Norovirus InfectionPhase 1NCT03721549
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
A Phase 1 study testing Norwalk GI.1 Virus in people with Norovirus Infection, run by WCCT Global at 1 site in United States.
Trial summary
There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Norovirus Infection
- What is being tested?
- Norwalk GI.1 Virus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2018to 28 Nov 2018
- Phase
- Phase 1
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General good health, without significant 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
- Available for all planned visits and to spend at least 5 days in confinement
- Confirmed blood type (A or O)
- Demonstrated to be H type-1 antigen secretor positive (by saliva test)
- Body mass index between 17 and 30 at screening
- Female subjects must have a negative pregnancy test and either use contraceptives or be sterile
- Available to return for follow-up visits following discharge from the inpatient unit and deliver stool specimens to the investigator promptly
Who cannot join
- Presence of significant medical condition
- Donation or use of blood or blood products within 4 weeks prior to challenge
- Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic
- Abnormal stool pattern
- Any gastroenteritis within the past 2 weeks
- Occupational hazards, including having daily contact with children under the age of 5, women known to be pregnant, employment in the food service industry, health care workers, etc.
Trial locations and contacts
1 site in 1 country.
About this study
There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine studies.
- Conditions
- Norovirus Infection
- Being tested
- Norwalk GI.1 Virus
- Medical subject headings
- Caliciviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norwalk GI.1 VirusBiological
Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Dose Inoculum | Experimental | Moderate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies Receives: Biological: Norwalk GI.1 Virus |
| Higher Dose Inoculum | Experimental | Higher dose of Norwalk GI.1 Virus, 1x10^6 genome copies Receives: Biological: Norwalk GI.1 Virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Norovirus Gastroenteritis (NVG)
Occurrence of NVG within 7 days post-challenge
Measured: 7 days post-challenge
Secondary outcomes (1)
Frequency of Serious Adverse Events (SAEs)
Occurrence of SAEs
Measured: 42 ± 3 days post-challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start3 Oct 2018
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Norovirus InfectionStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- WCCT Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vaxart
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721549
- Sponsor's protocol ID
- VXA-G11-201.1
- Status last verified
- Jan 2020
- First submitted
- 24 Oct 2018
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
- ClinicalTrials.gov ID
- NCT03721549
- Acronym / sponsor ID
- VXA-G11-201.1
- Conditions
- Norovirus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- WCCT GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Vaxart
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine studies.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum
| Arm | Type | Receives |
|---|---|---|
| Moderate Dose Inoculum | Experimental | Biological: Norwalk GI.1 VirusModerate dose of Norwalk GI.1 Virus, 3.6x10^5 genome copies |
| Higher Dose Inoculum | Experimental | Biological: Norwalk GI.1 VirusHigher dose of Norwalk GI.1 Virus, 1x10^6 genome copies |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- General good health, without significant 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
- Available for all planned visits and to spend at least 5 days in confinement
- Confirmed blood type (A or O)
- Demonstrated to be H type-1 antigen secretor positive (by saliva test)
- Body mass index between 17 and 30 at screening
Key exclusion criteria (6 listed)
- Presence of significant medical condition
- Donation or use of blood or blood products within 4 weeks prior to challenge
- Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic
- Abnormal stool pattern
- Any gastroenteritis within the past 2 weeks
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 |
|---|---|---|
| Norwalk GI.1 VirusNorwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu. | Biological | Higher Dose Inoculum, Moderate Dose Inoculum |
Primary outcome
Frequency of Norovirus Gastroenteritis (NVG)
Time frame: 7 days post-challenge
Occurrence of NVG within 7 days post-challenge
1 secondary outcome
Frequency of Serious Adverse Events (SAEs)
Time frame: 42 ± 3 days post-challenge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Norwalk GI.1 Virus in people with Norovirus Infection, run by WCCT Global 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 7 inclusion and 6 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 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2020). 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?
Frequency of Norovirus Gastroenteritis (NVG) (time frame: 7 days post-challenge). 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 22 Jan 2020.