Valneva and LimmaTech Initiate Phase 2 Study for Shigella Vaccine
Valneva and LimmaTech Begin Phase 2 Study for Shigella Vaccine S4V2
Saint Herblain and Schlieren – Valneva SE (NASDAQ: VALN; Euronext Paris: VLA), a leader in vaccine development, in partnership with LimmaTech Biologics AG, has announced the commencement of a Phase 2 study of Shigella4V2 (S4V2), targeting the critical public health issue of shigellosis. This study aims to test the vaccine's safety and immunogenicity in infants, marking a crucial milestone in their joint efforts against this deadly disease.
The Urgent Need for a Shigella Vaccine
Shigellosis remains a formidable threat, recognized as the second leading cause of severe diarrhea-related deaths globally. With an alarming estimate of 165 million infections annually, particularly among young children, the need for a preventive vaccine has never been more pressing. Shigella bacteria not only cause immense suffering but also pose significant challenges due to increasing antibiotic resistance, complicating treatment efforts.
Details of the Phase 2 Study
Study Structure and Objectives
The Phase 2 study, designated as S4V02 (Identifier: NCT06523231), will involve around 110 healthy nine-month-old infants. The focus will be on determining the optimal dosage of the vaccine to proceed into Phase 3 trials. Conducted in Kenya, this randomized, controlled, and blinded study is designed to ensure thorough evaluation of the vaccine's efficacy and safety over a timeframe of approximately six months following dosing.
Collaborative Efforts
Dr. Juan Carlos, Valneva's Chief Medical Officer, voiced the importance of this study, emphasizing that preventing shigellosis through vaccination could save countless young lives. With the backing of the World Health Organization, prioritizing the development of Shigella vaccines aligns perfectly with Valneva's mission. Furthermore, determining a viable vaccine solution against such a preventable disease underscores the company’s commitment to addressing global health challenges.
Significant Milestones in Vaccine Development
Previous and Upcoming Trials
Valneva and LimmaTech have made significant strides in vaccine research, including earlier Phase 2b controlled human infection model studies for S4V2 (Identifier: NCT06615375). These earlier trials are part of a comprehensive development strategy to ensure both safety and efficacy, ultimately leading towards regulatory approvals and market availability of the vaccine.
FDA Fast Track Designation
In recognition of the vaccine’s potential, the U.S. Food and Drug Administration has granted Fast Track designation to S4V2. This regulatory support highlights the vaccine’s importance in addressing critical health needs and ensuring swift progress towards potential market entry.
Understanding Shigellosis
Shigellosis is a serious condition caused by Shigella bacteria, leading to severe gastroenteritis and often resulting in hospitalization or death, particularly in vulnerable populations such as children. Current treatments include oral rehydration and antibiotics, but increasing antibiotic resistance calls for proactive prevention through vaccination, especially since no licensed Shigella vaccines exist today.
Who Are Valneva and LimmaTech?
Valneva SE specializes in developing innovative vaccines addressing unmet medical needs worldwide. Their dedication has led to the launch of various approved vaccines, including pioneering initiatives in infectious disease prevention, while LimmaTech Biologics focuses on combatting antimicrobial resistance through advanced vaccine technologies and robust research capabilities.
Frequently Asked Questions
What is the significance of the Phase 2 study for the Shigella vaccine?
This Phase 2 study aims to determine the safety and optimal dosing of the S4V2 vaccine in infants, which is crucial for advancing to further clinical trials.
Why is a Shigella vaccine important?
Shigellosis causes millions of infections and significant childhood mortality worldwide. A vaccine could dramatically reduce these statistics and save lives.
What is the FDA Fast Track designation?
This designation helps expedite the development of drugs and vaccines that treat serious conditions, ensuring they can reach the market more quickly.
How has Valneva previously engaged in vaccine development?
Valneva has developed several vaccines addressing other infectious diseases, showcasing their strong expertise in supporting public health through vaccination.
How can I get more information about the Shigella vaccine?
Additional information can be found directly on Valneva's or LimmaTech's websites, where they provide updates on their research and trials.
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