IVI to develop adaptive phase 1b / 2a schistosomiasis vaccine clinical trial
SEOUL, REPUBLIC OF KOREA, May 31, 2021 /EINPresswire.com/ – The International Vaccine Institute (IVI) today announced that the Bill & Melinda Gates Foundation has awarded a grant to IVI to develop a trial design protocol adaptive for a phase 1b / 2a clinical trial of a vaccine against schistosomiasis.
The grant is a trial planning grant, which is part of the Gates Foundation’s Design, Analysis, Communication (DAC) program, which helps grantees to optimize clinical studies in terms of informativeness and impact. The goal of the IVI Schistosomiasis Vaccine Project is to advance the development of a safe, effective and affordable vaccine to reduce morbidity and mortality from schistosomiasis in moderate to high transmission settings.
Dr Florian Marks, Deputy Director General of Epidemiology, Public Health and Impact at IVI, said: “A safe, effective and accessible vaccine is the most sustainable solution to breaking the devastating cycle of infection with schistosomiasis and will save lives and improve the livelihoods of hundreds of millions of people. We thank the Gates Foundation for their support and guidance in planning an adaptive phase 1b / 2a clinical trial for a schistosomiasis vaccine candidate that would speed up the clinical development timeline as well as the approval and pre-approval processes. qualification.
Dr. Thea Norman, PhD, Design, Analyze Program Manager, Communicate, said: “IVI is an example of the type of partner the DAC program is looking for. IVI was an early adopter of our trial planning grants, operates in the field in low-resource environments, and now adds an approach to answer more questions during a trial. “
The IVI Schistosomiasis Vaccine Project has successfully secured funding from the National Institute of Allergy and Infectious Diseases (NIH) and EU Horizon 2020 to support Phase 1 clinical trials of the SchistoShield vaccine. These trials include an initial safety study in humans in healthy US adults in an NIH vaccine and treatment evaluation unit, followed by a Phase 1b safety and immunogenicity study. placebo-controlled in healthy adults in Burkina Faso and Madagascar. With this trial planning grant from the Gates Foundation, the IVI team will be able to tailor the design of the Phase 1b study, which could help accelerate the clinical development of the vaccine.
Dr Tarun Saluja, Research Scientist at IVI, said: “With the experience of the IVI team in designing adaptive trial plans for various vaccine candidates, we look forward to this opportunity to develop a comprehensive protocol, responsive and effective in advancing a schistosomiasis vaccine while ensuring the highest standards of patient safety and data integrity. ”
Schistosomiasis is a parasitic disease caused by the trematode worms of the genus Schistosoma and is the cause of significant morbidity for around 200 million people, with 779 million additional individuals at risk of infection with the highest burden in Africa. sub-Saharan. The only treatment currently available is praziquantel (PZQ), which is effective against all species of Schistosoma; however, PZQ treatment does not prevent re-infection and mass drug administration programs have shown suboptimal results and poor durability.
SchistoShield® (Sm-p80 adjuvanted in GLA-SE) is a schistosomal vaccine candidate that has shown satisfactory safety and a good efficacy profile in studies in non-human primates. The candidate exhibits multiple mechanisms of action in the schistosome life cycle and could therefore potentially prove to be a valuable tool to break the cycle of schistosomiasis infection.
About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is an intergovernmental non-profit organization created in 1997 at the initiative of the United Nations Development Program (UNDP). IVI has 36 signatory countries and the World Health Organization (WHO) on its treaty, including Korea, Sweden, India and Finland as public funders.
Our mandate is to make vaccines available and accessible to the world’s most vulnerable people. We focus on infectious diseases of global health significance such as cholera, typhoid, shigella, salmonella, schistosomiasis, chikungunya, group A streptococcus, hepatitis A, HPV, tuberculosis , HIV, MERS, COVID-19, as well as antimicrobial resistance. For more information, please visit https://www.ivi.int