Researchers from the Federal University of Minas Gerais (UFMG) are looking for volunteers for the clinical trials of the 100% Brazilian vaccine against Covid-19 “SpiN-TEC MCTI UFMG“.
Clinical trials are studies of a new drug or vaccine involving human subjects. The clinical phase allows evaluating aspects of efficacy, safety and ability to induce the immune response. Within this trial, there are three phases in which information is collected so that the product can be released to the market and used in patients.
To advance and reach the population, the first vaccine against the coronavirus fully developed on national soil needs ten volunteers. However, the research faces difficulties in following the experiments due to the difficulty in finding participants.
See the criteria for selecting volunteers:
- Be between 18 and 54 years old;
- having taken 2 doses of CoronaVac;
- 1 dose of Pfizer with an interval between 9 and 15 months (i.e. between October 2021 and May 2022);
- not having comorbidities;
- never having had Covid-19;
- live in Belo Horizonte
“We are in the final stretch to finalize Phase 1 recruitment. The vaccine has been shown to be safe so far: we have not had any serious adverse events. And this stage serves exactly this purpose: to observe the safety of the immunizer”, explains Helton Santiago, professor at UFMG and coordinator of the clinical trial phase.
Clinical trials are organized into three phases. SpiN-TEC MCTI UFMG is almost finalizing the first phase, when the vaccine is tested on 36 volunteers.
In each arm, as the sub-step of this phase is called, the vaccine is applied, in different amounts, to 12 volunteers. Two arms have already been successfully carried out – that is, 24 volunteers have already received the immunizer and no serious reaction has been recorded.
These volunteers will still be observed for months – in all, the volunteer is monitored by the CTVacinas and UFMG team for a year, including periodic visits to the Clinical Research Unit in Vaccines (UPqVac), installed at the UFMG Faculty of Medicine.
“We need to close this group to comply with the protocol and move forward. This phase exists in the protocol precisely to demonstrate the safety of the vaccine and allow the choice of the most rational dose”, explains Helton Santiago.
“It is the first genuinely Brazilian vaccine. Without the volunteers, we could not complete the study phase and place the vaccine on the market”, summarizes Graziella Rivelli, leader of the Regulatory Platform of CTVacinas.
To apply, just message WhatsApp 31 99972-0292.
Those interested in participating must register online, via WhatsApp (31-99902-7292) or call (31) 3401-1152. Once enrolled, volunteers will undergo screening and undergo clinical and laboratory evaluations conducted by CTVacinas and the Clinical Research Unit for Vaccines (UPqVac).
Subsequently, in phase 2, which will have 360 volunteers, the criteria will be to be between 18 and 85 years old, to be healthy, to have received the two initial doses of the Coronavac or AstraZeneca vaccine and one or two booster doses of Pfizer or AstraZeneca and to reside in Belo Horizonte during the 12 months of study.
Women cannot be pregnant or breastfeeding. The fact of having already contracted Covid-19 will not prevent the person from qualifying for the second phase of the tests.
Source: CNN Brasil
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