Norovirus Gastroenteritis
Conditions
Brief summary
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers
Detailed description
The study will enroll 66 subjects in four cohorts. All subjects will receive a single administration of VXA-G1.1-NN at a low dose, a high dose or placebo. Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to receive VXA-G1.1-NN prior to enrolling either of the randomized, controlled cohorts (Cohorts 2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group. Cohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3 subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo Subjects will be followed for 28 days post vaccination for preliminary immunogenicity. Subjects will continue to be followed for 1 year post-vaccination for long term safety.
Interventions
BIOLOGICALVXA-G1.1-NN (high dose) Oral Vaccine Tablet
The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high dose.
OTHERVXA Placebo Tablets
The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.
BIOLOGICALVXA-G1.1-NN (low dose) Oral Vaccine Tablet
The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the low dose.
Sponsors
Vaxart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female volunteers aged 18 - 49 years, inclusive 2. Able to give written informed consent 3. Healthy (no clinically significant health concerns) 4. Safety laboratory values within the following range criteria normal range 5. Body mass index between 17 and 35 at screening
Exclusion criteria
1. Receipt of any investigational norovirus vaccine within two years prior to study 2. Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination 3. Administration of any licensed vaccine within 30 days prior to study 4. 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 5. History of drug, alcohol or chemical abuse within 1 year prior to vaccination 6. Presence of a fever ≥ 38oC measured orally at baseline 7. Stool sample with occult blood at screening -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Solicited and Unsolicited Adverse Events | Day 1 thru Day 28 | Solicited Symptoms of Reactogenicity (thru Day 8); unsolicited Adverse Events thru Day 28 post vaccination |
Countries
United States
Outcome results
None listed