IVI set to develop Phase 1b/2a clinical trial of schistosomiasis vaccine

The International Vaccine Institute (IVI) has recently announced receiving grant from the Bill & Melinda Gates Foundation to develop an adaptive trial design for a Phase 1b/2a clinical trial of a vaccine for schistosomiasis.

The main aim of IVI’s schistosomiasis vaccine venture is to advance the development of an effective, affordable, and safe vaccine to reduce the mortality and morbidity rate from schistosomiasis in high- to moderate- transmission settings.

It has been reported that the company’s schistosomiasis vaccine project has already sourced funding from the National Institute of Allergy and Infectious Diseases (NIH) along with EU Horizon 2020, to support Phase 1 clinical trials of the SchistoShield vaccine.

The trials encompass a first-in-human safety analysis in healthy American adults at an NIH Vaccine and Treatment Evaluation unit followed by a Phase 1b immunogenicity and safety placebo-controlled study in healthy adults in Madagascar and Burkina Faso.

News reports suggest that with the Trial Planning Grant received by Gates Foundation, the IVI team would now be able to adapt the Phase 1b study, supporting the escalation in clinical development of the vaccine.

Speaking on the latest accomplishment, Deputy Director General of Epidemiology, Public Health, and Impact at IVI, Dr. Florian Marks cited that the company is grateful to the gates Foundation for their innate support and guidance in planning an adaptive 1b/2a phase trial for schistosomiasis vaccine candidate, to save million lives from schistosomiasis infection.

Florian added that the Trial Planning Grant is likely to accelerate the clinical development timeline as well as pre-qualification and licensure processes.

Meanwhile, Dr. Tarun Saluja, Research Scientist at IVI mentioned that with the team’s robust experience in designing adaptive trial designs for diverse vaccine candidates, the firm is looking forward to this novel opportunity to build a responsive, efficient, and comprehensive protocol to develop a critically needed schistosomiasis jab while making sure that the highest standards for data integrity and patient safety are met.

Source Credit: https://www.einnews.com/pr_news/542541072/ivi-to-develop-an-adaptive-phase-1b-2a-schistosomiasis-vaccine-clinical-trial