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
Condition: Schistosomiasis
MeSH terms: Schistosomiasis; Schistosomiasis mansoni
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): GLA-AF; Hepatitis B Virus Vaccine (Recombinant); Sm-TSP-2/Alhydrogel
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Previously referred to as Gluco-pyranosylphospho-lipid A aqueous formulation (GLA-AF). It is a toll-like receptor-4 agonist; A non-infectious subunit viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast cells.; Sm-TSP-2/Alhydrogel
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: AP 10-701; healthy adults; Immunogenicity; Phase Ib; Reactogenicity; Safety; Schistosomiasis; Sm-TSP-2/Alhydrogel®