This is a Phase 1, open-label, dose-escalation clinical trial to evaluate the safety, reactogenicity, and immunogenicity of the Sm-p80+GLA-SE vaccine candidate in healthy adults between 18 and 55 years of age. Forty-five subjects will receive a series of three intramuscular injections 28 days apart with dose based on group. Five treatment groups, each including nine subjects, will receive three intramuscular (IM) injections of 0.5 mL of the designated study product on either Days 1, 29, and 57 or on Days 1, 29, and 180 (Table 1). Group A (unadjuvanted comparator) will receive 100 micrograms Sm-p80 alone on Days 1, 29, and 57, Group B (low dose standard schedule) will receive 10 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29 and 57, Group C (mid dose delayed booster) will receive 30 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29 and 180, Group D (mid dose standard schedule) will receive 30 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29, and 57, and Group E (high dose standard schedule) will receive 100 micrograms Sm-p80 + 5 micrograms GLA-SE on Days 1, 29 and 57. Study duration is approximately 20 months and will be conducted at one site in the US. Participant duration for subjects is 15 months. The primary objective is to assess the safety and reactogenicity following receipt of three doses of 1) 100 micrograms Sm- p80 (unadjuvanted), 2) 10 micrograms Sm-p80 + 5 micrograms GLA-SE, 3) 30 micrograms Sm-p80 + 5 micrograms GLA- SE, and 4) 100 micrograms Sm-p80 + 5 micrograms GLA-SE administered intramuscularly on Days 1, 29, and 57 and 5) 30 micrograms Sm-p80 + 5 micrograms GLA- SE administered on Days 1, 29, and 180.
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Number of Participants Reporting Serious Adverse Events (SAEs) Throughout the Study
Timeframe: Through 12 months after the last study vaccination. For Groups A, B, D, E: Day 1 through Day 422. For Group C: Day 1 through Day 545
Number of Participants Reporting Solicited Reactogenicity Events Within 7 Days Post Each Dose
Timeframe: For Groups A, B, D, E: Post Dose 1 Day 1 through Day 8, Post Dose 2 Day 29 through Day 36, Post Dose 3 Day 57 through 64. For Group C: Post Dose 1 Day 1 through Day 8, Post Dose 2 Day 29 through 36, Post Dose 3 Day 180 through Day 187.
Number of Participants Reporting Chemistry Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose
Timeframe: Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208
Number of Participants Reporting Hematology Laboratory Adverse Events (AEs) Within 28 Days Post Each Dose
Timeframe: Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208
Number of Participants Reporting Unsolicited Adverse Events (AEs) Within 28 Days Post Each Dose
Timeframe: Through 28 days after each study vaccination. For Groups A, B, D, E: Day 1 through Day 85. For Group C: Day 1 through Day 57, Day 180 through Day 208
Number of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), New Onset Chronic Medical Condition (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs)
Timeframe: Through 12 months after the last study vaccination. For Groups A, B, D, E: Day 1 through Day 422. For Group C: Day 1 through Day 545