NCT03110757

A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults

A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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(R) (10mcg, 30mcg, or 100mcg) vaccine with or without AP 10-701 given as three doses administered on Days 1, 57, and 113.

Detailed description

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 study will recruit up to 60 healthy adult males and non-pregnant females to test two formulations of Sm-TSP-2 vaccine (adjuvanted with Alhydrogel(R) only, or with Alhydrogel(R) plus AP 10-701), 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(R), 2 Sm-TSP-2/Alhydrogel(R)/AP 10-701, and 1 Euvax B 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(R) (10mcg, 30mcg, or 100mcg) vaccine with or without AP 10-701 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 ELISA at 14 days after dose one and two and Days 203, 293, and 478 (3, 6, and 12 months after the third dose) of Sm-TSP-2/Alhydrogel(R) (10mcg, 30mcg, or 100mcg) with or without AP 10-701, and (3) to assess the duration of the IgG antibody response to Sm-TSP-2 using an indirect ELISA following receipt of three doses of Sm-TSP-2/Alhydrogel(R) (10mcg, 30mcg, or 100mcg) with or without AP 10-701.

Conditions

• Schistosomiasis

Interventions

Type	Name	Description
BIOLOGICAL	GLA-AF	Previously referred to as Gluco-pyranosylphospho-lipid A aqueous formulation (GLA-AF). It is a toll-like receptor-4 agonist
BIOLOGICAL	Hepatitis B Virus Vaccine (Recombinant)	A non-infectious subunit viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast cells.
BIOLOGICAL	Sm-TSP-2/Alhydrogel	Sm-TSP-2/Alhydrogel

Timeline

• Start date: 2018-05-20
• Primary completion: 2019-11-14
• Completion: 2019-11-14
• First posted: 2017-04-12
• Last updated: 2021-02-02

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study