Norovirus InfectionsPhase 1(VXA-G1-1-NN)NCT05213728
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
A Phase 1 study testing VXA-G1.1-NN in people with Norovirus Infections, run by Vaxart at 1 site in United States.
Trial 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. 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
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 24 Feb 2022
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 12Show fewer
- At least 1 year post-menopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without alternative medical cause)
- 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)
- Male participants must agree not to father a child or donate sperm, as well as to use contraception/barrier (a male condom) or be abstinent from heterosexual intercourse during the study active period (Day 29)
Who cannot join
- 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 Norwalk GI.1 (VXA-G1.1-NN) Protocol No. VXA-NVV-106
- Version 1.2 Confidential Page 11 of 42 Date: 04 Jan 2022
- Such conditions may include but are not limited to:
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- 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
- Laboratory values outside the range of normal for platelet counts and the following coagulation tests: PT/INR, aPTT and fibrinogen
- Any of the following history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:
- Family or personal history of bleeding or thrombosis
- History of heparin-related thrombotic events, and/or receiving heparin treatments
- History of autoimmune or inflammatory disease
- Presence of any of the following conditions known to increase risk of thrombosis within 6 months prior to screening:
- Recent surgery other than removal/biopsy of cutaneous lesions
- Immobility (confined to bed or wheelchair for 3 or more successive days)
- Head trauma with loss of consciousness or documented brain injury
- Receipt of anticoagulants for prophylaxis of thrombosis
- Recent clinically significant infection
- Any significant hospitalization within the last year which in the opinion of Norwalk GI.1 (VXA-G1.1-NN) Protocol No. VXA-NVV-106
- 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
- Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) tests at screening visit
- Positive urine drug screen for drugs of abuse at screening
- Positive breath or urine alcohol test at screening and baseline
- Receipt of a licensed vaccine within 14 days prior to baseline vaccination or planned administration during the study active period
- 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 vaccination or planned use during the active period
- Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study vaccination or planned use during the active study period
- Administration of any investigational vaccine, drug or device within 8 weeks preceding study vaccination (Day 1), or planned use within the duration of the study
- Donation or use of blood or blood products within 30 days prior to study vaccination 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.
About this study
Official title: 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) Expressing GI.1 VP1 Administered to Healthy Adult Volunteers
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.
Read the detailed description
Primary Objective
- To determine the immunogenicity of the VXA-G1.1-NN oral vaccine administered via multiple sub-doses over a 4-hour period to deliver a total dose of 1E11 IU ±0.5 log Secondary Objectives
- To determine the safety and tolerability of the VXA-G1.1-NN oral vaccine administered via multiple sub-doses over a 4-hour period to deliver a total dose of 1E11 IU ±0.5 log
This is an open-label study in healthy adult participants aged 18-55 years old. The study will enroll 8 subjects to a single treatment cohort, all of whom will receive a single 1E11 IU± 0.5 log at Day 1. This dose will be administered in a step wise manner over 4 hours with 1/3 of the dose administered at T=0, 1/3 of the dose administered at T= 2 hours and 1/3 of the dose administered at T=4 hours.
The study will include a Screening Period, Active Period (Day 1 to Day 29, 4 weeks post vaccination) and a Safety Follow-up Period through 12 months post vaccination (Day 365). In addition, participants will be contacted by phone during the Safety Follow-up Period to assess for Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs).
After signing an informed consent, participants will undergo screening assessments to determine study eligibility within a 30-day screening period. Eligible participants will be enrolled and receive their first dose of study vaccine on Day 1.
During the Active Period, participants will record any potential solicited symptoms of reactogenicity daily for 1 week post study vaccination. Participants will return to the site as specified in the Schedule of Activities to have safety assessments and samples collected for evaluation of immunogenicity. Approximately 8 subjects will be vaccinated in the active phase.
The following study visits and remote contacts will be conducted during the study:
Active Period:
- Screening Period (Days -30 to -1)
- Day 1 Visit (Baseline assessments, vaccination, sample collection)
- Day 8 Visit (Safety assessments, sample collection)
- Day 29 End of Active Period; (Safety assessments, sample collection)
Safety Follow-Up Period:
- Day 180 (follow-up phone call for safety)
- Day 365 (follow-up phone call for safety): Study completion
- Conditions
- Norovirus Infections
- 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
Also called Oral Tableted Ad5 Norovirus GI.1 Vaccine
Norovirus GI.1 Norwalk VP1 Vaccine (VXA-G1.1-NN) E1/E3-Deleted Replication-Defective Recombinant Adenovirus 5 with Adjuvant Oral Tablet Vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single 1E11 dose administered via multiple sub-doses over a 4-hour period in adults (18-55 yrs). Receives: Biological: VXA-G1.1-NN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Solicited Symptoms of Reactogenicity
To assess the safety and tolerability of an oral tableted vaccine by collection of solicited symptoms of vaccine reactogenicity recorded daily using a subject diary card for 1 week post initial vaccination at Day 1.
