IVI and the Democratic Republic of the Congo (D.R. Congo)
Planned in conjunction with the SETA Program (see below), THECA came into place after a consortium led by the University of Cambridge Department of Medicine received a 13-million euro grant from the European and Developing Countries Clinical Trials Partnership (EDCTP). THECA includes a mass vaccination campaign in the Democratic Republic of the Congo using the Typbar-TCV (Vi-TT) typhoid conjugate vaccine. From 2019-2023, this project will assess the safety, feasibility and cost-effectiveness of Vi-TT and its ability to limit the spread of antimicrobial resistance. In-country collaborators included the Institute National for Biomedical Research and Kisantu Hospital Saint-Luc.
The THECA project was initiated in 2019, planned in parallel to the SETA program. THECA includes a cluster-randomized vaccine effectiveness trial in Ghana and a mass vaccination campaign in DRC using the recently licensed typhoid conjugate vaccine Typbar-TCV® (also referred to as Vi-TT). An embedded health economics study will also assess the feasibility and cost-effectiveness of TCV when administered through a mass vaccination campaign. These studies will additionally generate data on the safety and immunogenicity of Vi-TT and measure the impact of vaccination in limiting the spread of antimicrobial resistance.
In D.R. Congo, the team completed a household enumeration census in 2020 in addition to ongoing clinical surveillance. The team is currently finalizing both the main vaccination study and the health economic study protocols with mass vaccination planned across the Kisantu health zone in early 2021.
In D.R. Congo, THECA works in cooperation with the Institute National for Biomedical Research, with funding from the Melinda Gates Foundation and the Second European and Developing Countries Clinical Trials Partnership Programme
Hepatitis E Epidemiology in Africa (HEVA)
In late 2020, IVI received a $500,000 grant from the Bill and Melinda Gates Foundation to conduct seroepidemiology of HEV in Africa. In 2021, IVI will form a consortium with the Institute Pasteur in Dakar, Senegal; the University of Ibadan in Ibadan, Nigeria; and the Institute Nationale de Recherche Biomédicale in Kinshasa, Democratic Republic of the Congo (DRC) to screen approximately 18,000 blood samples from 19 countries to determine the prevalence of HEV across different demographics, groups, and regions in Africa.
Severe Typhoid in Africa (SETA) and SETA Plus
After its launch in 2015, the SETA program began surveillance activities in Democratic Republic of the Congo in 2017, expanding its efforts to determine the severe disease study and economic burden of Salmonella infections in sub-Saharan Africa. This two-year project resulted in first incidence estimations of data, following which the Bill and Melinda Gates Foundation extended additional funding for typhoid surveillance in Democratic Republic of Congo and four other SETA countries. Since 2020, SETA Plus has continued the research and monitoring of typhoid in Democratic Republic of the Congo.
In 2017, IVI began conducting epidemiologic and socio-economic research on Typhoid in D.R. Congo through its Severe Typhoid in Africa (SETA) study. The Bill and Melinda Gates Foundation granted additional funding for further typhoid surveillance in D.R. Congo as a part of SETA Plus (+), an initiative intended to commence at the beginning of 2020.
From 2002 to 2005, IVI carried out its first global program, the Diseases of the Most Impoverished (DOMI) disease burden study. As part of DOMI, IVI investigated the disease burden of Shigella in Bangladesh, China, Indonesia, Pakistan, Thailand, and Vietnam. A total of 605,331 individuals were under surveillance and 56,958 episodes of diarrhea were detected, 2,927 (5%) of which were shigellosis. In Bangladesh, IVI established a study site in Dhaka. The study uncovered high Shigella incidence rates in Bangladeshi children (46 per thousand children/year) and discovered that more that 20% of isolated Shigella in Bangladesh belonged to S. boydii species, which is not commonly observed in either developed or developing countries.
The results of the Shigella study in Bangladesh have major implications for the design of new vaccines and influenced the development of IVI’s Shigella vaccine.