InfluenzaPhase 2NCT02918006
A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine
A Phase 2 study testing VXA-A1.1 and Fluzone® in people with Influenza, run by Vaxart at 1 site in United States.
Trial summary
A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers. 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 and Fluzone®
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2016to 19 Jan 2018
- Phase
- Phase 2
- 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
- Male or female volunteers aged 18 - 49 years, inclusive
- Able to give written informed consent
- Low pre-existing antibodies to the study vaccine
- In general good health (no clinically significant health concerns)
- Safety laboratory normal range or not clinically significant (NCS), with few exceptions
- Body mass index (BMI) between 17 and 35
- Comprehension of the study requirements with ability and willingness to complete all assessments and comply with scheduled visits and contacts
- Female participants must have a negative pregnancy test at screening
Who cannot join
- Receipt of any influenza vaccine within two years prior to study
- Use of any investigational vaccine/adjuvanted vaccine within 8 weeks of study
- Use of any investigational drug or device within 4 weeks of study
- Use of any licensed vaccine within 30 days of study
- Presence of significant uncontrolled medical or psychiatric illness within 3 months of study
- Clinically significant and/or protocol defined ECG abnormality
Show all 19Show fewer
- Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
- Cancer, or treatment for cancer, within 3 years of study
- History of drug, alcohol or chemical abuse within 1 year
- Receipt of blood or blood products within 6 months of study
- Donation of blood within 4 weeks of study
- Presence of a fever ≥ 38ºC measured orally at baseline
- Stool sample with occult blood at screening
- Positive urine drug screen for drugs of abuse at screening
- Positive breath or urine alcohol test at screening or baseline
- Consistent/habitual smoking within 2 months prior to vaccination
- History of serious reactions to any vaccination such as anaphylaxis, respiratory problems, Guillain-Barre syndrome, hives or abdominal pain
- Asthma, bronchiectasis or chronic obstructive pulmonary disease
- Any known allergy or intolerance to oseltamivir
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Randomized, Controlled, Human Influenza A (H1N1) Challenge Study Following Administration of an Oral H1N1 HA Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant to Healthy Adult Volunteers
A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.
Read the detailed description
This is a Phase 2 randomized, placebo- and active-controlled, two-part study in which healthy adult volunteers with low or undetectable pre-existing antibodies against A/California/7/2009(H1N1) pdm09-like virus will be challenged with an influenza A/H1N1 human challenge strain approximately 90 days after vaccination with a single dose of H1N1 HA Adenoviral-vector based seasonal influenza vaccine and dsRNA adjuvant (VXA-A1.1), an injectable QIV vaccine, and/or placebo.
An independent Safety Monitoring Committee (SMC) will oversee the safety of the study.
To accommodate the limited size of the isolation unit that will be utilized for the challenge and post-challenge sequestration period, subjects will move through the study (enrollment, vaccination and challenge) sequentially in a total of 6 cohorts. Each cohort will randomize 30 subjects to obtain approximately 25 subjects per cohort for the challenge phase. Subjects will be randomized in a ratio of 2:2:1 (VXA-A1.1: Quadrivalent Influenza Vaccine (QIV): Placebo.
The study will be conducted in two parts.
Part A: Subjects will be randomized in a double-blinded manner to receive a single administration of one of three treatment arms:
- Arm 1: VXA-A1.1 oral vaccine + placebo Intramuscular (IM)
- Arm 2: QIV (IM) injection + oral placebo
- Arm 3: Placebo IM injection + oral placebo
Subjects will return to the site for ~8 visits and be contacted remotely at defined time points to be followed for immunogenicity and safety during study Part A.
Part B: Subjects will be challenged with a wild-type influenza A H1 virus strain ~90 days following vaccination. Blood samples will be collected to evaluate immunogenicity. Subjects will remain in the isolation unit for 6 to 9 days post-challenge.
Following challenge, influenza symptoms and signs will be assessed during the sequestration period. Blood samples and nasopharyngeal swab samples will be collected. Vital signs will be measured every 4 hours during waking hours.
