IVM-KIDS

The challenge

Ivermectin is one of the world’s most widely used antiparasitic drugs. It is active against a wide range of parasites that cause neglected tropical diseases, including onchocerciasis, lymphatic filariasis and some soil-transmitted helminth infections. Collectively, these diseases affect more than a billion people, most of them in sub-Saharan Africa. 

Ivermectin is commonly used in mass drug administration campaigns. It can be used on its own, but there is also growing evidence of the additional benefits of combination drug use alongside albendazole, which is also active against soil-transmitted helminths.

However, unlike albendazole, ivermectin is not approved for use in children less than 5 years old or weighing less than 15 kg. This is partly because of limited safety data in this age group and partly because of the risk of choking on currently used tablets.

Theoretical safety concerns arose because of fears that the immaturity of the blood–brain barrier in young children might allow ivermectin to cross into the brain. However, recent research suggests that the key protein preventing ivermectin access to the brain in adults is also present in young children. In addition, when young children have been exposed to ivermectin, no safety issues have arisen.

The project

The IVM-KIDS project is developing a dispersible ivermectin tablet for young children and undertaking a range of studies to demonstrate its safety and efficacy.

The largest study of the project, planned for Ghana, Kenya, the Democratic Republic of the Congo (DRC) and Tanzania, is designed to demonstrate the safety of the new tablet when given alongside albendazole. Around 4,500 children weighing 5–15 kg will be recruited to this study.

A sub-study involving 1,200 children will test the efficacy of the new ivermectin tablet, focusing on Trichuris trichiura (whipworm) infections, which are only partially susceptible to albendazole. Finally, a pharmacokinetic study in 400 children will assess circulating drug levels to ensure that dosing is appropriate. 

Alongside these studies, consultations will be carried out with children and caregivers to assess the palatability and acceptability of the new formulation. 

Impact

The IVM-KIDS project will expand access to a key antiparasitic drug. It will:

• Develop an ivermectin tablet suitable for young children that dissolves in the mouth (orodispersible).
• Confirm that the new tablet is safe, efficacious and acceptable to children and caregivers.
• Generate the evidence required to support licensing applications. 

Ultimately, the IVM-KIDS project could enable millions of children under 5 years of age to gain access to ivermectin, preventing parasite infections that can have a major impact on physical and cognitive development, and are associated with neurological complications, including epilepsy, in sub-Saharan Africa.