Clinical Trials of South Carolina (CTSC) has been selected by a major vaccine developer to conduct of the next phase clinical trial. The “Lowcountry” clinical investigational site didn’t share the name of the sponsor but did published that the trial centers on a vector vaccine targeting COVID-19. This independent site is targeting the recruitment of 1,500 participants for a 30,000 volunteer Phase 3 clinical trial. As TrialSite has reported, it would appear that the AstraZeneca/Oxford vector-based vaccine Phase 3 clinical trial is coming to America soon.
Local news outlet Live 5 News’ Paola Tristan Arruda reported that this South Carolina site, just one of a few in America’s southeast, will commence the study, its third round of research for the vaccine, in August. Dr. Matthew Drakeley, a pain management physician with Pain Specialists of Charleston (associated with the Clinical Trials of South Carolina), leads the study and reports to local news this big study involving up to 30,000 participants is about finding efficacy.
A “Vector Vaccine”
Dr. Drakeley reported that “This is a called a vector vaccine so its actually a different virus that is not the coronavirus that shares similar properties.” He continued, “Specifically it has similar “S” protein on the outside of the virus so when it is given to the cells in the human body, they can start recognizing and treating and building up immunity. That way, when it is faced against the coronavirus it will be able to fight off the virus effectively.” The “Oxford” vaccine is also a vector-based vaccine. Previously called ChAdOx1 nCoV-19, at least for the American market the vaccine is now known as AZD1222.
The Forthcoming AZD1222 Clinical Trial
TrialSite reported that Oxford’s Sarah Gilbert, the vaccine’s inventor, declared at a Parliamentary hearing in the UK that the clinical trial for AZD1222 has moved into Phase 3 and that 8,000 volunteers (at that time) were already enrolled. The AZD1222 Phase 3 trial is ongoing in the UK, South Africa and Brazil. There haven’t been any disclosures about the American trial. But based on a press release from the Orlando Immunology Center, TrialSite discovered that the Phase 3 AZD1222 trial was coming to America by August. The study will involve the enrollment of 30,000 participants starting in August.
The Trial Site
Clinical Trials of South Carolina (CTSC) is targeting to enroll up to 1,500 participants over an 8 week period of time. Ms. Tristan Arruda reports that the volunteer receives the vaccine on day 1 and day 28. Thereafter, the clinical investigational team will carefully monitor the study participants to review any signs for infection or side effects.
Whitney Billingsley, recruitment and program coordinator for CTSC, reports that the study is “Open to anyone who is at least 18 years old and who has never had the coronavirus before.” Ms. Billingsley emphasized the importance of high risk populations to participate including those working in health care, first responders and other “essential workers.”
An independent investigative site, CTSC touts on its website that it has been nationally and internationally recognized for high enrollment and quality data. The Lowcountry site has participated in clinical trials spanning pain management to Ulcerative Colitis, GERD/Acid Reflux, Irritable Bowel Syndrome (IBS), Myasthenia Gravis and of course COVID-19. The research site operation maintains three locations, including two in the Lowcountry and one site in Columbia, South Carolina. The organization was founded by Edward M. Tavel Jr., MD, in 2019. Dr. Tavel earned his MD from Medical University of South Carolina (MUSC) with Residency and Fellowship from University of North Carolina, Chapel Hill. Dr. Tavel also owns Pain Specialists of Charleston.