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COVAXX COVID-19 Vaccine Announced Positive Phase 1 Study Results

February 9, 2021 • 11:10 am CST
(Precision Vaccinations News)

Dallas-based COVAXX announced positive interim Phase 1 data from its open-label COVID-19 clinical trial conducted in Taiwan. This study, which evaluated the safety, tolerability, and immunogenicity of the COVID-19 vaccine candidate UB-612, showed that the vaccine was generally well-tolerated and elicited robust antibody responses comparable to those seen in human convalescent sera.

The UB-612 vaccine induced neutralizing antibodies in 100% of the study's participants.

All subjects developed neutralizing antibodies after two doses of the vaccine. At the 100 ug dose level, anti-S1-RBD and viral neutralizing antibody responses compared favorably to responses observed in hospitalized patients who had recovered from COVID-19.

Overall, the vaccine was well-tolerated, and very few solicited and unsolicited adverse events (AEs) were observed. Minimal local or systemic AEs were observed after doses 1 and 2, with no increase in reactogenicity after the second dose. Almost all AEs were mild (Grade 1) and of <2-day duration, and no Serious AEs (SAEs) were observed.

The trial is ongoing, and all participants are being followed up to day 196.

“These results are very promising,” said Gray Heppner, M.D., FACP, FASTMH, Chief Medical Officer of COVAXX, in a press statement. ”We are encouraged by the data and are accelerating our Phase 2/3 program to deploy a safe and effective vaccine candidate to combat this pandemic.”

Medical Review by

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