Phase 1/2b Testing of the Sm-TSP-2 Schistosomiasis Vaccine in Uganda
Technical Report,30 Sep 2018,29 Sep 2019
George Washington University Washington United States
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The Project goal is to perform a Phase IIIb clinical trial to evaluate the safety and immunogenicity of the Sm-TSP-2Alhydrogeltrademark 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-2Alhydrogeltrademark 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-2Alhydrogeltrademark vs. the licensed Hepatitis B Virus HBV vaccine as a comparator 3 Assess the cellular immune response to vaccination with Sm-TSP-2Alhydrogel trademark. The study will be done in two parts. Part A will be a randomized, double-blind Phase I trial in 90 healthy Ugandan adults aged 18-45 years to test 3 doses of the vaccine, with or without AP 10-701. In each dose group 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 over 4 months and will be followed for 9 months after final injection. Part B will compare 100 people vaccinated with Sm-TSP-2 doseformulation determined in Part A to 100 people vaccinated with HBV. Part B subjects will receive 3 vaccine injections administered at 2-month intervals. After final vaccination, urine and stool samples will be collected at 12 and 18months 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. Other outcomes include studying the antibody responses to Sm-TSP-2.