Safety and Immunogenicity of a Chimeric Recombinant Covid19 Vaccine SpiN-Tec MCTI UFMG

Summary

SpiN-Tec MCTI UFMG will be used as a vaccine booster against COVID-19 and will be evaluated using the active comparator, a vaccine approved by ANVISA (Brazilian Health Regulatory Agency). The study will consist of two parts: Part A) a Phase 1 dose-escalation clinical trial to assess safety and reactogenicity; followed by Part B) a Phase 2 clinical trial to assess the safety and immunogenicity of SpiN-Tec. The study will include healthy participants of both sexes, aged 18 to 85, who have already received the full COVID-19 vaccination schedule with CoronaVac® (Butantan) or Covishield® (AstraZeneca) and who have received one or two booster doses of Covishield® or Comirnaty® (Pfizer's RNA-based vaccine) at least 6 months ago. Participants may or may not have had natural SARS-CoV-2 infection.

Timeline

Start

2022-11-23

Primary completion

2023-05-22

Completion

2025-05-07

Publications

• Background Hojo-Souza NS, de Castro JT, Rivelli GG, Azevedo PO, Oliveira ER, Faustino LP, Salazar N, Bagno FF, Carvalho AF, Rattis B, Lourenco KL, Gomes IP, Assis BRD, Piccin M, Fonseca FG, Durigon E, Silva JS, de Souza RP, Goulart GAC, Santiago H, Fernandes APS, Teixeira SR, Gazzinelli RT. SpiN-Tec: A T cell-based recombinant vaccine that is safe, immunogenic, and shows high efficacy in experimental models challenged with SARS-CoV-2 variants of concern. Vaccine. 2024 Dec 2;42(26):126394. doi: 10.1016/j.vaccine.2024.126394. Epub 2024 Oct 4.

Drugs

Indications