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June 1, 2021updated 12 Jul 2022 11:13am

IVI to design adaptive Phase Ib/IIa trial for schistosomiasis vaccine

The vaccine could be a safe and cost-effective option to lower morbidity and mortality from the schistosomiasis disease.

The International Vaccine Institute (IVI) has received a grant from the Bill & Melinda Gates Foundation to design an adaptive protocol for a Phase Ib/IIa clinical trial of a schistosomiasis vaccine candidate, SchistoShield (Sm-p80 adjuvanted in GLA-SE).

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In non-human primate studies, the vaccine candidate demonstrated favourable safety and efficacy.

It shows different mechanisms of action in the Schistosome lifecycle and could possibly offer a treatment that disrupts the schistosomiasis infection cycle.

A parasitic disease, schistosomiasis is caused by trematode worms of the Schistosoma genus.

The Trial Planning Grant from the Gates Foundation is part of its Design, Analyze, Communicate (DAC) programme to aid beneficiaries in streamlining clinical trials to offer informative and impactful results.

The objective of IVI’s schistosomiasis vaccine programme is to expedite the development of a vaccine that is safe, efficient and cost-effective and can lower morbidity and mortality from the disease in moderate to high-transmission areas.

IVI Epidemiology, Public Health and Impact deputy director-general Dr Florian Marks said: “A safe, effective, and accessible vaccine is the most sustainable solution to breaking the devastating cycle of Schistosomiasis infection and will save lives and improve the livelihoods of hundreds of millions of people.

“We are grateful to the Gates Foundation for their support and guidance in planning an adaptive Phase Ib/IIa clinical trial for a schistosomiasis vaccine candidate, which would accelerate the clinical development timeline as well as licensure and pre-qualification processes.”

This vaccine project also received funding from the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases and European Union’s (EU) Horizon 2020 to support Phase I trials of the SchistoShield vaccine.

A first-in-human safety study will be conducted in healthy adults in the US at an NIH Vaccine and Treatment Evaluation Unit.

Subsequently, a Phase Ib placebo-controlled trial assessing the safety and immunogenicity of the vaccine in healthy adults in Burkina Faso and Madagascar will be launched.

IVI noted that the latest grant will aid in adapting the Phase Ib trial design, which could facilitate expediting the vaccine’s clinical development.

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