A new vaccine against covid-19 developed by laboratories in the United States and India, in partnership with Senai Cimatec (National Service for Industrial Learning) of Bahia, obtained authorization for tests on humans by Anvisa (National Health Surveillance Agency) on Thursday -Monday (26).
The study is a phase 1 and will be carried out with 90 healthy adult volunteers, aged between 18 and 55 years. The work will be conducted at the Hospital da Bahia, in Salvador.
This is the 13th clinical trial of an anticovid vaccine authorized in Brazil by Anvisa.
In the United States, another 78 volunteers will participate in this test phase, which checks the safety and dose regimen.
“The vaccine will be evaluated on a schedule of a single dose and two doses at different intervals. The first group will receive two doses with an interval of 29 days. The second group will receive two doses with an interval of 57 days. The third group of volunteers will receive one single dose of the vaccine. Three dose levels will be evaluated (1 μg, 5 μg or 25 μg) in the approved clinical trial, “adds the regulatory agency in a note.
The vaccine is based on a self-amplifying replicon RNA (repRNA) technology capable of encoding the covid-19-causing coronavirus spike protein.
Inducing an immune response to this protein is the target of most anti-covid vaccines, as the spike is responsible for binding the virus to receptors on human cells.
The vaccine project is by the North American company HDT Bio Corp. from the Indian Gennova Biopharmaceuticals and is supported by the Brazilian MCTI (Ministry of Science and Technology), through Senai Cimatec in Bahia.