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test the safety and efficacy of this new formulation in young children

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Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

The challenge

Vaccines hold great promise for controlling and eliminating infectious diseases in sub-Saharan Africa. However, vaccines often perform less well in Africa than in high-income countries, emphasising the importance of vaccine studies in African populations.

Realising the full potential of vaccines will therefore depend on the strengthening of vaccine research capacity in Africa. In addition, it is important to understand the reasons underlying the lower efficacy on vaccines in Africa. As more trials are undertaken in sub-Saharan Africa, there is also an increasing need to develop social science expertise to ensure effective community engagement.

Dr Selidji Agnandji has been involved in key clinical trials of vaccines in sub-Saharan Africa. These include influential trials of the most advanced malaria vaccine (RTS,S/AS01) and Ebola vaccine (rVSV-ZEBOV).

In his EDCTP Senior Fellowship, Dr Agnandji aims to strengthen vaccine research in the Centre of Medical Research Lamberéné (CERMEL) in Gabon. In the area of biomedical research, he will carry out a systematic review of studies of immune responses to vaccination in sub-Saharan Africa, India, Europe and North America, to determine whether lower performance is specific to certain vaccines or a common phenomenon. In laboratory studies, he will explore whether immune responses before, during and after vaccination with an experimental malaria and Ebola vaccine influence the kinetics of vaccine-induced responses. He will assess whether Ebola vaccination affects responses to currently used vaccines.

In the social science element of his fellowship, Dr Agnandji will examine how well the biomedical sciences are integrated in sub-Saharan African societies. He will also develop a novel framework to better capture the social and economic impacts of biomedical research in sub-Saharan Africa.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

Dr Agnandji’s Senior Fellowship project will provide additional information on immune responses to vaccination in sub-Saharan Africa populations, data that will inform the design of vaccines that are more effective in this setting. He will also strengthen social science research in the region, of growing importance as more vaccines become available for testing.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact