EPI-MAL 002 Summary 2020

November 02, 2020 | News | Reading time: 3 min

A prospective study to estimate the incidence of diseases specified as adverse events of special interest, of other adverse events leading to hospitalization or death, and of meningitis in infants and young children in Sub-Saharan Africa prior to implementation of the RTS,S/AS01E candidate vaccine.

Investigators from Kintampo – Kwaku Poku Asante, Pro Seth Owus-Agyei, Kaali Seyram, Prince Agyapong Darko and Samuel B. E. Harrison

Sponsor: GlaxoKlineSmith.

The lack of background disease incidence rates in sub-Saharan countries where the RTS,S/AS01E malaria vaccine is being implemented may hamper interpretation of vaccine safety and effectiveness. The EPI-MAL 002 study aimed to generate baseline incidence rates of meningitis, malaria, mortality, adverse events of special interest (AESI), and other events leading to hospitalization, prior to the implementation of the vaccine within the Malaria Vaccine Implementation Programme.

The ongoing disease surveillance study is combining prospective cohort event monitoring and hospital-based disease surveillance in three study sites in Ghana and Kenya. Children were enrolled into different groups; active and enhance hospitalisation group (5-17 months or 6-12 weeks age-group and enhance hospitalisation 0-60 months). In all eleven thousand nine hundred and fifty (11,950) children have been enrolled into the study. Eight thousand nine hundred (8900) children have been enrolled into the active surveillance and 3050 into enhance hospitalization cohort respectively. Out of the 11,950 enrolled, we recorded 13 AEIS, 25 suspected Cerebral Spinal Meningitis over a follow up period of 4 years.

The enrolment into active surveillance ended in March 2018 and those in the enhance hospitalization cohort ended in March 2019. The team is continuing with the active participants follow up visits till 2023 however we have exited all enhance group since April 2019