As an unprecedented Lassa fever outbreak devastates Nigeria, Themis plans to start in-human testing of its vaccine against the deadly disease as early as this year, with help from $37.5 million in funding from the public-private vaccine alliance the Coalition for Epidemic Preparedness Innovations.
Themis aims to generate safety and immunogenicity data in about three years, to lay the groundwork for emergency use. The first step is to enter the clinic early next year, or even late this year, Themis CEO Erich Tauber told FiercePharma. Tauber said the World Health Organization and the Nigerian government, as well as Western regulatory bodies, are discussing a regulatory framework for emergency use in the Lassa case.
“Most believe that the traditional licensure pathways, as we saw during the Ebola crisis, are not suitable for these cases, and we will work closely—in our partnership with CEPI—with the institutions … to make vaccines available as soon as possible,” he said.
After the largest Ebola epidemic in history caught the world off guard in 2014, WHO created its Emergency Use Assessment and Listing Procedure, which lays out assessment processes for in-development medical products—vaccines included—for deployment in a crisis.
Under that pathway, vaccine candidates are required to show clinical data on dosing, safety and immunogenicity "in the population in which the vaccine will be used in the context of the public health emergency.” Although early safety and immunogenicity data on vaccines can be gathered in phase 1, phase 2 is when the optimal dose will be determined.
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Tauber also insisted that relevant clinical data are necessary, even in the face of an emergency.
“We must firmly state that novel vaccines will need to demonstrate sufficient levels of safety and protective capabilities before they will be given in emergency situations—also in sometimes difficult medical and infrastructural environments,” said Tauber. “I could envisage that phase 2 completion will be a reasonable time point for the Lassa fever vaccine, and we aim to be there in approximately three to four years.”
No Lassa fever vaccine has entered human testing so far, and Themis’ candidate will likely be the first. The shot will be based on antigen discovery made by Institut Pasteur and applies the company’s measles vector platform, which has already been used in clinical vaccine programs for Chikungunya and Zika. The Austrian company recently received a $37.5 million commitment from CEPI to work on the candidate and a MERS shot.