After release from the isolation unit subjects will return to the site 30 days post-challenge. Part B will continue for purposes of collecting long term safety follow-up (serious adverse events (SAEs), AEs of special interest (AESIs) and any new onset of chronic illness (NOCI) via phone contacts through 1 year post-vaccination (Day 365).
- Conditions
- Influenza
- Being tested
- VXA-A1.1, Fluzone®, Placebo Tablets, Saline Solution for Placebo IM Injection
- Keywords
- Challenge, oral vaccine
- 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-A1.1Biological
Also called Oral H1N1 Ad5 Tableted Vaccine
Enteric coated oral vaccine tablet
Fluzone®Biological
Also called Fluzone Quadravalent
Fluzone Quadravalent (Fluzone®) influenza vaccine (QIV) suspension for intramuscular (IM) injection
Placebo TabletsOther
Also called Enteric Coated Placebo Tablets
Placebo tablets similar in size, color and number to the active oral tablet vaccine drug product
Saline Solution for Placebo IM InjectionOther
Also called 0.9% Sodium Chloride Injection, USP
| Study group | Role | What they receive |
|---|---|---|
| Oral Vaccine (VXA-A1.1) | Experimental | Oral enteric coated vaccine tablets. Placebo (saline solution) IM injection will also be administered in this arm. Receives: Biological: VXA-A1.1; Other: Saline Solution for Placebo IM Injection |
| QIV IM Injection | Active comparator | A commercially available QIV will be administered at the approved dose level as the active comparator. Oral placebo tablets will also be administered in this arm. Receives: Biological: Fluzone®; Other: Placebo Tablets |
| Oral and IM Placebo | Placebo comparator | Two forms or placebos (saline IM injection and oral placebo tablets) will be administered in this arm. Receives: Other: Placebo Tablets; Other: Saline Solution for Placebo IM Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus
The clinical efficacy of VXA-A1.1 to protect against illness caused by the homologous A strain influenza virus with challenge 3 months following a single immunization in comparison to placebo and QIV. Participants were evaluated for clinical signs and symptoms of influenza as well as for viral shedding via PCR for confirmation of infection.
Measured: Clinical Illness and/or laboratory confirmed infection occurring following viral challenge at 3 months post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start31 Aug 2016
- Primary completion8 Aug 2017
- Study completion19 Jan 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.
- Publications (2)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Oral vaccination followed by viral challenge at 3 months post vaccination
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxart
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Sean Tucker, PhD, Study director, Vaxart, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918006
- Sponsor's protocol ID
- VXA-CHAL-201
- Status last verified
- Oct 2022
- First submitted
- 26 Sep 2016
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liebowitz D, Gottlieb K, Kolhatkar NS, Garg SJ, Asher JM, Nazareno J, Kim K, McIlwain DR, Tucker SN. Efficacy, immunogenicity, and safety of an oral influenza vaccine: a placebo-controlled and active-controlled phase 2 human challenge study. Lancet Infect Dis. 2020 Apr;20(4):435-444. doi: 10.1016/S1473-3099(19)30584-5. Epub 2020 Jan 21.
PubMed 31978354McIlwain DR, Chen H, Apkarian M, Affrime M, Bock B, Kim K, Mukherjee N, Nolan GP, McNeal MM. Performance of BioFire array or QuickVue influenza A + B test versus a validation qPCR assay for detection of influenza A during a volunteer A/California/2009/H1N1 challenge study. Virol J. 2021 Feb 25;18(1):45. doi: 10.1186/s12985-021-01516-0.
PubMed 33632249
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Controlled, Human Influenza A (H1N1) Challenge Study Following Administration of an Oral H1N1 HA Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02918006
- Acronym / sponsor ID
- VXA-CHAL-201
- Conditions
- Influenza
- Keywords
- Challenge, oral vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Posted 6 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.
Detailed description
This is a Phase 2 randomized, placebo- and active-controlled, two-part study in which healthy adult volunteers with low or undetectable pre-existing antibodies against A/California/7/2009(H1N1) pdm09-like virus will be challenged with an influenza A/H1N1 human challenge strain approximately 90 days after vaccination with a single dose of H1N1 HA Adenoviral-vector based seasonal influenza vaccine and dsRNA adjuvant (VXA-A1.1), an injectable QIV vaccine, and/or placebo.