Measured: Up to Day 8
To assess the induction of VP1-specific Immunoglobin A (IgA) antibody-secreting cells (ASC) by ELISpot assay
Change from baseline in VP1-specific Immunogolobin A (IgA) antibody-secreting cells (ASC) by ELISpot assay will be evaluated at Day 8
Measured: Change from baseline at Day 8
To assess histo-blood group antigen (HBGA) blocking antibodies by blockade titer (BT50)
Change from baseline in histo-blood group antigen (HBGA) blocking antibodies evaluated at Day 29
Measured: Change from baseline at Day 29
To assess VP1-specific serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay
Change from baseline in VP1-specific Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay will be evaluated at Day 29
Measured: Change from baseline at Day 29
To assess the VP1-specific serum Immunoglobin A (IgA) by Mesoscale Discovery (MSD) assay
Change from baseline in VP1-specific serum IgG by Mesoscale Discovery (MSD) will be evaluated at Day 29
Measured: Change from baseline at Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start24 Jan 2022
- Primary completion1 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Norovirus InfectionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Cummings, MD, Study director, Vaxart, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213728
- Sponsor's protocol ID
- VXA-NVV-106
- Acronym
- (VXA-G1-1-NN)
- Status last verified
- Sep 2022
- First submitted
- 18 Jan 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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) Expressing GI.1 VP1 Administered to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05213728
- Acronym / sponsor ID
- (VXA-G1-1-NN) / VXA-NVV-106
- Conditions
- Norovirus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 28 Jan 2022 (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.
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.
Detailed description
Primary Objective
- To determine the immunogenicity of the VXA-G1.1-NN oral vaccine administered via multiple sub-doses over a 4-hour period to deliver a total dose of 1E11 IU ±0.5 log Secondary Objectives
- To determine the safety and tolerability of the VXA-G1.1-NN oral vaccine administered via multiple sub-doses over a 4-hour period to deliver a total dose of 1E11 IU ±0.5 log
This is an open-label study in healthy adult participants aged 18-55 years old. The study will enroll 8 subjects to a single treatment cohort, all of whom will receive a single 1E11 IU± 0.5 log at Day 1. This dose will be administered in a step wise manner over 4 hours with 1/3 of the dose administered at T=0, 1/3 of the dose administered at T= 2 hours and 1/3 of the dose administered at T=4 hours.
The study will include a Screening Period, Active Period (Day 1 to Day 29, 4 weeks post vaccination) and a Safety Follow-up Period through 12 months post vaccination (Day 365). In addition, participants will be contacted by phone during the Safety Follow-up Period to assess for Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs).
After signing an informed consent, participants will undergo screening assessments to determine study eligibility within a 30-day screening period. Eligible participants will be enrolled and receive their first dose of study vaccine on Day 1.
During the Active Period, participants will record any potential solicited symptoms of reactogenicity daily for 1 week post study vaccination. Participants will return to the site as specified in the Schedule of Activities to have safety assessments and samples collected for evaluation of immunogenicity. Approximately 8 subjects will be vaccinated in the active phase.
The following study visits and remote contacts will be conducted during the study:
Active Period:
- Screening Period (Days -30 to -1)
- Day 1 Visit (Baseline assessments, vaccination, sample collection)
- Day 8 Visit (Safety assessments, sample collection)
- Day 29 End of Active Period; (Safety assessments, sample collection)
Safety Follow-Up Period:
- Day 180 (follow-up phone call for safety)
- Day 365 (follow-up phone call for safety): Study completion
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: VXA-G1.1-NNSingle 1E11 dose administered via multiple sub-doses over a 4-hour period in adults (18-55 yrs). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (46 listed)
- 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 Norwalk GI.1 (VXA-G1.1-NN) Protocol No. VXA-NVV-106
- Version 1.2 Confidential Page 11 of 42 Date: 04 Jan 2022
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-NNAlso: Oral Tableted Ad5 Norovirus GI.1 VaccineNorovirus GI.1 Norwalk VP1 Vaccine (VXA-G1.1-NN) E1/E3-Deleted Replication-Defective Recombinant Adenovirus 5 with Adjuvant Oral Tablet Vaccine. | Biological | Cohort 1 |
Primary outcome
Rate of Solicited Symptoms of Reactogenicity
Time frame: Up to Day 8
To assess the safety and tolerability of an oral tableted vaccine by collection of solicited symptoms of vaccine reactogenicity recorded daily using a subject diary card for 1 week post initial vaccination at Day 1.
To assess the induction of VP1-specific Immunoglobin A (IgA) antibody-secreting cells (ASC) by ELISpot assay
Time frame: Change from baseline at Day 8
Change from baseline in VP1-specific Immunogolobin A (IgA) antibody-secreting cells (ASC) by ELISpot assay will be evaluated at Day 8
To assess histo-blood group antigen (HBGA) blocking antibodies by blockade titer (BT50)
Time frame: Change from baseline at Day 29
Change from baseline in histo-blood group antigen (HBGA) blocking antibodies evaluated at Day 29
To assess VP1-specific serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay
Time frame: Change from baseline at Day 29
Change from baseline in VP1-specific Immunoglobin G (IgG) by Mesoscale Discovery (MSD) assay will be evaluated at Day 29
To assess the VP1-specific serum Immunoglobin A (IgA) by Mesoscale Discovery (MSD) assay
Time frame: Change from baseline at Day 29
Change from baseline in VP1-specific serum IgG by Mesoscale Discovery (MSD) will be evaluated at Day 29
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 21 Jun 2024.
- Individual participant dataSharing planned: No
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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.
James Cummings, MD study director
Vaxart, Inc.
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 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 12 inclusion and 46 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 21 Jun 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 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?
Rate of Solicited Symptoms of Reactogenicity (time frame: Up to Day 8). The study lists 5 primary outcomes in all. 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 21 Jun 2024.