A Phase 1/2 Randomized, Placebo-controlled (phase 1) and Active- controlled (phase 2), Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine…
On December 29, 2021, at the Ministry of Health, the National Ethics Council in Biomedical Research held a meeting to evaluate the mid-term results of the phase 2 clinical trial of the COVIVAC vaccine manufactured by IVAC. Phase 2 tested on 374 volunteers aged 18-59 years old and 60 years old or older in Vu Thu district, Thai Binh province. The COVIVAC vaccine has been shown to be satisfactory in terms of safety, well tolerated, and produces higher levels of neutralizing antibodies than the AstraZeneca emergency-licensed vaccine. These observations underpinned the conduct of a phase 3 clinical trial to confirm superior safety and immunogenicity compared with the licensed emergency use vaccine Astrazeneca. Specific information is presented below.