Norovirus GastroenteritisPhase 1NCT03125473
Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers
A Phase 1 study testing VXA-G1.1-NN Oral Vaccine in people with Norovirus Gastroenteritis, run by Vaxart at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Norovirus Gastroenteritis
- What is being tested?
- VXA-G1.1-NN Oral Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 6 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- Female participants must have a negative pregnancy test at baseline and fulfill one of the following criteria:
- At least one year post-menopausal;
- Surgically sterile;
- Willing to use oral, implantable, transdermal or injectable contraceptives for 30 days prior to and until 60 days after vaccination;
- A reliable form of contraception must be approved by the Investigator
Who cannot join
- 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
- Any one of the following ECG findings within 30 days prior to vaccination:
- QTcF interval duration > 460 msec (male) or > 470 msec (female),
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- QRS interval greater than 120 msec,
- PR interval greater than 220 msec,
- Clinically significant ST-T wave changes or pathologic Q waves.
- 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.
- Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus.
- Administration of any medications or treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) during 3 months prior to vaccination. Inhaled and topical corticosteroids allowed.
- Presence of household members who have received the Ad4 or Ad7 vaccines within 2 months prior to vaccination.
- Presence of household members who are neonates, pregnant women, or hematopoietic stem cell transplant or solid organ transplant recipients from screening until the end of the active period
- History of drug, alcohol or chemical abuse within 1 year prior to vaccination.
- Receipt of blood or blood products 6 months prior to vaccination or planned administration during the follow-up study period.
- Donation of blood or blood products within 4 weeks prior to vaccination or planned donation during the study period.
- Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness with or without fever.
- during screening period).
- Presence of fever ≥38oC
- Stool sample with occult blood
- Positive urine drug screen for drugs of abuse
- Positive urine alcohol test at
- Consistent/habitual smoking within 2 months prior to vaccination.
- History of serious reactions to any vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain.
- Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Open-Label, Dose-Optimization Trial of an Adenoviral-vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers
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
Read the detailed description
This study will enroll approximately 60 subjects in four cohorts of 15 subjects each. The cohorts may be enrolled and run in parallel or overlap; they do not have to run sequentially. The dosing for each cohort will be as follows:
Cohort 1: Multiple low dose on Days 1 and 8 Cohort 2: Multiple low dose on Days 1, 3 and 5 Cohort 3: Multiple low dose on Days 1 and 29 Cohort 4: Multiple high dose on Days 1 and 29
All subjects receiving study drug will have safety and immunogenicity assessments completed through Study Day 57 following their initial vaccination. Subjects may also be evaluated for persistent immunogenicity at Day 180 and will be followed for safety for 12 months following initial vaccination (Study Day 365).
- Conditions
- Norovirus Gastroenteritis
- Being tested
- VXA-G1.1-NN Oral Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VXA-G1.1-NN Oral VaccineBiological
Also called Active VXA-G.1.1-NN Oral Tablet Vaccine
The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high total doses.
| Study group | Role | What they receive |
|---|---|---|
| Dose Group 1 | Experimental | Multiple doses of low dose VXA-G1.1-NN Oral Vaccine Tablets will be orally administered. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk. Subjects will receive 1 tablet of VXA-G1.1-NN on Days 1 and 8 Receives: Biological: VXA-G1.1-NN Oral Vaccine |
| Dose Group 2 | Experimental | Multiple doses of low doseVXA-G1.1-NN Oral Vaccine Tablets will be orally administered. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk. Subjects will receive 1 tablet of VXA-G1.1-NN on Days 1, 3, and 5 Receives: Biological: VXA-G1.1-NN Oral Vaccine |
| Dose Group 3 | Experimental | Multiple doses of low dose VXA-G1.1-NN Oral Vaccine Tablets will be orally administered. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk. Subjects will receive 1 tablet of VXA-G1.1-NN on Days 1 and 29. Receives: Biological: VXA-G1.1-NN Oral Vaccine |
| Dose Group 4 | Experimental | Multiple doses of low dose VXA-G1.1-NN Oral Vaccine Tablets will be orally administered. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk. Subjects will receive 6 tablets of VXA-G1.1-NN on Days 1 and 29 Receives: Biological: VXA-G1.1-NN Oral Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Safety will be evaluated by local and systemic reactogenicity (solicited symptoms), and clinical and laboratory assessments including physical exams, vital signs, clinical laboratory tests (hematology, serum chemistry, and urinalysis), and adverse events (AEs).
