Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it is providing data, statistical analysis, and project management support for new research that will test the Moderna mRNA vaccine at more than 50 sites in South and East Africa.
The clinical trial, which will include about 15,600 participants, seeks to better understand infection and disease in immunocompromised populations in order to prevent severe COVID-19 and chronic SARS-CoV-2 infections and minimize the risk of transmission. The study will also address the COVID-19 mRNA vaccine’s resistance to the variants that have been detected in South Africa and surrounding countries.
An important focus of the study is to evaluate vaccine efficacy among people living with HIV, including the influence of prior infection and the degree to which they are immunocompromised.
Emmes has partnered with the COVID-19 Prevention Network (VPN), with operations based at Fred Hutchinson Cancer Center, to conduct this research. Fred Hutch is the CoVPN operations center for vaccine studies and has conducted numerous HIV studies around the world in the past few decades as part of the HIV Vaccine Trials Network (HVTN). After the onset of the COVID-19 pandemic, Fred Hutch was selected as the CoVPN operations center to build upon the expertise and infrastructure of the HVTN. The National Institute of Allergy and Infectious Disease, part of the National Institutes of Health, and the Department of Health and Human Services are funding the study.
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Emmes will provide the database, data management services, statistical support, project management coordination, and central safety monitoring support. The study includes participant enrollment, vaccination, and follow-up and is expected to last about 27 months. Subsequently, Emmes will conduct the data and statistical analysis, addressing the relative risks of COVID-19 and severe COVID-19. This part of the contract will conclude in September 2024.
According to Valerie Brown, Emmes’ project leader, “It is an honor for Emmes to join the COVID-19 Prevention Network and Fred Hutchinson Cancer Center in this important research. This has far-reaching public safety implications in the global effort to control the pandemic.”
The data produced from this clinical trial will allow COVID-19 mRNA vaccines to be utilized expeditiously in South Africa and other countries where the COVID-19 variants are spreading. The research will provide access to an early and highly effective option for controlling the pandemic in these countries, prior to the availability of a vaccine tailored to the resistant strain or strains.
Dr. Christine Dingivan, Chief Executive Officer of Emmes, said, “Our earlier research support for COVID-19 therapies and vaccines has now evolved to more specific sets of patients, from those who are immunocompromised to populations across the world where variants are now spreading. Over 20 percent of Emmes’ employees have worked on COVID-related projects this past year, and we are committed to continuing our efforts to build the body of knowledge that will ultimately result in an end to this pandemic.”