Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers (NCT03125473) | Clinical Trial Compass
CompletedPhase 1
Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers
United States66 participantsStarted 2017-04-07
Plain-language summary
A Phase 1b, randomized, double-blind, dose-ranging trial to determine the safety of different dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1 VP1 and dsRNA adjuvant administered orally to healthy volunteers
Who can participate
Age range19 Years – 49 Years
SexALL
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Inclusion criteria
✓. Male or female volunteers aged 19 - 49 years
✓. Able to give written informed consent.
✓. Healthy (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, and vital signs at screening.
✓. Safety laboratory values within the following range criteria at screening or abnormal and not clinically significant as outlined within the clinical protocol
✓. Body mass index between 17 and 35 inclusively (kg/m2)
✓. Comprehension of the study requirements with ability and willingness to complete all assessments and comply with scheduled visits and contacts.
✓. Female participants must have a negative pregnancy test at baseline and fulfill one of the following criteria:
✓. At least one year post-menopausal;
Exclusion criteria
✕. Receipt of any investigational norovirus vaccine within past 2 years
✕. Administration of any investigational vaccine, drug or device within 8 weeks preceding vaccination, or planned use of the above stated during the study through the 12-month safety follow-up.
✕. Administration of any licensed vaccine within 30 days prior to vaccination.
✕. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or dose alteration for uncontrolled symptoms or drug toxicity within 3 months
What they're measuring
1
Evaluate the safety of different dosing regimens of VXA-G1.1-NN vaccine as determined by the incidence of treatment-emergent adverse events, physical exams, vital signs, and clinical laboratory test results (hematology, serum chemistry, and urinalysis).
✕. Any one of the following ECG findings within 30 days prior to vaccination:
✕. Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies.
✕. Cancer, or treatment for cancer treatment, within past 3 years (excluding history of basal cell carcinoma, squamous cell carcinoma, or cervical cancer in situ).
✕. History of a hypersensitivity or allergic reaction to any component of the investigational vaccine or placebo, including but not limited to fish gelatin. Subjects with known fish allergies should be excluded.