Bahia vaccine: Anvisa authorizes clinical trials with immunizing agents in Salvador

There will be a baina vaccine, yes! The Federal Government announced that Anvisa authorized, this Thursday (26), the carrying out of a clinical trial in Brazil with another candidate for the vaccine against covid-19. It is RNA MCTI CIMATEC HDT, from the US laboratory HDT Bio Corp, in partnership with the National Service for Industrial Learning (Senai Cimatec), from Bahia, and the company Gennova Biopharmaceuticals Ltd. (India). The studies will take place at the Hospital da Bahia, in Salvador.

The vaccine is based on self-amplifying replicon RNA (repRNA) technology (capable of encoding the Spike (S) protein of the new coronavirus). The pre-clinical and clinical development of the vaccine is part of a global plan being carried out in three countries: the United States, Brazil and India.

In Brazil, the partnership has the support of the Ministry of Science and Technology (MCTI). The agreement provides for the transfer of knowledge and vaccine technology to Brazil, via Senai Cimatec.

About the vaccine

The authorized clinical trial is a Phase I, Randomized, Double-Blind, Dose Escalation to Assess the Safety, Reatogenicity, and Immunogenicity of Self-Replicating Replicon RNA-Carrier Nanoparticle (repRNA) Self-Replicating Vaccine in Adults.

The vaccine will be evaluated on a single dose schedule and two doses at different intervals. The first group will receive two doses 29 days apart. The second group will receive two doses with an interval of 57 days. The third group of volunteers will receive a single dose of the vaccine. Three dose levels (1 μg, 5 μg or 25 μg) will be evaluated in the approved clinical trial.

The study protocol provides for the participation of 90 healthy adults, composed of female and male participants, aged between 18 and 55 years. In Brazil, the clinical trial will be carried out only at the Hospital da Bahia, in Salvador.

The Phase I clinical trial in the United States received FDA approval in July 2021, with the study scheduled to start in August 2021, with the participation of 78 volunteers.

HDT Bio Corp (Seattle, United States) is a biotechnology company dedicated to the development and supply of immunotherapies to people around the world, and the holder of the new candidate vaccine technology.