BioNTech has announced this Friday the initiation of a phase 1 study in humans with BNT165b1, the first candidate of its malaria vaccine with mRNA technologyalready used in the vaccine against Covid-19.
As reported by the German company in a statement, this placebo-controlled and observer-blind trial will include about 60 healthy volunteers with no history of prior or current malaria infection in various locations in the United States. The vaccine will be evaluated at three dose levels.
BioNTech will initially evaluate a set of mRNA-encoded antigens from the malaria-causing parasite, Plasmodium falciparum (P. falciparum), to help select the vaccine candidate that will advance to planned trials in later phases. This first clinical trial will evaluate the exploratory safety, tolerability and immunogenicity of the BNT165b1 vaccine candidate.
The World Health Organization (WHO) has estimated that in 2021 there were more than 247 million cases of malaria and 619,000 associated deaths. ‘P. falciparum’ caused the majority of deaths in sub-Saharan Africa.
95 percent of all cases occurred in the African region, with children under 5 years of age being the most vulnerable population, due to the high risk of severe disease progression and chronic complications.
Until now, a vaccine has been approved in children for the prevention of malaria infection, but there remains a medical need to develop and manufacture highly effective vaccines that prevent malaria caused by ‘P. falciparum’ to achieve the goal of malaria eradication and reduce the physical and socioeconomic burden of malaria in highly endemic areas.
“The start of the trial is an important milestone in our efforts to help address diseases with high unmet medical need. Our goal is to develop a vaccine that can help prevent malaria and reduce mortality. In the coming months we intend to test different antigens with scientific rigor to identify the optimal candidate,” said BioNTech’s Chief Medical Officer and Co-Founder, Özlem Türeci.
This clinical trial is part of a BioNTech project announced in July 2021 that has two main objectives. First, develop a mRNA vaccine “well tolerated and highly effective with durable protective immunity« to prevent blood-stage malaria infection, clinical disease and disease-associated mortality, as well as the reduction of secondary transmissions.
The second objective is to develop sustainable vaccine production and supply solutions on the African continent, including its first mRNA vaccine manufacturing kit (BioNTainer), which aims to help strengthen Africa’s capacity to detect, prevent, control and respond rapidly. and effectively to disease threats.
Containers for the first BioNTainer have completed construction in Europe and are being prepared for shipment to Kigali, Rwanda, where they are expected to arrive in the first quarter of 2023.