Partnering with researchers world-wide, DZS is on the forefront of disease eradication
By Kathryn E. Vinson, MS, CCRC, and Siza Mphele
Here at DZS, we have been honored to collaborate worldwide in vaccine trials against numerous infectious agents. This global experience puts us in a unique position of not only having worked with a multitude of national and international regulatory agencies, but also having gained experience in recruiting culturally and ethnically diverse participants, as well as protected populations such as pediatric patients.
Despite the fact that many clinical sites for vaccine research (both for COVID-19 and other infectious diseases) are located around the world, and often in difficult to reach locations, DZS Clinical Services is prepared for the challenges of executing effective monitoring plans utilizing remote monitoring systems. Starting with developing protocols and eCRFs designed with primarily remote monitoring in mind, our seasoned team of project managers, monitors, and medical writers can provide top notch oversight of vaccine trials, regardless of geographical limitations.
One such partner, LT Clinical Research and their Managing Director, Siza Mphele has shared with us invaluable insights into the conduct of clinical trials in Africa.
With a population of 1.3 billion people, Africa is poised to make a great contribution to the global effort to test new vaccines. It is important that vaccines be tested in Africa to see how they perform on the local population, as certain drugs have been shown to varying effects in certain genetic environments. It is reported that a quarter of all vaccines for diseases (other than COVID-19) are used in Africa. In line with these key facts, many sub-Saharan African countries have developed clinical trial capabilities with over 200 clinical trial sites.
Like the rest of the world, Africa is sadly not immune to misinformation about vaccine trials. The CEO of the GAVI vaccine alliance reportedly informed an African Union vaccine conference recently that the anti-vaccine sentiment in Africa is “the worst he’d ever seen.”
Despite these gloomy anti-vaccine sentiments, Africa stands shoulder to shoulder with other geographical locations to be considered a global destination for vaccine trials beyond the usual studies for HIV, TB, Malaria, and Ebola. Efforts are also underway to pitch the mother continent as the preferred destination for vaccine trials targeted at orphan diseases and pediatrics. Most of these vaccine trials were mainly Phase I and III studies conducted in adults. The most researched diseases were malaria, HIV/AIDS, tuberculosis, and Ebola virus.
An exciting development was the recent launch of the Consortium for COVID-19 Vaccine Clinical Trial (CONCVACT) by the Africa CDC. The aim of this consortium is to galvanize Africa as a premier destination for the conduct of trials not only for COVID-19 prevention, but other infectious agents such as TB, Malaria, and HIV/AIDS.
The staggering number of infections on the African continent due to many of these diseases is sobering; however, the numbers allow for tremendous pool of potential volunteers.
- Malaria – 213 million cases
- Tuberculosis – 1.4 million cases
- HIV – 20% of all global cases in South Africa alone (per UNAIDS 2020 data)
Africa’s first participation in a large-scale COVID-19 trial, focused on a vaccine developed at the University of Oxford in Britain. The South African site was initiated in June 2020. Yet another vaccine trial from a US biotech group is set to launch soon. South Africa has over 650,000 confirmed coronavirus cases, the most on the African continent, with more than 1 million cases in the continent as a whole. South Africa is fifth in global rankings for countries with the most COVID-19 cases.
Prof. John Nkengasong of the Africa Centers for Diseases Control and Prevention (Africa CDC) said in a statement that “Africa CDC will continue to work very closely with the World Health Organization to ensure that only ethically and scientifically sound clinical trials for vaccines and therapies will be conducted in Africa, using exactly the same standards and principles as those employed elsewhere in the world.”