A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regim… (NCT05213728) | Clinical Trial Compass
CompletedPhase 1
A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers
United States8 participantsStarted 2022-01-24
Plain-language summary
Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 to 55 years old, inclusive, at day of signing Informed Consent Form (ICF)
✓. General good health, without significant uncontrolled medical illness, based on medical history, physical examination, vital signs, and clinical laboratories (CBC, chemistry, and urinalysis) as determined by the investigator in consultation with the Research Monitor and Sponsor
✓. Body mass index (BMI) between 17 and 35 kg/m2 at screening
✓. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
✓. Available for all planned visits and phone calls, and willing to complete all protocol-defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per study dose)
✓. Female participants must provide a negative pregnancy test at each required visit and fulfill one of the following criteria:
✓. At least 1 year post-menopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without alternative medical cause)
✓. Surgically sterile
Exclusion criteria
✕. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline
✕
What they're measuring
1
Rate of Solicited Symptoms of Reactogenicity
Timeframe: Up to Day 8
2
To assess the induction of VP1-specific Immunoglobin A (IgA) antibody-secreting cells (ASC) by ELISpot assay
Timeframe: Change from baseline at Day 8
3
To assess histo-blood group antigen (HBGA) blocking antibodies by blockade titer (BT50)
Timeframe: Change from baseline at Day 29
4
To assess VP1-specific serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay
Timeframe: Change from baseline at Day 29
5
To assess the VP1-specific serum Immunoglobin A (IgA) by Mesoscale Discovery (MSD) assay
. Cancer, or received treatment for cancer, within past 3 years (excluding basal cell carcinoma or squamous cell carcinoma)
✕. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus 1 and 2
✕. History of irritable bowel disease or other inflammatory digestive or gastrointestinal condition that could affect the distribution/safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine Norwalk GI.1 (VXA-G1.1-NN) Protocol No. VXA-NVV-106