March 2025 – The VASA Project and leading global health stakeholders convened at the Schistosomiasis Stakeholder Meeting in Bangkok, Thailand, on January 15-16, 2025, to accelerate the development of a first-ever schistosomiasis vaccine. With millions affected annually by this neglected tropical disease (NTD), the urgency to develop sustainable, long-term solutions has never been greater.
The two-day forum brought together scientists, clinicians, regulatory experts, and funding agencies to discuss the latest clinical trial advancements, regulatory strategies, and commercialization efforts for schistosomiasis vaccine development.
A Landmark Year for Schistosomiasis Vaccine Trials
A key highlight from the meeting was the successful progress of the Sm-p80-based vaccine candidate, currently undergoing trials in Madagascar and Burkina Faso. This marks a pivotal step toward Phase 2a trials and eventual global distribution. Key updates include:
- Completing Phase 1b enrollment in Madagascar (MIVR) and Burkina Faso (GRAS).
- Strong safety and immunogenicity results with dose escalation studies.
- Regulatory engagement with global agencies (KMFDS, Senegal NRA, EMA, AVAREF) to streamline vaccine approval pathways.
- Ongoing clinical development planning for Phase 2a trials, targeting both adults and children in endemic regions.
Addressing Key Scientific and Regulatory Challenges
Stakeholders engaged in critical discussions about the future of schistosomiasis vaccine development, emphasizing:
- Regulatory Strategies – Advocating for the vaccine’s inclusion on the WHO’s priority list for prequalification.
- Clinical Trial Designs – Optimizing Phase 2 and Phase 3 study endpoints to ensure efficacy across S. haematobium and S. mansoni species.
- Diagnostics & Biomarkers – Exploring CAA and egg burden reduction as key efficacy measures.
- Commercialization & Manufacturing – Partnering with Quratis for large-scale GMP production, ensuring global vaccine access post-licensure.
Next Steps: Paving the Way for Phase 2a Trials
Following the stakeholder meeting, the VASA team is now focused on:
- Finalizing the Clinical Study Report (CSR) for Phase 1b trials.
- Engaging WHO, Gavi, and global regulatory agencies to accelerate License approvals.
- Preparing Phase 2a sites in Madagascar to launch trials in Q2 2025.
Uniting for Impact: A Call to Action
Schistosomiasis remains a major global health challenge, disproportionately affecting low- and middle-income countries. The VASA Project, alongside its scientific and regulatory partners, is committed to delivering a safe, effective, and accessible vaccine to millions in need.
We extend our gratitude to our partners, researchers, and communities for their unwavering support in this fight. Stay connected with the VASA Project for more updates as we continue to break new ground in schistosomiasis vaccine development.