Ab-01.12, Abera’s most advanced candidate, is being developed as a first-in-class nasal vaccine against pneumococcal disease. Existing pneumococcal vaccines target a limited number of serotypes, but Ab-01.12 could provide broad protection regardless of serotype. The vaccine is based on Abera’s proprietary BERA platform. In preclinical studies, it stimulated both local immune responses in the mucous membranes of the airways and systemic immune responses. Because it prevents pneumococci from colonizing the airways, the vaccine could both protect against disease and limit transmission. The preclinical results were recently published in npj Vaccines.

The trial is Abera’s first in humans and will primarily assess safety and tolerability in up to twenty-five healthy adults aged 18 to 49. The vaccine will be given as a nasal spray in groups receiving escalating doses. Participants in the highest-dose group will also receive a booster about eight to ten weeks after the first vaccination. Antibody levels will be measured to examine the vaccine’s immunological effects.

The study will be conducted at Radboud University Medical Center (Radboud UMC) in Nijmegen. Abera has a long-standing research collaboration in pneumococcal disease with the hospital, and that work laid the groundwork for Ab-01.12.

“This is a huge milestone for Abera. After many years of dedicated work, we have now received approval for our first clinical trial and are taking the step to becoming a clinical-stage company. It is important validation of the quality of the work our team and partners have done. Being able to evaluate our technology in humans is a decisive step, not only for Ab-01.12 but also for our broader vaccine platform and Abera’s continued development,” says Maria Alriksson, CEO of Abera Bioscience.

Before recruitment can begin, the trial still needs local approval at Radboud UMC.