Jiangsu Recbio Technology Co., Ltd., an innovative vaccine company, announced that the company has received approval from the Ministry of Health and Prevention of the United Arab Emirates (UAE) (Clinical Trial Approval) to conduct a phase II/III clinical study of sequential booster vaccination for its recombinant protein Covid-19 vaccine ReCOV (ReCOV) to evaluate the immunogenicity and safety of ReCOV as a heterologous booster in adult subjects.
This clinical trial is a multi-centre, randomized, observer-blinded, active-controlled phase II/III study on persons who have previously completed two doses of inactivated Covid-19 vaccine for primary vaccination and whose last vaccination is 3 to 12 months away from heterologous booster of ReCOV. It is expected that approximately 1,950 adult subjects will be enrolled.
The study's safety and immunogenicity data are expected to be published in 2022, supporting the submission to the UAE Emergency Use Authorization (EUA) for ReCOV as a heterologous booster.
In May 2020, Recbio, together with Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu CDC) and Taizhou Medical New & High-tech Industrial Development Zone, jointly developed a recombinant two-component Covid-19 vaccine(ReCOV). Under the guidance of Professor Fengcai Zhu from the Jiangsu CDC, the R&D team thoroughly optimized the vaccine using protein engineering and new adjuvant technologies, so that ReCOV has promising safety and strong immunogenicity against SARS-CoV-2 and variants of concern such as Omicorn and Delta. A series of comprehensive advantages such as better cross-protection against emerging variants, easy scale-up of production, cost advantages, worldwide accessibility, good preparation stability, and storage and transportation at room temperature which become a very competitive second-generation new Covid-19 vaccine.
Founded in 2012, Recbio is an innovative vaccine company. With the vision of "Become the Leader of Innovative Vaccine in the Future," Recbio takes "Protect Human Health with Best-in-Class Vaccines" as its mission. It has established three major cutting-edge technology platforms including novel adjuvants platform, protein engineering platform, immunological evaluation platform and mRNA vaccine platform.
