A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) Wit… (NCT03110757) | Clinical Trial Compass
CompletedPhase 1
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
Brazil60 participantsStarted 2018-05-20
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent prior to any study procedures.
✓. Able to understand and comply with planned study procedures and be available for all study visits.
✓. Male or non-pregnant female aged 18 to 50, inclusive at the time of enrollment.
✓. Are in good health, as determined by vital signs (oral temperature, pulse, and blood pressure), medical history, and brief physical examination at screening.
Exclusion criteria
✕. Vital signs (oral temperature, pulse, and blood pressure) are all within normal protocol-defined ranges.
✕The normal protocol-defined ranges for vital signs include (a) oral temperature less than 38.0 degrees celsius, (b) pulse 50 to 100 bpm, inclusive, (c) systolic blood pressure 85 to 150 mmHg, inclusive, and (d) diastolic blood pressure 55 to 90 mmHg, inclusive. Pulse rate \<50 is acceptable for 2nd and 3rd vaccinations if the subject is otherwise healthy with documented sinus bradycardia at baseline.
✕. Laboratory tests (alanine aminotransferase, creatinine, white blood cell count, hemoglobin, and platelets) are all within protocol-defined reference ranges.
What they're measuring
1
The occurrence of new-onset chronic medical conditions (including AESI)
Timeframe: From Day 1 to Day 478
2
The occurrence of solicited injection site reactogenicity
Timeframe: From Day 1 to Day 7
3
The occurrence of solicited injection site reactogenicity
Timeframe: From Day 113 to Day 120
4
The occurrence of solicited injection site reactogenicity
Timeframe: From Day 57 to Day 64
5
The occurrence of solicited systemic reactogenicity
Timeframe: From Day 1 to Day 7
6
The occurrence of solicited systemic reactogenicity
Timeframe: From Day 113 to Day 120
7
The occurrence of solicited systemic reactogenicity
Timeframe: From Day 57 to Day 64
8
The occurrence of study vaccine-related SAEs
Timeframe: From Day 1 to Day 478
Trial details
NCT IDNCT03110757
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕The protocol-defined ranges for laboratory tests include (a) alanine aminotransferase (ALT) of less than 1.25-times the upper reference limit, (b) creatinine less than 1.25 times the upper reference limit (c) white blood cells (WBC) between 3.3 x10\^3/uL and 10.4 x10\^3/uL, inclusive, (d) hemoglobin 11.4 g/dL or greater for females or 12.1 g/dL or greater for males, (e) platelets greater than 130 x10\^3/uL. Laboratory test results for 2nd and 3rd vaccinations may be at Grade 1 if considered unrelated to study product.
✕. Urinalysis with no greater than trace protein and negative for glucose.
✕. Female subjects of childbearing potential must agree to practice highly effective contraception for a minimum of 30 days prior to study product exposure and for 30 days after last vaccination.
✕. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
✕0. Able to correctly answer all questions on the informed consent comprehension questionnaire.
9
The occurrence of vaccine-related clinical safety laboratory adverse events
Timeframe: Day 113
10
The occurrence of vaccine-related clinical safety laboratory adverse events
Timeframe: Day 120
11
The occurrence of vaccine-related clinical safety laboratory adverse events
Timeframe: Day 57
12
The occurrence of vaccine-related clinical safety laboratory adverse events
Timeframe: Day 64
13
The occurrence of vaccine-related clinical safety laboratory adverse events