InfluenzaPhase 1NCT01688297
Safety Study of an Oral Vaccine to Prevent Seasonal Influenza
A Phase 1 study testing VXA-A1.1 Oral Vaccine in people with Influenza, run by Vaxart at 1 site in United States.
Trial summary
The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VXA-A1.1 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
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Apr 2015
- 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 H1 influenza by HAI.
- Has had an influenza vaccine in the past 2 years.
- Current history of chronic alcohol consumption 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase 1 Double-Blinded Placebo Controlled Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Seasonal Influenza A Vaccine and dsRNA Adjuvant Administered Orally to Healthy Volunteers
The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).
Read the detailed description
Low and mid dose study was conducted under protocol number VXA02-001
High dose study was conducted under protocol number VXA02-003
- Conditions
- Influenza
- Being tested
- VXA-A1.1 Oral Vaccine, VXA Placebo Tablet
- Keywords
- Influenza, H1N1, flu, seasonal
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VXA-A1.1 Oral VaccineBiological
Also called Ad-HA-dsRNA (VXA-A1.1)
One or two doses of replication incompetent adenovirus oral tablet vaccine
VXA Placebo TabletBiological
Also called Placebo Control
Off-white tablets similarly formulated to the active drug product tablets.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose VXA-A1.1 Oral Vaccine | Experimental | Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation. Receives: Biological: VXA-A1.1 Oral Vaccine |
| VXA Placebo Tablet | Placebo comparator | Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design. Receives: Biological: VXA Placebo Tablet |
| Medium Dose VXA-A1.1 Oral Vaccine | Experimental | Two doses of replication incompetent adenovirus vaccine given in an oral tablet Receives: Biological: VXA-A1.1 Oral Vaccine |
| High Dose VXA-A1.1 Oral Vaccine | Experimental | One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003. Receives: Biological: VXA-A1.1 Oral Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events
Measured: One year following last vaccination
Secondary outcomes (2)
Magnitude of humoral immune response to influenza as measured by functional assays
Measured: 28 Days and 180 Days post-vaccination
Magnitude of cellular immune responses to influenza as measured by functional assays
Measured: 28 Days and 180 Days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionApr 2015
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 InfluenzaStudies 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
- 61 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.Apinya Vutikullird, DO, Principal investigator, WCCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688297
- Sponsor's protocol ID
- VXA02-001 & VXA02-003
- Status last verified
- May 2017
- First submitted
- 14 Sep 2012
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liebowitz D, Lindbloom JD, Brandl JR, Garg SJ, Tucker SN. High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial. Lancet Infect Dis. 2015 Sep;15(9):1041-1048. doi: 10.1016/S1473-3099(15)00266-2.
PubMed 26333337
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 1 Double-Blinded Placebo Controlled Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Seasonal Influenza A Vaccine and dsRNA Adjuvant Administered Orally to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01688297
- Acronym / sponsor ID
- VXA02-001 & VXA02-003
- Conditions
- Influenza
- Keywords
- Influenza, H1N1, flu, seasonal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Sep 2012 (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.
The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).
Detailed description
Low and mid dose study was conducted under protocol number VXA02-001
High dose study was conducted under protocol number VXA02-003
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose VXA-A1.1 Oral Vaccine | Experimental | Biological: VXA-A1.1 Oral VaccineTwo doses of replication incompetent adenovirus vaccine given in an oral tablet formulation. |
| VXA Placebo Tablet | Placebo comparator | Biological: VXA Placebo TabletOral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design. |
| Medium Dose VXA-A1.1 Oral Vaccine | Experimental | Biological: VXA-A1.1 Oral VaccineTwo doses of replication incompetent adenovirus vaccine given in an oral tablet |
| High Dose VXA-A1.1 Oral Vaccine | Experimental | Biological: VXA-A1.1 Oral VaccineOne dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003. |
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 (9 listed)
- Positive for H1 influenza by HAI.
- Has had an influenza vaccine in the past 2 years.
- Current history of chronic alcohol consumption 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-A1.1 Oral VaccineAlso: Ad-HA-dsRNA (VXA-A1.1)One or two doses of replication incompetent adenovirus oral tablet vaccine | Biological | High Dose VXA-A1.1 Oral Vaccine, Low Dose VXA-A1.1 Oral Vaccine, Medium Dose VXA-A1.1 Oral Vaccine |
| VXA Placebo TabletAlso: Placebo ControlOff-white tablets similarly formulated to the active drug product tablets. | Biological | VXA Placebo Tablet |
Primary outcome
Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events
Time frame: One year following last vaccination
2 secondary outcomes
Magnitude of humoral immune response to influenza as measured by functional assays
Time frame: 28 Days and 180 Days post-vaccination
Magnitude of cellular immune responses to influenza as measured by functional assays
Time frame: 28 Days and 180 Days 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 12 May 2017.
- Results publication: PubMed 26333337Liebowitz D, Lindbloom JD, Brandl JR, Garg SJ, Tucker SN. High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial. Lancet Infect Dis. 2015 Sep;15(9):1041-1048. doi: 10.1016/S1473-3099(15)00266-2.
- 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.
David Liebowitz, MD, PhD study director
Vaxart, Inc.
Apinya Vutikullird, DO principal investigator
WCCT
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-A1.1 Oral Vaccine in people with Influenza, 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 1 inclusion and 9 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 12 May 2017. 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?
Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events (time frame: One year following last vaccination). 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 NCT01688297, 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 12 May 2017.