Brazilian health authorities on Monday approved a clinical trial for the first Covid-19 vaccine developed in the country, officials said.
The National Health Inspectorate (Anvisa) announced Monday that it had approved a clinical trial of SpiN-Tec.
SpiN-Tec is a recombinant chimeric protein developed by the Center for Vaccine Research and Production at the Federal University of Minas Gerais in southeastern Brazil.
For approval, Anvisa analyzed data from earlier phases, including nonclinical in vitro and animal studies, and preliminary data from clinical trials. Results to date have shown an acceptable safety profile for the vaccine candidate.
According to Anvisa, the SpiN-Tec trial is conducted in humans for the first time and consists of two phases.
One is “a Phase 1 dose-escalation clinical trial to evaluate the safety and reactogenicity of the investigational product, and the other is to evaluate the safety and immunogenicity of SpiN-Tec.”
In addition, the clinical trial will include healthy participants of both sexes, aged 18-85 years, who have completed initial vaccination with Coronavac or Covishield (Astrazeneca/Oxford) and who have received one or two booster doses of Covishield or Comirnaty (Pfizer) for at least six months, Anvisa said.
The Federal University of Minas Gerais funds the study, the Ministry of Science, Technology, and Innovation (MCTI), the Oswaldo Cruz Foundation (Fiocruz), and the City of Belo Horizonte, the regional capital of Minas Gerais, Brazil.