A Phase I Study of the Safety, Reactogenicity, & Immunogenicity of

Status Completed

Clinical Trial Summary

Clinical Trial Description

This is a Phase I, first-in-human study of a vaccine against S. mansoni infection.The study will recruit 72 healthy adult males and non-pregnant females from a single clinical center to test two formulations of Sm-TSP-2 vaccine (using the Alhydrogel® only, and using Alhydrogel® plus GLA-AF), each at 3 different doses: 10ug, 30ug, and 100ug. The study will use a dose-escalation cohort design, in which escalation to the next dose cohort will be determined based on evaluation of pre-defined escalation criteria requiring 7 day safety data to be examined after all subjects in the current cohort have received their first dose of vaccine. For each Cohort (1-3), an initial 5 subjects (2 Sm-TSP-2/Alhydrogel®, 2 Sm-TSP-2/Alhydrogel®/GLA-AF, and 1 placebo) will be enrolled, randomized, vaccinated, and have completed Visit 2 (Day 3), before enrolling the rest of the cohort. As with dose-escalation decisions, evidence of significant reactogenicity will require further review prior to proceeding.Recruitment and enrollment into the study will occur on an ongoing basis, with each cohort being recruited and vaccinated in sequence. All subjects will be assigned investigational vaccine or placebo by randomization, and a double-blind design will be used (i.e., neither the subject nor the investigator will be aware of the study product assigned: Sm-TSP-2/Alhydrogel®, Sm-TSP-2/Alhydrogel®/GLA-AF, or placebo). Each subject will receive 3 vaccinations at Days 1, 57, and 113, and will be followed for a total of 12 months after the third dose. The study duration will be approximately 24 months, and subject participation duration will be approximately 16 months. The primary objective is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel® (10ug, 30ug, or 100ug) with or without GLA-AF vaccine given as three doses administered on Days 1, 57, and 113. The secondary objectives include: (1) to assess the IgG antibody response using an indirect enzyme-linked immunosorbent assay (ELISA) at Day 127; (2) to assess the IgG antibody response using an indirect enzyme-linked immunosorbent assay (ELISA) at 14 days after dose one and two and Day 203 and 293 (3 and 6 months after the third dose) of Sm-TSP-2/Alhydrogel® (10ug, 30ug, or 100ug) with or without GLA-AF; (3) To assess the duration of the IgG antibody response using an indirect enzyme-linked immunosorbent assay (ELISA) following receipt of three doses of Sm-TSP-2/Alhydrogel® (10ug, 30ug, or 100ug) with or without GLA-AF. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02337855
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 1
Start date	February 4, 2015
Completion date	January 27, 2017

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See also
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A Phase I Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or Without GLA-AF for Intestinal Schistosomiasis in Healthy Adults

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms