Clinical research organisation (CRO) Emmes has announced plans to offer data, statistical analysis and project management support for a clinical trial of Moderna ’s mRNA Covid-19 vaccine in sub-Saharan Africa.
The clinical trial will enrol nearly 15,600 subjects at over 50 sites in South and East Africa.
It is intended to better understand infection and disease in immunocompromised people to prevent severe and chronic Covid-19 infections as well as reduce transmission risk.
Furthermore, the trial will analyse the vaccine’s resistance to the SARS-COV-2 variants seen in South Africa and neighbouring countries.
Assessing vaccine efficacy in human immunodeficiency virus (HIV) patients, including the influence of the previous infection and degree of immunocompromise, is the key focus of the trial.
To carry out this study, Emmes has collaborated with the COVID-19 Prevention Network (CoVPN), with operations based at Fred Hutchinson Cancer Center in the US.
Under the contract, which will conclude in September 2024, Emmes will offer the database, data management services, statistical assistance, project management coordination and central safety monitoring support for the trial.
Anticipated to last nearly 27 months, the trial comprises subject enrolment, inoculation and follow-up.
The CRO will then carry out data and statistical assessment to determine the relative risks of Covid-19 and severe disease.
The findings from the trial will permit the use of Covid-19 mRNA vaccines in an expedited manner in South Africa and other nations where variants are spreading.
Emmes CEO Dr Christine Dingivan 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.”