Valneva and LimmaTech vaccinate first participants in phase 2 infant study of tetravalent shigella vaccine candidate S4V2

Valneva SE,  a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2 infant safety and immunogenicity study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate vaccine candidate against shigellosis. 

Shigellosis is the second leading cause of fatal diarrheal disease worldwide, strongly contributing to pediatric morbidity and mortality. It is estimated that up to 165 million infections are due to Shigella of which 62.3 million occur in children younger than five years. Developing an effective vaccine to prevent this deadly disease is a public health imperative for many areas of the world. 

In the Phase 2 study S4V02, the safety and immunogencity of S4V2 will be tested in approximately 110 nine-month-old infants with the goal of identifying the best dose to be tested in a Phase 3 trial. Sponsored and conducted by LimmaTech, S4V02 is a randomized, controlled, and blinded study conducted at a single study site in Kenya. Participants will receive a two-dose vaccination with one of two different vaccine dose levels of S4V2 or a control vaccine. Safety will be evaluated throughout the trial for approximately six months following the last vaccination. Results of the study, which is supported by funding from the Gates Foundation, are expected in the second half of 2025.