Avian InfluenzaPhase 1H5N1NCT01335347
Safety Study of an Oral Vaccine to Prevent Avian Influenza
A Phase 1 study testing ND1.1 in people with Avian Influenza and Bird Flu, run by Vaxart at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Avian Influenza, Bird Flu
- What is being tested?
- ND1.1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2012
- 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
- Has had any other vaccines within the past 8 weeks.
- Has had prior H5 avian influenza investigational vaccine.
- Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
- History of autoimmune related disease.
- History of any confirmed or suspected immunodeficient or immunosuppressive condition (no congenital or acquired condition that impedes normal immune response, no concurrent immunosuppressive therapy).
- Positive serology for HIV, HCV, or HBV.
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- Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain.
- History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution or safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine.
- Use of proton pump inhibitors (Nexium, Prilosec) that substantially increases stomach pH.
- Stool sample with occult blood at baseline exam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Escalation Phase 1 Safety and Immunogenicity Study of an Oral Viral Vector Vaccine Encoding Avian Influenza H5N1 Hemagglutinin Protein and dsRNA Adjuvant in Healthy Adults
The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study.
- Conditions
- Avian Influenza, Bird Flu
- Being tested
- ND1.1, Placebo control
- Keywords
- Influenza, pandemic, avian influenza, H5N1, flu
- Medical subject headings
- Influenza in Birds, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND1.1Biological
Also called Ad-HA-dsRNA
adenovirus with the dsRNA adjuvant, dried and put into capsules
Placebo controlBiological
Capsules of the same size and shape as experimental groups
| Study group | Role | What they receive |
|---|---|---|
| Experimental Low Dose | Experimental | Biological: One dose of a live replication incompetent adenovirus given in a capsule Receives: Biological: ND1.1 |
| Experimental Medium Dose | Experimental | Biological: One or two doses of replication incompetent adenovirus given in a capsule
Other: Placebo capsules of the same size and shape Receives: Biological: ND1.1 |
| Experimental High Dose | Experimental | Biological: One dose of replication incompetent adenovirus in a capsule Receives: Biological: ND1.1 |
| Placebo Control | Placebo comparator | Capsules of the same size and shape as the experimental Receives: Biological: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency or severity of vaccine related events as measured through reported AEs
Measured: up to 1 year
Secondary outcomes (2)
Magnitude of humoral immune responses to avian influenza as measured by functional assays
Measured: up to 1 year
Magnitude of cellular immune responses to avian influenza as measured by functional assays
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionSep 2012
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 Avian 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean N Tucker, PhD, Study director, VaxartMartin Kabongo, MD, PhD, Principal investigator, Accelovance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335347
- Sponsor's protocol ID
- VXA01-001
- Acronym
- H5N1
- Status last verified
- Jan 2013
- First submitted
- 10 Apr 2011
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Peters W, Brandl JR, Lindbloom JD, Martinez CJ, Scallan CD, Trager GR, Tingley DW, Kabongo ML, Tucker SN. Oral administration of an adenovirus vector encoding both an avian influenza A hemagglutinin and a TLR3 ligand induces antigen specific granzyme B and IFN-gamma T cell responses in humans. Vaccine. 2013 Mar 25;31(13):1752-8. doi: 10.1016/j.vaccine.2013.01.023. Epub 2013 Jan 25.
PubMed 23357198
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Phase 1 Safety and Immunogenicity Study of an Oral Viral Vector Vaccine Encoding Avian Influenza H5N1 Hemagglutinin Protein and dsRNA Adjuvant in Healthy Adults
- ClinicalTrials.gov ID
- NCT01335347
- Acronym / sponsor ID
- H5N1 / VXA01-001
- Conditions
- Avian Influenza, Bird Flu
- Keywords
- Influenza, pandemic, avian influenza, H5N1, flu
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Apr 2011 (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 is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study.
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 |
|---|---|---|
| Experimental Low Dose | Experimental | Biological: ND1.1Biological: One dose of a live replication incompetent adenovirus given in a capsule |
| Experimental Medium Dose | Experimental | Biological: ND1.1Biological: One or two doses of replication incompetent adenovirus given in a capsule Other: Placebo capsules of the same size and shape |
| Experimental High Dose | Experimental | Biological: ND1.1Biological: One dose of replication incompetent adenovirus in a capsule |
| Placebo Control | Placebo comparator | Biological: Placebo controlCapsules of the same size and shape as the experimental |
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)
- Has had any other vaccines within the past 8 weeks.
- Has had prior H5 avian influenza investigational vaccine.
- Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
- History of autoimmune related disease.
- History of any confirmed or suspected immunodeficient or immunosuppressive condition (no congenital or acquired condition that impedes normal immune response, no concurrent immunosuppressive therapy).
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 |
|---|---|---|
| ND1.1Also: Ad-HA-dsRNAadenovirus with the dsRNA adjuvant, dried and put into capsules | Biological | Experimental High Dose, Experimental Low Dose, Experimental Medium Dose |
| Placebo controlCapsules of the same size and shape as experimental groups | Biological | Placebo Control |
Primary outcome
Frequency or severity of vaccine related events as measured through reported AEs
Time frame: up to 1 year
2 secondary outcomes
Magnitude of humoral immune responses to avian influenza as measured by functional assays
Time frame: up to 1 year
Magnitude of cellular immune responses to avian influenza as measured by functional assays
Time frame: up to 1 year
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 3 Jan 2013.
- Derived from this study: PubMed 23357198Peters W, Brandl JR, Lindbloom JD, Martinez CJ, Scallan CD, Trager GR, Tingley DW, Kabongo ML, Tucker SN. Oral administration of an adenovirus vector encoding both an avian influenza A hemagglutinin and a TLR3 ligand induces antigen specific granzyme B and IFN-gamma T cell responses in humans. Vaccine. 2013 Mar 25;31(13):1752-8. doi: 10.1016/j.vaccine.2013.01.023. Epub 2013 Jan 25.
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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.
Sean N Tucker, PhD study director
Vaxart
Martin Kabongo, MD, PhD principal investigator
Accelovance
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 ND1.1 in people with Avian Influenza and Bird Flu, 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 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 3 Jan 2013. 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?
Frequency or severity of vaccine related events as measured through reported AEs (time frame: up to 1 year). 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 NCT01335347, 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 3 Jan 2013.