Seasonal Influenza BPhase 1NCT02547792
Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults
A Phase 1 study testing VXA-BYW.10 (Low Dose) Oral Vaccine and VXA-BYW.10 (High Dose) Oral Vaccine in people with Seasonal Influenza B, run by Vaxart at 1 site in New Zealand.
Trial summary
This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza B tested at two dose levels (low and high dose). Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza B
- What is being tested?
- VXA-BYW.10 (Low Dose) Oral Vaccine and VXA-BYW.10 (High Dose) Oral Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteNew Zealand
- Study dates
- 20 Oct 2015to 21 Nov 2016
- 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
- In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.
Who cannot join
- Positive for B influenza by HAI.
- Has had an influenza vaccine in the past 2 years.
- Current history of chronic alcohol use and/or illicit and/or recreational drug use.
- History of any confirmed or suspected immunodeficient or immunosuppressive condition
- Positive serology for HIV, HCV, or HBV
- Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
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- History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution of the vaccine targeting the mucosa of the small intestine
- Use of proton pump inhibitors(Nexium, Prilosec).
- Stool sample with occult blood at baseline exam
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 , Placebo-Controlled, Dose-Ranging Trial to Determine Safety and Immunogenicity of an Oral Adenoviral-Vector Based Influenza B Vaccine
This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27 subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated through 1 year post vaccination.
Read the detailed description
The study will enroll 54 subjects in four cohorts. All subjects will receive a single administration of VXA-BYW.10 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-BYW.10 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: 16 subjects at low dose and 8 placebo; Cohort 3: 3 subjects at high dose; Cohort 4: 16 subjects at low dose and 8 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
- Seasonal Influenza B
- Being tested
- VXA-BYW.10 (Low Dose) Oral Vaccine, VXA-BYW.10 (High Dose) Oral Vaccine, Placebo Tablets
- Keywords
- Influenza B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VXA-BYW.10 (Low Dose) Oral VaccineBiological
Also called Influenza B (Low Dose) Oral Vaccine Tablets
Enteric coated tablet for oral delivery
VXA-BYW.10 (High Dose) Oral VaccineBiological
Also called Influenza B (High Dose) Oral Vaccine Tablets
Enteric coated tablet for oral delivery
Placebo TabletsOther
Enteric coated tablet for oral delivery
| Study group | Role | What they receive |
|---|---|---|
| VXA-BYW.10 (Low Dose) Oral Vaccine | Experimental | Single administration of Influenza B (Low Dose) oral vaccine tablets Receives: Biological: VXA-BYW.10 (Low Dose) Oral Vaccine |
| VXA-BYW.10 (High Dose) Oral Vaccine | Experimental | Single administration of Influenza B (High Dose) oral vaccine tablets Receives: Biological: VXA-BYW.10 (High Dose) Oral Vaccine |
| Placebo Tablets | Placebo comparator | Matching placebo dose (size and number of tablets) to low dose vaccine (part 1) and high dose (part 2) Receives: Other: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Single High Dose of an Oral Influenza B Tablet Vaccine
Safety determined by reported solicited (reactogenicity) and unsolicited AEs.
Measured: Day 28
Secondary outcomes (1)
Immunogenicity of Single high Dose of an Oral Influenza B Tablet Vaccine
Efficacy determined by HAI titers at Day 28 post-vaccination
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start20 Oct 2015
- Primary completion21 Nov 2016
- Study completion21 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Influenza BStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Liebowitz, MD, PhD, Study director, Vaxart, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547792
- Sponsor's protocol ID
- VXA03-001
- Status last verified
- May 2018
- First submitted
- 9 Sep 2015
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
- Phase 1 , Placebo-Controlled, Dose-Ranging Trial to Determine Safety and Immunogenicity of an Oral Adenoviral-Vector Based Influenza B Vaccine
- ClinicalTrials.gov ID
- NCT02547792
- Acronym / sponsor ID
- VXA03-001
- Conditions
- Seasonal Influenza B
- Keywords
- Influenza B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 21 Nov 2016 (actual)
- First posted
- 11 Sep 2015 (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.
This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27 subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated through 1 year post vaccination.
Detailed description
The study will enroll 54 subjects in four cohorts. All subjects will receive a single administration of VXA-BYW.10 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-BYW.10 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: 16 subjects at low dose and 8 placebo; Cohort 3: 3 subjects at high dose; Cohort 4: 16 subjects at low dose and 8 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
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VXA-BYW.10 (Low Dose) Oral Vaccine | Experimental | Biological: VXA-BYW.10 (Low Dose) Oral VaccineSingle administration of Influenza B (Low Dose) oral vaccine tablets |
| VXA-BYW.10 (High Dose) Oral Vaccine | Experimental | Biological: VXA-BYW.10 (High Dose) Oral VaccineSingle administration of Influenza B (High Dose) oral vaccine tablets |
| Placebo Tablets | Placebo comparator | Other: Placebo TabletsMatching placebo dose (size and number of tablets) to low dose vaccine (part 1) and high dose (part 2) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.
Key exclusion criteria (10 listed)
- Positive for B influenza by HAI.
- Has had an influenza vaccine in the past 2 years.
- Current history of chronic alcohol use and/or illicit and/or recreational drug use.
- History of any confirmed or suspected immunodeficient or immunosuppressive condition
- Positive serology for HIV, HCV, or HBV
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-BYW.10 (Low Dose) Oral VaccineAlso: Influenza B (Low Dose) Oral Vaccine TabletsEnteric coated tablet for oral delivery | Biological | VXA-BYW.10 (Low Dose) Oral Vaccine |
| VXA-BYW.10 (High Dose) Oral VaccineAlso: Influenza B (High Dose) Oral Vaccine TabletsEnteric coated tablet for oral delivery | Biological | VXA-BYW.10 (High Dose) Oral Vaccine |
| Placebo TabletsEnteric coated tablet for oral delivery | Other | Placebo Tablets |
Primary outcome
Safety and Tolerability of Single High Dose of an Oral Influenza B Tablet Vaccine
Time frame: Day 28
Safety determined by reported solicited (reactogenicity) and unsolicited AEs.
1 secondary outcome
Immunogenicity of Single high Dose of an Oral Influenza B Tablet Vaccine
Time frame: Day 28
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.
- Individual participant dataSharing planned: No
Related trials for Seasonal Influenza B
Active, not recruitingPhase 4
B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults
Influenza
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.
David Liebowitz, MD, PhD 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-BYW.10 (Low Dose) Oral Vaccine and VXA-BYW.10 (High Dose) Oral Vaccine in people with Seasonal Influenza B, run by Vaxart at 1 site in New Zealand.
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 1 inclusion and 10 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 New Zealand. 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?
Safety and Tolerability of Single High Dose of an Oral Influenza B Tablet Vaccine (time frame: Day 28). 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 31 May 2018.