arlier and [they] get treatment, whereas … [other children] may not be able to get to a clinic, may be misdiagnosed or get poor treatment,” said Grey.
Consent is always a crucial issue. “You also have to make sure the parents or caregivers understand the informed-consent process, the risks and benefits, that a vaccine may or may not work, and that their child is contributing to science.”
Ethics in practice
The town of Worcester, in the winelands of Western Cape province, is one of three towns participating in the Satvi trial. HIV and TB co-infection has been the most significant cause of premature death in the province since 2007.
Tameris said the blood samples taken in this study would be much smaller, and would also be taken less often, because drawing adult-sized samples from pint-sized participants could mean risking anaemia or other illnesses.
“You have to work out the absolute minimum sample you need, down to microlitres. Babies are very sweet and cute, but it’s not always easy when they become distressed and resent having to be held tightly to have blood taken,” she said.
Blessing in disguise
The Department of Health estimates that almost 90% of children under the age of one were immunised in 2008.
“We have very high immunisation rates in South Africa so we have a culture of immunising our children and, in that sense, vaccine trials are easier and more understandable than drug trials to many people,” Grey said.
Although there have been concerns that the legally mandated R150 (US$19) given to participants per clinic visit could provide an incentive, Linda Sibeko, who lives in Worcester and is a member of the study’s interim community advisory board, said parents saw it as a way of learning more about TB.
“People are welcoming it. We explained … and now everyone wants to be involved.”
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- Source: Irin PlusNews
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