For more than a decade, the Sabin PDP collaborated with partners from across the globe to develop new, low-cost vaccines that have little commercial market for diseases that primarily impact the world's poorest populations, including humanhookworm, schistosomiasis, onchocerciasis, SARS and Chagas disease. Baylor College of Medicine and Texas Children’s Hospital Center for Vaccine Development continue this research as of May 2017.
The Sabin PDP created a well-rounded partnership model that serves as a blueprint for the development of safe and effective vaccines against vaccine preventable and neglected tropical diseases.
Working with partners in the United States, Europe and South America, the Sabin PDP focused on:
Product Development: Established the infrastructure to engage in antigen discovery, rapid development of scalable manufacturing processes (process development), quality control, preclinical and clinical immunology and stability testing.
Technology Transfer and Manufacturing: Worked with manufacturers in Brazil, Mexico, and the United States to scale up developed processes for manufacture of pilot clinical lots under current good manufacturing practices (cGMP).
Epidemiological and Clinical Studies: Established a field laboratory and field clinical site, including a vaccine testing center in the endemic region of Americaninhas in the Brazilian state of Minas Gerais, for the conduct of clinical trials, including Phase 1 (first in human) trials.
Ethical and Regulatory Approvals: Completed Phase 1 clinical trials with ethical oversight from institutional review boards in the United States and Brazil and obtained regulatory approval for clinical testing from the U.S. Food and Drug Administration (FDA) and Brazilian regulatory agency, the Agencia Nacional de Vigilancia Sanitaria (ANVISA).
Photo credit: Anna Grove Photography