunteers will be selected for phase 1 and 360 for phase 2. If the results are satisfactory, phase 3 will be carried out to evaluate the effectiveness with 4 thousand to 5 thousand participants.
In pre-clinical tests with animals, the results have been promising. When inoculated into mice, an adequate response was observed: the formulation induced 100% protection. Tests of tolerability and immunogenicity in non-human primates were also performed. These experiments seek to detect possible side effects and confirm the generation of antibodies.