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; (2) Compare the incidence and intensity of reinfection with S. mansoni at 12 and 18 months following vaccination with Sm-TSP-2/Alhydrogel(registered trademark) vs. the licensed Hepatitis B Virus (HBV) vaccine as a comparator; (3) Assess the cellular immune response to vaccination with Sm-TSP-2/Alhydrogel(registered trademark). The study will be done in two parts. Part A will be a randomized, double-blind, controlled, dose escalation Phase I trial in 90 healthy Ugandan adults aged 18-45 years too test 3 doses (10 mcg, 30 mcg and 100 mcg) of the vaccine, with or without AP 10-701. In each cohort of 30 people, 12 will receive the Sm-TSP-2 vaccine alone, 12 will receive the Sm-TSP-2 vaccine mixed with AP 10-701, and 6 will receive the control HBV. Subjects will receive 3 intramuscular injections on Days 0, 56 and 112 and will be followed for 9 months after final injection. Part B will compare 100 people vaccinated with Sm-TSP-2 (dose/formulation determined in Part A) to 100 people vaccinated with HBV. Part B subjects will receive 3 intramuscular injections administered at 2-month intervals. After final vaccination, urine and stool samples will be collected at 12 and 18 months after the 3rd injection to determine rates of new schistosome infections. The primary endpoint is to determine if vaccination prevents infection with the schistosome worm as determined by schistosome worm eggs found in feces or urine.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2020
- Accession Number
- AD1126869
Entities
People
- David Diemert
Organizations
- George Washington University