Clinical Trial: A Phase Ib Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or Without GLA-AF for Intestinal Schistosomiasis in Healthy Exposed Adults

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or Without GLA-AF for Intestinal Schistosomiasis in Healthy Exposed Adults

Brief Summary: The study will be conducted as a randomized, controlled, double blind Phase 1b dose-escalating clinical trial in up to 60 healthy adult males and non-pregnant females living in the S. mansoni-endemic area of Americaninhas, Brazil. The primary objective of this trial is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel® (10mcg, 30mcg, or 100mcg) vaccine with or without GLA-AF given as three doses administered on Days 1, 57, and 113.

Detailed Summary: The study will be conducted as a randomized, controlled, double blind Phase 1b dose-escalating clinical trial in up to 60 healthy adult males and non-pregnant females living in the S. mansoni-endemic area of Americaninhas, Brazil. The exploratory objective is to assess cellular immune responses following receipt of Sm-TSP-2/Alhydrogel® (10mcg, 30mcg, or 100mcg) with or without GLA-AF beginning on Study Day 1 (pre-immunization), and then on Days 8, 15, 57, 64, 71,113, 120, 127, 203, 293, and 478. The study will recruit up to 60 healthy adult males and non-pregnant females to test two formulations of Sm-TSP-2 vaccine (adjuvanted wtih Alhydrogel® only, or with Alhydrogel® plus GLA-AF), each at 3 different doses of antigen: 10mcg, 30mcg, and 100mcg. 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. Cohorts will be enrolled sequentially. For each Cohort (1-3), an initial 5 subjects (2 Sm-TSP-2/Alhydrogel®, 2 Sm-TSP-2/Alhydrogel®/GLA-AF, and 1 Butang Hepatitis B vaccine) will be enrolled, randomized, vaccinated, and have completed Visit 02 (Day 2), before enrolling the rest of the cohort. As with dose-escalation decisions, evidence of significant reactogenicity will require further review prior to proceeding. The primary objective of this trial is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel® (10mcg, 30mcg, or 100mcg) vaccine with or without GLA-AF given as three doses administered on Days 1, 57, and 113. The secondary objectives used to evaluate the immunogenicity are; (1) to assess the IgG antibody response to Sm-TSP-2 using an indirect enzyme-linked immunosorbent assay (ELISA) at Day 127, (2) to assess the IgG antibody response to Sm-TSP-2 using an indirect ELI
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • The occurrence of new-onset chronic medical conditions (including AESI) [ Time Frame: From Day 1 to Day 478 ]
  • The occurrence of solicited injection site reactogenicity [ Time Frame: From Day 1 to Day 7 ]
  • The occurrence of solicited injection site reactogenicity [ Time Frame: From Day 113 to Day 120 ]
  • The occurrence of solicited injection site reactogenicity [ Time Frame: From Day 57 to Day 64 ]
  • The occurrence of solicited systemic reactogenicity [ Time Frame: From Day 1 to Day 7 ]
  • The occurrence of solicited systemic reactogenicity [ Time Frame: From Day 113 to Day 120 ]
  • The occurrence of solicited systemic reactogenicity [ Time Frame: From Day 57 to Day 64 ]
  • The occurrence of study vaccine-related SAEs [ Time Frame: From Day 1 to Day 478 ]
  • The occurrence of vaccine-related clinical safety laboratory adverse events [ Time Frame: Day 113 ]
  • The occurrence of vaccine-related clinical safety laboratory adverse events [ Time Frame: Day 120 ]
  • The occurrence of vaccine-related clinical safety laboratory adverse events [ Time Frame: Day 57 ]
  • The occurrence of vaccine-related clinical safety laboratory adverse events [ Time Frame: Day 64 ]
  • The occurrence of vaccine-related clinical safety laboratory adverse events [ Time Frame: Day 8 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The anti-Sm-TSP-2 IgG antibody response using an indirect ELISA [ Time Frame: Day 14 ]
  • The anti-Sm-TSP-2 IgG antibody response using an indirect ELISA [ Time Frame: Day 203 ]
  • The anti-Sm-TSP-2 IgG antibody response using an indirect ELISA [ Time Frame: Day 293 ]
  • The anti-Sm-TSP-2 IgG antibody response using an indirect ELISA [ Time Frame: Day 478 ]
  • The anti-Sm-TSP-2 IgG antibody response using an indirect ELISA [ Time Frame: Day 64 ]
  • The anti-Sm-TSP-2 IgG level using an indirect ELISA [ Time Frame: Day 127 ]


Original Secondary Outcome: Same as current

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: March 21, 2017
Date Started: June 1, 2017
Date Completion: October 1, 2018
Last Updated: May 11, 2017
Last Verified: March 30, 2017