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news.To evaluate the efficacy of the vaccine in the developing world
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UK-based Synexus has 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 5 and 10 weeks over the course of 3 months, making Synexus the largest single source of subjects for this Phase III trial involving over 3167 children across South Africa.
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 3 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.”
Michael Fort, chief executive, said: “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.