The vaccine against Covid-19, RNA MCTI CIMATEC HDT, produced by the company HDT Bio Corp, from the United States, will enter the first phase of testing, in September, and the study will be conducted by Senai Cimatec, in Salvador.
According to information from Senai Cimatec, the repRNA (RNA replicon) vaccine is the first immunizing agent that uses this technology to have this phase carried out in Brazil. The clinical development stage will cost R$ 6 million.
Depending on the institution, the RNA replicon is able to self-amplify and be recognized by the organism as a messenger RNA.
According to Senai, with this, the RNA replicon teaches the human body to produce responses against the virus (antibodies). The forecast is that 90 volunteers, aged between 18 and 55 years, will participate in this phase.
The immunizing agent is developed by HDT Bio Corp (Seattle, USA), a non-profit biotechnology company. The vaccine is part of a global development plan, which is being carried out in the Brazil, USA and India, through a partnership between three institutions: Senai Cimatec, HDT Bio Corp and Gennova Biopharmaceuticals (India).
In Brazil, the development of the immunizing agent has the scientific support of the Ministry of Science, Technology and Innovation (MCTI). At Cimatec, the project is under the responsibility of the Senai Institute for Innovation in Advanced Health Systems.
According to the infectious disease physician and professor at Senai Cimatec, Roberto Badaró, the main objective of this step is to assess the ability of the vaccine to generate local or systemic adverse reaction (or collateral) in the body.
“Three different dose concentrations will be tested, verifying which one will be more promising in the production of humoral and cellular immune response against the SARS-CoV-2 virus”, he explained.
Salvador will have the first phase of testing a new vaccine against Covid-19 — Photo: Cimatec Archive
The vaccine uses third-generation RNA technology: an RNA replicon molecule, which, in contact with the body, has the ability to self-reproduce, then generating messenger RNA, which teaches the human body to produce antibodies.
According to Senai Cimatec, it is a vaccine with great possibility of being applied in a single dose and capable of promoting a robust and lasting response, including against the different strains of the virus.
Studies of the new vaccine candidate for Covid-19 also include phases II and III, until the immunizing agent is approved for registration and production in Brazil.
If safety in the first step is proven, statistical analysis of the data will be performed, and phase II will start, with the participation of 400 individuals.
Likewise, the start of phase III will depend on the results of the previous phase. For phase III, the recruitment of 3,000 to 5,000 participants is planned.. In all, the testing period will last about a year.
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