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 range
19 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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).
. 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
. 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.