A clinical trial due to launch in the Democratic Republic of Congo (DRC) and other countries in Africa will assess whether an mpox vaccine can protect people against the disease after they have come into contact with the potentially deadly infection.
The ‘SMART’* trial (#NCT05745987) has received US $4.9 million from CEPI and the Canadian Institutes of Health Research to find out if post-exposure vaccination of Bavarian Nordic’s MVA-BN® mpox vaccine could reduce the risk of secondary mpox cases, or, if a person contracts mpox, could reduce their severity of illness. The announcement comes on the launch of the Global Pandemic Preparedness Summit 2024, co-hosted by CEPI and partners, in Rio de Janeiro, Brazil, 29-30 July.
The evidence generated could be crucial in shaping mpox vaccination strategies to help tackle a large and deadly mpox outbreak escalating in the DRC and neighbouring countries. Over 11,000 cases and 443 deaths have been reported in the DRC so far this year, with children accounting for the majority of infections and deaths.
Led by Mark Loeb, a Professor of Pathology and Molecular Medicine with Canada’s McMaster University, the research will invite over 1500 participants (aged over 10) in households with a laboratory-confirmed mpox infection at sites in the DRC, Uganda and Nigeria to take part in the trial. The study is due to launch next month in the DRC, enrolling participants from Kamituga, South Kivu province, an area which has recently reported mpox cases.
Four weeks after participants are randomly allocated to receive either a single dose of MVA-BN or a control vaccine, scientists will compare the number of participants who contract mpox in each group. If anybody becomes sick, the researchers will conduct follow-up assessments measuring the severity of their symptoms. For example, they will look at whether a participant who received the MVA-BN® vaccine develops fewer skin lesions than the control group and the time taken for these lesions to heal, while also monitoring hospitalisation and mortality records.
