Phase 1/2b Testing of the Sm-TSP-2 Schistosomiasis Vaccine in Uganda
Abstract
The Project goal is to perform a Phase I/IIb clinical trial to evaluate the safety and immunogenicity of the Sm-TSP-2/Alhydrogel(Registered trademark) schistosomiasis vaccine in Ugandan adults and obtain preliminary data on proof-of-efficacy. Specific Aims are to: (1) Assess the safety and immunogenicity of the Sm-TSP-2/Alhydrogel(Registered trademark)vaccine with or without AP 10-701 (a synthetic Toll-like Receptor-4 agonist) in individuals living in areas of Uganda endemic for S. mansoni and S. haematobium. The project will have significant impact on vaccine development for schistosomiasis that could protect U.S. service members against infection by this parasite.Progress to date in the current reporting period consists of completion of enrollment and vaccinations in Cohort 3 of Part A. All Cohort 3 participants will complete Part A by October 2021. An interim safety and immunogenicity analysis occurred in May 2021 after all Part A participants completed Day 140 of the study to determine which vaccine dose/formulation will be tested in Part B. The Safety Monitoring Committee recommended a dose of 100 mcg Sm-TSP-2/Alhydrogel vaccine with 5 mcg AP 10-701. Recruitment and screening for Part B began in July 2021. Screening and enrollment in Part B of the study will continue in Year 4.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2020
- Accession Number
- AD1156540
Entities
People
- David Diemert
Organizations
- George Washington University