EPI-MAL-002: A prospective study

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: Seth Owusu-Agyei, Kwaku Poku Asante, Abena Konadu Yawson and Kaali Seyram.
Project start date: September, 2014 Project end date: October, 2019

The RTS,S/AS01E vaccine will be implemented only in malaria endemic countries of Sub Sahara Africa. Most of these countries have no baseline incidence data on rare diseases such as those that may be reported as Adverse Event following vaccination. Lack of baseline data would compromise the interpretation of any Adverse Event detected following the implementation of the RTS,S/AS01E vaccine in the paediatric population.

GSK Biologicals has developed a set of studies to address this paucity of data, and to ensure optimal collection of information related to the occurrence of those events before and after implementation of the RTS,S/AS01Evaccine.EPI-MAL-002, a pre- licensure study (i.e. before vaccine implementation), is intended primarily as a surveillance study to collect background incidence rates of protocol-defined events of special interest, other events leading to hospitalisation or death, and meningitis cases in preparation for EPI-MAL-003 (the post licensure study).

The aim of this study is to estimate the incidence of protocol-defined Adverse Event of Specific Interest (AESI) in a setting without existing surveillance systems designed to capture those rare events. The study also aims to estimate the incidence of other Adverse Events leading to hospitalisation or death, meningitis and malaria morbidity and mortality at the same time.

Approximately 40,000 children will be recruited within the collaborating study sites, and enrolled into active surveillance. These children will be actively followed up through home visits and through continuous monitoring of outpatient visits and hospitalisations at all health care facilities in the study areas. Among the 40,000 children, approximately20, 000 children will be enrolled in the 6-12 weeks group and approximately 20,000 children will be enrolled in the 5-17 months group. Kintampo site will recruit a total number of 6458, 5900 for the active group and 558 for the enhanced surveillance group.

The study is at the preparatory stage. Ethical approvals have been obtained. The key staff have been identified and training is ongoing. Logistics had been acquired. The community sensitization is also ongoing.  The study would start in February 2016.

Funder(s): GlaxoSmithKline Biologicals S.A.