LimmaTech Biologics announces the start of a Phase I/II trial of a novel Klebsiella vaccine candidate.
Schlieren (Zurich), 8 July 2021 – LimmaTech Biologics AG today announced the start of a Phase I/II clinical trial in Germany of a 4-valent candidate vaccine to help prevent Klebsiella infections. LimmaTech is developing the asset in collaboration with GSK.
Klebsiella is a bacterium threatening humans in many different settings, including hospitals and in the community, often related to infections of the blood, urinary tract, or lungs. These infections can be severe and are associated with high mortality in intensive care units, infants, elderly, hospitalized patients, immunocompromised, and those with chronic diseases. Both the World Health Organization and the United States Centers for Disease Control and Prevention (CDC) list Klebsiella as a priority for urgent intervention due to the alarming increase in antibiotic resistance. Without new antibiotics, the first effective vaccine against Klebsiella would be a very significant advance.
To help address this serious threat, LimmaTech and GSK have developed a tetravalent bioconjugate vaccine. It includes O-antigens (to target the serogroups causing the most infections) combined with GSK’s proprietary adjuvant system, which has already demonstrated it can provide strong immune responses in people of all ages including older adults. The Phase I/II study has received approval from the German regulatory agency (Paul Ehrlich Institute) and this week marked the start of the randomized, observer-blind, placebo-controlled clinical trial. The primary objectives of the study are the safety and tolerability of the vaccine as well as the immunogenicity.