Therapy Areas: Vaccines
PAI Life Sciences Doses First Healthy Volunteer in Schistosomiasis Vaccine Clinical Trial
1 June 2022 - - US-based biotechnology company PAI Life Sciences has dosed the first healthy volunteer in a clinical trial of SchistoShield, the company's preventive vaccine against schistosomiasis, a major tropical disease threatening nearly 1bn people in 79 countries with more than 260m people currently infected, the company said.

Schistosomiasis, also known as snail fever, is a disease caused by parasitic flatworms, called schistosomes.

The worms enter human skin that comes in contact with contaminated fresh water. They are found in sub-Saharan Africa, Middle East, Southeast Asia and the Caribbean.

Once in the bloodstream, the parasites usually first enter the urinary tract or the intestines. Initial symptoms include abdominal pain, bloody stools, diarrhea and blood in the urine. Long term infections can cause liver damage, kidney failure, infertility, bladder cancer and death.

The vaccine has shown to ameliorate disease, kills adult worms, and reduce fecundity in preclinical animal models, if proven clinically, could be a significant new tool added to the toolbox for global schistosomiasis elimination effort.

The Phase 1, open-label, dose-escalation trial will evaluate the safety and the immunogenicity of PAI Life Sciences's SchistoShield vaccine candidate in 45 healthy adults between 18 and 55 years of age.

Five treatment groups, each including nine subjects, will receive three intramuscular injections at different doses.

One group will receive the vaccine without an adjuvant (which acts to increase immune responses) and four will receive the vaccine with an adjuvant. Estimated completion date is April 2024.

The National Institute of Allergy and Infectious Diseases of the National Institutes of Health is sponsoring the Phase 1 trial.

The study site is Kaiser Permanente Washington Health Research Institute, one of the NIAID- funded Vaccine and Treatment Evaluation Units; Lisa Jackson, MD, MPH, senior investigator, is the study principal investigator.

PAI Life Sciences Inc. licensed the vaccine from the Texas Tech University Health Sciences Center.

Texas Tech University Health Sciences Center (TTUHSC) is a comprehensive institution of higher education that also provides patient care and conducts biomedical clinical research across six campuses in the state of Texas.

The university, which is comprised of six schools (medicine, nursing, health professions, pharmacy, graduate school of biomedical sciences and population and public health), graduates more health care professionals than any other institution in the state.

The institution achieved Carnegie Classification status for Special Focus Four-Year Research Institutions in 2022 and is a recognized Hispanic Serving Institution by the US Department of Education.

Founded in 1969, TTUHSC has trained more than 28,000 health care professionals to date and is a member of the Texas Tech University System.

PAI Life Sciences is a biotechnology company located in Seattle, Washington, specialized in the developmental and translational research necessary to bring products from the laboratory to bedside.