Dr Roma Chilengi

Zambia

EDCTP portfolio: Senior Fellowships

Dr Roma Chilengi is exploring whether an additional dose of rotavirus vaccine provides infants with additional protection against this important gastrointestinal pathogen.

Enhancing rotavirus protection in children

Diarrhoeal disease kills more children than HIV/AIDS and measles combined. Globally, diarrhoea is the second biggest killer of children, and rotavirus is the leading cause of severe diarrhoea in children under 5 years of age.

Many countries have introduced rotavirus vaccination into their national immunisation programmes, leading to a significant drop in diarrhoeal disease and hospitalisation. However, the performance of rotavirus vaccines is generally lower in low- and middle-income countries (LMICs) than in high-income countries.

The challenge

Dr Roma Chilengi returned to his home country of Zambia in 2011, having held positions in Europe and Kenya. He is head of the Centre for Infectious Disease Research in Zambia, and has worked with the Ministry of Health and NGOs on projects that have significantly cut child mortality locally, including rollout of rotavirus vaccination.

In his EDCTP Senior Fellowship, Dr Chilengi is assessing whether adding a third dose of rotavirus vaccine at nine months boosts rotavirus-specific immune responses at 1 year, providing longer-lasting protection. More than 200 mother–infant pairs are being recruited just before first vaccination and half will receive an additional dose at nine months. As well as antibody responses at 1 year, the study will monitor safety, analyse infants’ immune responses and assess the impact of diarrhoeal disease on growth rates.

The project will also contribute to research capacity building in Zambia. One PhD and one master’s student will receive training through the project. 

The project

Dr Chilengi’s Senior Fellowship project will determine whether a third dose of rotavirus vaccine compensates for the reduced effectiveness of such vaccines in LMICs – information that will be highly relevant not just to Zambia but also to other LMICs. Findings may also identify elements of the immune response indicative of protection. The project will also add to clinical research capacity at the University of Zambia.

Impact


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

Bringing antiretroviral drugs to children

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

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Diarrhoeal disease kills more children than HIV/AIDS and measles combined. Globally, diarrhoea is the second biggest killer of children, and rotavirus is the leading cause of severe diarrhoea in children under 5 years of age.

Many countries have introduced rotavirus vaccination into their national immunisation programmes, leading to a significant drop in diarrhoeal disease and hospitalisation. However, the performance of rotavirus vaccines is generally lower in low- and middle-income countries (LMICs) than in high-income countries.

Dr Roma Chilengi returned to his home country of Zambia in 2011, having held positions in Europe and Kenya. He is head of the Centre for Infectious Disease Research in Zambia, and has worked with the Ministry of Health and NGOs on projects that have significantly cut child mortality locally, including rollout of rotavirus vaccination.

In his EDCTP Senior Fellowship, Dr Chilengi is assessing whether adding a third dose of rotavirus vaccine at nine months boosts rotavirus-specific immune responses at 1 year, providing longer-lasting protection. More than 200 mother–infant pairs are being recruited just before first vaccination and half will receive an additional dose at nine months. As well as antibody responses at 1 year, the study will monitor safety, analyse infants’ immune responses and assess the impact of diarrhoeal disease on growth rates.

The project will also contribute to research capacity building in Zambia. One PhD and one master’s student will receive training through the project. 

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 Chilengi’s Senior Fellowship project will determine whether a third dose of rotavirus vaccine compensates for the reduced effectiveness of such vaccines in LMICs – information that will be highly relevant not just to Zambia but also to other LMICs. Findings may also identify elements of the immune response indicative of protection. The project will also add to clinical research capacity at the University of Zambia.

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

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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