OCT Clinical, a European CRO, has successfully completed the enrollment of 3,000 patients in a COVID-19 vaccine study. Initially, 2,000 out of 10,000 healthy volunteers were due to be given to the OCT Clinical team. However, after the recruitment of the first 2,000 volunteers across 10 sites was carried out in less than a month's time, the Sponsor increased their quota to 3,000. It took approximately 2 weeks to recruit an additional 1,000 in total (excluding time required for the delivery of additional drugs and materials).
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial, which aims to evaluate the efficacy, safety, and immunogenicity of the ReCOV vaccine. Patients are healthy volunteers aged 18 years and older who have not been previously vaccinated against COVID-19 and have not been infected with COVID-19 in the past six months.
While the overall enrollment target for this study is 10,000 healthy volunteers, OCT Clinical is responsible for enrolling 3,000 subjects. The recruitment time was successfully accelerated because there were strong relationships between those involved, and they formed part of an established network of investigative sites which had an impressive recruitment base of volunteers without coronavirus antibodies.
'We are glad with the results that the OCT Clinical team has been demonstrating. We have been impressed with the speed and quality with which they achieved our recruitment goals.' - Zhang Jianhui, Chief Medical Officer, Jiangsu Recbio Technology Co., Ltd.
Our next crucial milestone would be to prepare database for interim analysis and perform unprecedentedly fast data verification for more than 13,000 subject visits within one month, so the Sponsor could register its drug in the near future.
Within this project, the OCT Clinical team is responsible for a wide range of activities, including regulatory and logistics support, project management, volunteer recruitment and monitoring.
About Recbio
Recbio is an innovative vaccine company founded in 2012. With the vision of 'Become the Leader of Innovative Vaccines 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 a novel adjuvants platform, a protein engineering platform, and an immunological evaluation platform. Recbio has a high-value vaccine portfolio consisting of vaccine candidates for HPV, COVID-19, shingles, influenza, and adult vaccine candidates for TB. The core scientific team has more than 20 years' experience in the development and commercialization of innovative vaccines. For more information, please, visit https://www.recbio.cn/.
About OCT Clinical
OCT Clinical is one of the leading CROs, with clinical operations in Central and Eastern Europe and the CIS region. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration on time and within budget. The CRO delivers both standalone services such as medical writing, consultancy, project management, monitoring, data management, biostatistics and turnkey service for clinical development.
Learn more at www.OCT-ClinicalTrials.com.