Measured: Day 1 thru Day 57
Secondary outcomes (1)
Evaluate the effect of different dosing regimens of VXA-G1.1-NN vaccine on its immunogenicity as determined by cellular and humoral immune function assays performed on blood samples collected at preselected study visits.
All subjects will have blood samples collected on study days 7, 28, and 57 following their initial vaccination for cellular and humoral immune function assays (i.e., production of vaccine specific blocking and neutralizing antibodies, formation of vaccine specific antibody secreting and memory cells, etc.) to assess the effect of the different dosing schedules on the immunogenicity of the VXA-G1.1-NN vaccine. Subjects may also be evaluated for persistent immunogenicity at Day 180 (optional).
Measured: Day 1 thru Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start7 Apr 2017
- Primary completion1 Jul 2017
- Study completion6 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Norovirus GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Sterling, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125473
- Sponsor's protocol ID
- VXA-G11-102
- Status last verified
- May 2018
- First submitted
- 14 Apr 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Dose-Optimization Trial of an Adenoviral-vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03125473
- Acronym / sponsor ID
- VXA-G11-102
- Conditions
- Norovirus Gastroenteritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 6 May 2018 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study will enroll approximately 60 subjects in four cohorts of 15 subjects each. The cohorts may be enrolled and run in parallel or overlap; they do not have to run sequentially. The dosing for each cohort will be as follows:
Cohort 1: Multiple low dose on Days 1 and 8 Cohort 2: Multiple low dose on Days 1, 3 and 5 Cohort 3: Multiple low dose on Days 1 and 29 Cohort 4: Multiple high dose on Days 1 and 29
All subjects receiving study drug will have safety and immunogenicity assessments completed through Study Day 57 following their initial vaccination. Subjects may also be evaluated for persistent immunogenicity at Day 180 and will be followed for safety for 12 months following initial vaccination (Study Day 365).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Group 1 | Experimental | Biological: VXA-G1.1-NN Oral VaccineMultiple doses of low dose VXA-G1.1-NN Oral Vaccine Tablets will be orally administered. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk. Subjects will receive 1 tablet of VXA-G1.1-NN on Days 1 and 8 |
| Dose Group 2 | Experimental | Biological: VXA-G1.1-NN Oral VaccineMultiple doses of low doseVXA-G1.1-NN Oral Vaccine Tablets will be orally administered. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk. Subjects will receive 1 tablet of VXA-G1.1-NN on Days 1, 3, and 5 |
| Dose Group 3 | Experimental | Biological: VXA-G1.1-NN Oral VaccineMultiple doses of low dose VXA-G1.1-NN Oral Vaccine Tablets will be orally administered. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk. Subjects will receive 1 tablet of VXA-G1.1-NN on Days 1 and 29. |
| Dose Group 4 | Experimental | Biological: VXA-G1.1-NN Oral VaccineMultiple doses of low dose VXA-G1.1-NN Oral Vaccine Tablets will be orally administered. VXA-G1.1-NN is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of noroviral gastroenteritis caused by Norovirus GI.1. The vaccine vector encodes for a full length VP1 (major capsid protein) gene from Norvirus GI.1 Norwalk. Subjects will receive 6 tablets of VXA-G1.1-NN on Days 1 and 29 |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (29 listed)
- 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
- Any one of the following ECG findings within 30 days prior to vaccination:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VXA-G1.1-NN Oral VaccineAlso: Active VXA-G.1.1-NN Oral Tablet VaccineThe drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high total doses. | Biological | Dose Group 1, Dose Group 2, Dose Group 3, Dose Group 4 |
Primary outcome
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).
Time frame: Day 1 thru Day 57
Safety will be evaluated by local and systemic reactogenicity (solicited symptoms), and clinical and laboratory assessments including physical exams, vital signs, clinical laboratory tests (hematology, serum chemistry, and urinalysis), and adverse events (AEs).
1 secondary outcome
Evaluate the effect of different dosing regimens of VXA-G1.1-NN vaccine on its immunogenicity as determined by cellular and humoral immune function assays performed on blood samples collected at preselected study visits.
Time frame: Day 1 thru Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Norovirus Gastroenteritis
RecruitingPhase 1
A Study to Evaluate INT101 in Healthy Adults for the Prevention of Norovirus Gastroenteritis
Norovirus Infections, Norovirus Gastroenteritis
Active, not recruitingPhase 3
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
Acute Gastroenteritis, Norovirus Acute Gastroenteritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Sterling, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VXA-G1.1-NN Oral Vaccine in people with Norovirus Gastroenteritis, run by Vaxart at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Day 1 thru Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.