Synexus exceeded recruitment target in rotavirus vaccine trial in South Africa

UK-based Synexus recruited in excess of 2000 children aged between five and ten weeks of age over the course of three months, making Synexus the largest single source of subjects for a Phase III trial that investigated a paediatric vaccine against rotavirus and involved more than 3167 children across South Africa.

Rotavirus kills more than half a million children each year, the majority of whom are in the developing world, and although vaccines have already been licensed for use in many Western countries, they are not yet available in parts of Africa where they are needed most.

The aim of the trial in South Africa was to evaluate the efficacy of the vaccine in the developing world and to assist with WHO prequalification of the rotavirus vaccine for use in Africa.

The chief executive of Synexus, Michael Fort, said: ‘Our knowledge and understanding of the local culture, together with our outreach campaigns and trial sites adjacent to satellite primary health care clinics, meant that we were able to recruit well beyond our target in a matter of months. The outreach campaigns are designed to target those people who might not otherwise have access to regular healthcare, or information about the benefit of joining a clinical trial. Local healthcare professionals, with expert knowledge and training, work with our own staff to help with recruitment and managing the trial. The satellite clinics work well for those people who cannot necessarily travel to clinical trial sites, but who are within reach of their community hospital.’

Following the success of this and other rotavirus vaccine trials in the developing world, the WHO Strategic Advisory Group of Experts (SAGE) recommended the global use of vaccinations against rotavirus in a statement issued in June this year.

‘This WHO recommendation clears the way for vaccines that will protect children in the developing world from one of the most deadly diseases they face,’ said Dr Tachi Yamada, President of the Global Health Programme at the Bill and Melinda Gates Foundation (‘Global use of rotavirus vaccines recommended’, World Health Organization press release, 5 June 2009).

Rotavirus is the single most important cause of diarrhoea and is responsible for 20% to 25% of all deaths caused by diarrhoea and 6% of all deaths of children less than five years old. Effective medical care results in only 20 to 40 child deaths caused by rotavirus in the US, whereas in Africa, the figures are between 10 000 and 15 000 in children under five. In Africa and Asia alone, a rotavirus vaccine with 60% efficacy has the potential to save more than 1.5 million lives between 2010 and 2025.

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