UK-based Synexus, the world's largest multi-national company dedicated to the recruitment and running of clinical trials, recruited the highest number of patients to the South African study investigating a paediatric vaccine against rotavirus.

The company recruited in excess of two thousand children aged between five and 10 weeks over the course of three months, making Synexus the largest single source of subjects for this phase-III trial involving over 3167 children across South Africa.

Rotavirus kills over half a million children each year, the vast majority in the developing world, and whilst 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 pre-qualification of the Rotavirus vaccine for use in Africa. Dr Sanet Aspinall, managing director of Synexus in South Africa was the national coordinator of a consortium of 11 sites involving three organisations, which conducted the vaccine trial there: "Ensuring we recruited subjects to this trial promptly and managed this trial as efficiently as possible was vital. There is no denying the importance of implementing a vaccination programme against rotavirus as soon as possible in countries across Africa, where large numbers of very young children are dying needlessly. We were keen to work closely with the sponsors and other bodies involved, to drive this programme forward."

Synexus have worked with sponsors on numerous late stage vaccine trials. Their wholly-owned network of Dedicated Research Centres in the UK, CEE and South Africa give them access to many millions of candidates suitable to join vaccination trials and their local knowledge is critical to ensuring recruitment is fast and reliable.

The recent Rotavirus trial in South Africa was testimony to the success of their recruitment model and their ability to reach out to local communities according to chief executive, Michael Fort: "For this trial 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. Feedback from pharma, CRO and NGO clients indicates that our model works particularly well for late stage vaccine trials."

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.

Rotavirus is the single most important cause of diarrhoea, responsible for 20 to 25 per cent of all deaths due to diarrhoea and 6 per cent of all deaths of children less than five years old. Effective medical care results in only 20 to 40 children dying each year due to Rotavirus in the US, whilst in Africa the figures are between ten and fifteen thousand in children under five. In Africa and Asia alone, a Rotavirus with sixty per cent efficacy has the potential to save more than 1.5 million lives between 2010 and 2025.