UAE approves Phase II/III clinical trial of ReCOV sequential booster immunization

On April 13, Jiangsu Recco Biotechnology Co.
, Ltd.
(referred to as "Recco Bio" or the "Company", stock code: 2179.
HK) announced that it has obtained Arab Clinical Trial Approval from the United Emirates National Ministry of Health and Prevention to conduct a Phase II/III clinical study of sequential boosters to evaluate the immunogenicity and safety of ReCOV as a heterologous booster in adult subjects
.
This clinical trial is a multi-center, randomized, observer-blind, positive control for people who have previously completed two doses of inactivated COVID-19 vaccine primary immunization, and the last vaccination time is 3 to 12 months from the ReCOV heterologous booster vaccination.
A Phase II/III study of 1,950 adult subjects
.
The study's safety and immunogenicity data are expected to be released in 2022, supporting the UAE Emergency Use Authorization (EUA) submission for ReCOV as a heterologous booster
.
About the recombinant two-component new coronary pneumonia vaccine ReCOV In May 2020, Ruike Biotech, together with the Jiangsu Provincial Center for Disease Control and the Taizhou Medical Park Management Committee, jointly developed the recombinant two-component new coronary pneumonia vaccine (CHO cells) (referred to as ReCOV vaccine)
.
Under the guidance of Professor Zhu Fengcai from the Jiangsu Center for Disease Control and Prevention, the R&D team has thoroughly optimized the vaccine using protein engineering, new adjuvant and other technologies, so that ReCOV has good safety, strong immunogenicity, and is very resistant to mutant strains that are currently popular in the world.
A series of comprehensive advantages, such as good cross-protection effect, easy production scale-up, low production cost, good formulation stability, and room temperature storage and transportation, have become a very competitive new generation of new crown vaccines
.