NIFTY study on yellow fever vaccine dosing will improve epidemic preparedness
The EDCTP-funded NIFTY study, led by Professor Philip Bejon (University of Oxford, UK, and KEMRI-Wellcome Trust research Programme, Kilifi, Kenya), held its kick-off meeting in Kilifi from 02-03 August 2018. The NIFTY consortium prepares for a ‘Non-Inferiority of Fractional Doses Trial for Yellow Fever Vaccine’ (NIFTY). Providing evidence that a fractional dose of the vaccine may be no less effective than the currently recommended dose, would contribute to greater epidemic preparedness.
“EDCTP is pleased to contribute to this research & development effort to improve our readiness to prevent yellow fever epidemics in sub-Saharan Africa. This is a very important study that will contribute to building critically needed evidence for fractional dosing of yellow fever vaccine.”
Dr Michael Makanga, EDCTP Executive Director
“The partnership of KEMRI-Wellcome, Uganda Virus Research Institute, Epicentre in Mbarara and the Institut Pasteur in Dakar, Senegal brings together the skills in vaccine manufacture, antibody testing and clinical trials work from across the continent to deal with the yellow fever vaccine supply problem through fractional doses.”
Prof. Philip Bejon, University of Oxford, UK, and KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Yellow Fever virus is endemic in 34 countries in Africa, causing at least 130,000 symptomatic cases and 80,000 deaths in Africa every year. Life-long immunity can be conferred by a single dose of a highly effective vaccine. However, difficulties in supplying the vaccine have prevented reaching a point of sustainable control of the virus.
Vaccine production relies on laborious processes and the capacity to produce larger amounts in response to yellow fever outbreaks is limited. In 2015, UNICEF estimated the total country forecasts to be 64 million doses per year, that is 42% higher than the current availability of vaccines. As possible preventive action is limited, periodically there are major outbreaks for which the stockpile of vaccine doses is inadequate. Efficient use of available stock is therefore essential.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunisation recently recommended that fractional doses be considered in emergency responses to outbreaks where stock is limited. The NIFTY trial aims to provide certainty regarding non-inferiority of fractional doses in sub-Saharan Africa.
With an EDCTP grant of € 3,235,731 the NIFTY consortium – with partners from the United Kingdom, France, Kenya, Senegal, and Uganda – plans to conduct two trials. A trial in adults will compare in four arms the immunogenicity of full standard dose, 1000, 500, and 250 IU (International Units). Subsequently in children, the full standard dose will be compared with the lower non-inferior dose from the adult study.
The trials will be conducted in Kilifi (Kenya) and the Epicentre Research Centre in Mbarara (Uganda). The vaccine will be supplied by the Institut Pasteur de Dakar (Senegal) which is one of the only four manufacturers of the WHO prequalified vaccine.
Participating organisations:
– Oxford of University (United Kingdom) with its KEMRI-Wellcome Trust Research Programme in Kilifi (Kenya)
– Institut Pasteur de Dakar (Senegal)
– Uganda National Health Research Organisation, (Uganda)
– Epicentre (France) and its Research Centre in Mbarara (Uganda)
Photo credit: Kemri-Wellcome Trust Research Programme