Open Orphan plc changed its name to hVIVO plc on 26 October 2022, learn more here.
Malaria is a serious and life-threatening, mosquito borne disease prevalent across much of tropical and sub-tropical Asia, South America and Sub-Saharan Africa. Due to increasing resistance to current antimalarial regimens, new drugs are required as both stand-alone and partner therapies to address a growing medical need. New therapies will not only reduce mortality and disease in vulnerable populations, but also to help the move towards a greater goal of malaria elimination. Malaria is classified as an unmet need in healthcare. In 2015 the World Health Assembly endorsed aims to reduce malaria burden by 90% by 2030.
Here at hVIVO, we are developing further capability and capacity in its unique Human Challenge facilities to assist in the advancement of novel antimalarial drug and vaccine candidates and is now able to offer a Direct Venous Inoculation (DVI), Controlled Human Malaria Infection (CHMI) model for estimations of efficacy. Results from CHMI modelling of drug and vaccine efficacy have shown good translation into the field.
Reproducibility: Sanaria PfSPZ Challenge has been used in multiple clinical trials in the United Kingdom, United States, Europe, Australia and Africa.
Standardisation: A GMP manufactured P. falciparum sporozoite challenge agent (Sanaria PfSPZ Challenge)
Reproducibility: Sanaria PfSPZ Challenge Experience: As of June 2021, 1,204 volunteers have received 2,011 doses of Sanaria PfSPZ Challenge (NF54) with no deaths, unresolved significant adverse events, or sequelae to date. We have successfully completed a familiarisation study in 2022 – results to be presented at the British Society of Parasitology in March.
Safety: Documented symptoms are mostly mild to moderate and include headache, fever, nausea and fatigue.
Demonstrating efficacy of novel malaria vaccines in the field is time-consuming, costly and associated with risk
Establishing efficacy of antimalarials in early clinical trials is challenging