Norovirus GastroenteritisPhase 1NCT02868073
Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine
A Phase 1 study testing VXA-G1.1-NN (high dose) Oral Vaccine Tablet and VXA-G1.1-NN (low dose) Oral Vaccine Tablet in people with Norovirus Gastroenteritis, run by Vaxart at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Norovirus Gastroenteritis
- What is being tested?
- VXA-G1.1-NN (high dose) Oral Vaccine Tablet and VXA-G1.1-NN (low dose) Oral Vaccine Tablet
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2016to 1 Oct 2017
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female volunteers aged 18 - 49 years, inclusive
- Able to give written informed consent
- Healthy (no clinically significant health concerns)
- Safety laboratory values within the following range criteria normal range
- Body mass index between 17 and 35 at screening
Who cannot join
- Receipt of any investigational norovirus vaccine within two years prior to study
- Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination
- Administration of any licensed vaccine within 30 days prior to study
- 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
- History of drug, alcohol or chemical abuse within 1 year prior to vaccination
- Presence of a fever ≥ 38oC measured orally at baseline
- Stool sample with occult blood at screening -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the 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.
- Conditions
- Norovirus Gastroenteritis
- Being tested
- VXA-G1.1-NN (high dose) Oral Vaccine Tablet, VXA Placebo Tablets, VXA-G1.1-NN (low dose) Oral Vaccine Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VXA-G1.1-NN (high dose) Oral Vaccine TabletBiological
Also called H1N1 (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.
VXA Placebo TabletsOther
Also called Placebo Control
The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.
VXA-G1.1-NN (low dose) Oral Vaccine TabletBiological
Also called H1N1 (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.
| Study group | Role | What they receive |
|---|---|---|
| H1N1 (high dose) Oral Vaccine Tablet | Experimental | Singe dose of orally administered VXA-G1.1-NN (high dose) Oral Vaccine Tablet. 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. Receives: Biological: VXA-G1.1-NN (high dose) Oral Vaccine Tablet |
| H1N1 (low dose) Oral Vaccine Tablet | Experimental | Singe dose of orally administered VXA-G1.1-NN (low dose) Oral Vaccine Tablet. 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. Receives: Biological: VXA-G1.1-NN (low dose) Oral Vaccine Tablet |
| Placebo Tablets | Placebo comparator | Singe dose of VXA Placebo tablets. The placebo tablets are small off-white tablets that are similar in size and number to the active vaccine dose being delivered. Receives: Other: VXA Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Solicited and Unsolicited Adverse Events
Solicited Symptoms of Reactogenicity (thru Day 8); unsolicited Adverse Events thru Day 28 post vaccination
Measured: Day 1 thru Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start29 Jul 2016
- Primary completion5 Oct 2016
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Sterling, MD, PhD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868073
- Sponsor's protocol ID
- VXA-G11-101
- Status last verified
- May 2018
- First submitted
- 11 Aug 2016
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim L, Liebowitz D, Lin K, Kasparek K, Pasetti MF, Garg SJ, Gottlieb K, Trager G, Tucker SN. Safety and immunogenicity of an oral tablet norovirus vaccine, a phase I randomized, placebo-controlled trial. JCI Insight. 2018 Jul 12;3(13):e121077. doi: 10.1172/jci.insight.121077.
PubMed 29997294
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02868073
- Acronym / sponsor ID
- VXA-G11-101
- Conditions
- Norovirus Gastroenteritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2016 (actual)
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| H1N1 (high dose) Oral Vaccine Tablet | Experimental | Biological: VXA-G1.1-NN (high dose) Oral Vaccine TabletSinge dose of orally administered VXA-G1.1-NN (high dose) Oral Vaccine Tablet. 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. |
| H1N1 (low dose) Oral Vaccine Tablet | Experimental | Biological: VXA-G1.1-NN (low dose) Oral Vaccine TabletSinge dose of orally administered VXA-G1.1-NN (low dose) Oral Vaccine Tablet. 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. |
| Placebo Tablets | Placebo comparator | Other: VXA Placebo TabletsSinge dose of VXA Placebo tablets. The placebo tablets are small off-white tablets that are similar in size and number to the active vaccine dose being delivered. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female volunteers aged 18 - 49 years, inclusive
- Able to give written informed consent
- Healthy (no clinically significant health concerns)
- Safety laboratory values within the following range criteria normal range
- Body mass index between 17 and 35 at screening
Key exclusion criteria (7 listed)
- Receipt of any investigational norovirus vaccine within two years prior to study
- Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination
- Administration of any licensed vaccine within 30 days prior to study
- 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
- History of drug, alcohol or chemical abuse within 1 year 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 (high dose) Oral Vaccine TabletAlso: H1N1 (high dose) Oral Vaccine TabletThe drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high dose. | Biological | H1N1 (high dose) Oral Vaccine Tablet |
| VXA Placebo TabletsAlso: Placebo ControlThe placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets. | Other | Placebo Tablets |
| VXA-G1.1-NN (low dose) Oral Vaccine TabletAlso: H1N1 (low dose) Oral Vaccine TabletThe drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the low dose. | Biological | H1N1 (low dose) Oral Vaccine Tablet |
Primary outcome
Incidence of Treatment Emergent Solicited and Unsolicited Adverse Events
Time frame: Day 1 thru Day 28
Solicited Symptoms of Reactogenicity (thru Day 8); unsolicited Adverse Events thru Day 28 post vaccination
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 31 May 2018.
- Derived from this study: PubMed 29997294Kim L, Liebowitz D, Lin K, Kasparek K, Pasetti MF, Garg SJ, Gottlieb K, Trager G, Tucker SN. Safety and immunogenicity of an oral tablet norovirus vaccine, a phase I randomized, placebo-controlled trial. JCI Insight. 2018 Jul 12;3(13):e121077. doi: 10.1172/jci.insight.121077.
- Individual participant dataSharing planned: No
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, PhD 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 (high dose) Oral Vaccine Tablet and VXA-G1.1-NN (low dose) Oral Vaccine Tablet 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 5 inclusion and 7 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 31 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. Some participants in this study may receive a placebo. 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?
Incidence of Treatment Emergent Solicited and Unsolicited Adverse Events (time frame: Day 1 thru Day 28). 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 NCT02868073, which also lists 1 linked publication.
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 31 May 2018.