The National Health Surveillance Agency (Anvisa) published today (3) the authorization to conduct a clinical trial that to haveSpiN-Tec, a vaccine candidate for covid-19, will be an investigational product. SpiN-Tec is a recombinant chimeric protein that uses the SpiN protein, developed by the Center for Research and Vaccine Production at the Federal University of Minas Gerais (CT Vacinas da UFMG).
For authorization, the agency analyzed data from earlier stages of product development, including non-clinical in vitro and animal studies, as well as preliminary data from ongoing clinical trials. The results obtained so far have demonstrated an acceptable safety profile of the candidate vaccine.
According to Anvisa, these are clinical trials in which the investigational product will be used for the first time in humans. The test to haveThere will be two parts: “A phase 1, dose-escalation clinical trial to verify the safety and reactogenicity of the investigational product; and another clinical trial, phase 2, to study the safety and immunogenicity of SpiN-Tec”.
“The clinical trial will include healthy participants of both sexes, aged between 18 and 85 years, who have completed the primary vaccination course with Coronavac or Covishield (Astrazeneca/Oxford), and who have received one or two booster doses with Covishield or Comirnaty (Pfizer) for at least six months”, informed Anvisa.
The study will be funded by UFMG, the Ministry of Science and Technology and Innovation (MCTI), the Oswaldo Cruz Foundation (Fiocruz) and the city of Belo Horizonte.
