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Norovirus InfectionsPhase 1/2VXA-NVV-105NCT04875676

Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

A Phase 1/2 study testing VXA-G1.1-NN in people with Norovirus Infections, run by Vaxart at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55, inclusive, and to assess the safety and tolerability of VXA- G1.1-NN with repeat-dose administration at varying boost schedules (Week 4, 8… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Norovirus Infections
What is being tested?
VXA-G1.1-NN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
30 Apr 2021to 16 Feb 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • To be eligible for this study, participants must meet all the following:
  • Age
  • 18 to 55 years old inclusive at the time of signing the Informed Consent Form (ICF).
  • Type of Participants
  • 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
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  • 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).
  • Gender and Reproductive Considerations
  • Male or female participants Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • 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 an alternative medical cause).
  • Women under 60 years will need to verify post-menopausal status via a follicle-stimulating hormone (FSH) test if another option to prevent potential pregnancy will not be utilized for 30 days prior to baseline vaccination and until 60 days after the last vaccination.
  • Surgically sterile
  • Use of oral, implantable, transdermal or injectable contraceptives for 30 days prior to initial vaccination and until 60 days after the last vaccination. The form of contraception must be approved by the Investigator
  • A reliable form of contraception must be approved by the Investigator (e.g., double barrier method, Depo-Provera, intrauterine device, Norplant, oral contraceptives, contraceptive patches).
  • Not be sexually active (abstinent) or be in a relationship with partner who is sterile (must be discussed with site staff and documented).
  • Informed Consent
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Who cannot join

  • The participants must be excluded from participating in the study if they meet any of the following:
  • Medical Conditions
  • 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
  • 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.
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  • Such conditions may include but are not limited to:
  • Esophageal Motility Disorder
  • Malignancy
  • Malabsorption
  • Pancreaticobiliary disorders
  • Irritable bowel syndrome
  • Inflammatory Bowel Disease
  • Surgical Resection
  • GERD
  • Hiatal Hernia
  • Peptic Ulcer (History of cholecystectomy is not exclusionary)
  • History of any form of angioedema
  • 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
  • Any condition that resulted in the absence or removal of the spleen
  • Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical exam). (Assessment may be repeated during screening period.)
  • Presence of a fever ≥ 38oC measured orally at baseline (Assessment may be repeated during screening period)
  • Any significant hospitalization within the last year which in the opinion of the Investigator or Sponsor could interfere with study participation.
  • Any other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a participant taking in the study, would render the participant unable to comply with the protocol or would interfere with the evaluation of the study endpoints Diagnostic Assessments
  • Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) tests at the screening visit
  • Positive urine drug screen for drugs of abuse at screening
  • Positive breath or urine alcohol test at screening and baseline Prior/Concurrent Therapy
  • Receipt of a licensed vaccine within 14 days prior to baseline vaccination or planned administration during the study active period (4 weeks post each study vaccination).
  • Use of antibiotics, proton pump inhibitors, H2 blockers or antacids within 7 days prior to study drug administration or planned use during the active study period
  • Use of medications known to affect the immune function (e.g., systemic corticosteroids and others) within 2 weeks before study drug administration or planned use during the active study period
  • Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration or planned use during the active study period
  • Administration of any investigational vaccine, drug or device within 8 weeks preceding study drug administration (Day 1), or planned use within the duration of the study Other Exclusions
  • Donation or use of blood or blood products within 30 days prior to study drug administration or planned donation during the active study period
  • History of drug, alcohol or chemical abuse within 1 year of screening
  • History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin

Trial locations and contacts

1 site in 1 country.

United States1 site

  • WCCT Global, Inc.

    Cypress, California, 90630

Other trials in United States

About this study

Official title: A Phase 1b, Open-label, Boost-optimization Study of an Adenoviral- Vector Based Oral Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 Administered Orally to Healthy Adult Volunteers

To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55, inclusive, and to assess the safety and tolerability of VXA- G1.1-NN with repeat-dose administration at varying boost schedules (Week 4, 8 or 12) in healthy adults aged 18-55, inclusive

Being tested
VXA-G1.1-NN
Medical subject headings
Caliciviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VXA-G1.1-NNBiological

    Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant

Study groups in NCT04875676
Study groupRoleWhat they receive
Cohort 1 (4-week boost vaccination)Active comparator(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
Receives: Biological: VXA-G1.1-NN
Cohort 2 (8-week boost vaccination)Active comparator(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
Receives: Biological: VXA-G1.1-NN
Cohort 3 (12-week boost vaccination)Active comparator(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
Receives: Biological: VXA-G1.1-NN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Viral-capsid Protein 1 (VP1)-Specific Antibody Secreting Cells (ASC) by Enzyme-linked Immunospot (ELISpot) Assay

    Comparison of VPI specific immunoglobin A (IgA) ASC levels between the 3 study cohorts by enzyme-linked immunospot (ELISpot) assay

    Measured: Day 1 (Initial Vaccination) through Day 8 post boost (Second Vaccination)

  2. Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay

    Comparison of subjects with a ≥2-, 3- or 4-fold increase over baseline titer of GI.1 histo-blood group antigen (HBGA) blocking antibodies (BT50) levels between the 3 study cohorts.

    Measured: Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)

  3. VP1 Serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) Assay

    Comparison of VPI specific immunoglobin A (IgA) ASC levels by Mesoscale Discovery (MSD) assay between the 3 study cohorts

    Measured: Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)

  4. Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay

    Comparison of GI.1 histo-blood group antigen (HBGA) blocking antibodies (BT50) levels between the 3 study cohorts

    Measured: Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)

Secondary outcomes (1)

  1. Solicited Symptoms of Reactogenicity

    Comparison of frequency, duration, and severity of solicited symptom events in participants

    Measured: Day 1 (Vaccination) to Day 8 post each vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start30 Apr 2021
  3. Primary completion30 Oct 2021
  4. Study completion16 Feb 2022

Resources

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 1/2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875676
Sponsor's protocol ID
VXA-NVV-105
Acronym
VXA-NVV-105
Status last verified
May 2024
First submitted
19 Apr 2021
Last updated
22 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VXA-G1.1-NN in people with Norovirus Infections, 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 18 inclusion and 36 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 22 May 2024. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Viral-capsid Protein 1 (VP1)-Specific Antibody Secreting Cells (ASC) by Enzyme-linked Immunospot (ELISpot) Assay (time frame: Day 1 (Initial Vaccination) through Day 8 post boost (Second Vaccination)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04875676.

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 22 May 2024.

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