An independent Safety Monitoring Committee (SMC) will oversee the safety of the study.
To accommodate the limited size of the isolation unit that will be utilized for the challenge and post-challenge sequestration period, subjects will move through the study (enrollment, vaccination and challenge) sequentially in a total of 6 cohorts. Each cohort will randomize 30 subjects to obtain approximately 25 subjects per cohort for the challenge phase. Subjects will be randomized in a ratio of 2:2:1 (VXA-A1.1: Quadrivalent Influenza Vaccine (QIV): Placebo.
The study will be conducted in two parts.
Part A: Subjects will be randomized in a double-blinded manner to receive a single administration of one of three treatment arms:
- Arm 1: VXA-A1.1 oral vaccine + placebo Intramuscular (IM)
- Arm 2: QIV (IM) injection + oral placebo
- Arm 3: Placebo IM injection + oral placebo
Subjects will return to the site for ~8 visits and be contacted remotely at defined time points to be followed for immunogenicity and safety during study Part A.
Part B: Subjects will be challenged with a wild-type influenza A H1 virus strain ~90 days following vaccination. Blood samples will be collected to evaluate immunogenicity. Subjects will remain in the isolation unit for 6 to 9 days post-challenge.
Following challenge, influenza symptoms and signs will be assessed during the sequestration period. Blood samples and nasopharyngeal swab samples will be collected. Vital signs will be measured every 4 hours during waking hours.
After release from the isolation unit subjects will return to the site 30 days post-challenge. Part B will continue for purposes of collecting long term safety follow-up (serious adverse events (SAEs), AEs of special interest (AESIs) and any new onset of chronic illness (NOCI) via phone contacts through 1 year post-vaccination (Day 365).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Oral vaccination followed by viral challenge at 3 months post vaccination
| Arm | Type | Receives |
|---|---|---|
| Oral Vaccine (VXA-A1.1) | Experimental | Biological: VXA-A1.1, Other: Saline Solution for Placebo IM InjectionOral enteric coated vaccine tablets. Placebo (saline solution) IM injection will also be administered in this arm. |
| QIV IM Injection | Active comparator | Biological: Fluzone®, Other: Placebo TabletsA commercially available QIV will be administered at the approved dose level as the active comparator. Oral placebo tablets will also be administered in this arm. |
| Oral and IM Placebo | Placebo comparator | Other: Placebo Tablets, Other: Saline Solution for Placebo IM InjectionTwo forms or placebos (saline IM injection and oral placebo tablets) will be administered in this arm. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female volunteers aged 18 - 49 years, inclusive
- Able to give written informed consent
- Low pre-existing antibodies to the study vaccine
- In general good health (no clinically significant health concerns)
- Safety laboratory normal range or not clinically significant (NCS), with few exceptions
Key exclusion criteria (19 listed)
- Receipt of any influenza vaccine within two years prior to study
- Use of any investigational vaccine/adjuvanted vaccine within 8 weeks of study
- Use of any investigational drug or device within 4 weeks of study
- Use of any licensed vaccine within 30 days of study
- Presence of significant uncontrolled medical or psychiatric illness within 3 months of study
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-A1.1Also: Oral H1N1 Ad5 Tableted VaccineEnteric coated oral vaccine tablet | Biological | Oral Vaccine (VXA-A1.1) |
| Fluzone®Also: Fluzone QuadravalentFluzone Quadravalent (Fluzone®) influenza vaccine (QIV) suspension for intramuscular (IM) injection | Biological | QIV IM Injection |
| Placebo TabletsAlso: Enteric Coated Placebo TabletsPlacebo tablets similar in size, color and number to the active oral tablet vaccine drug product | Other | Oral and IM Placebo, QIV IM Injection |
| Saline Solution for Placebo IM InjectionAlso: 0.9% Sodium Chloride Injection, USP | Other | Oral Vaccine (VXA-A1.1), Oral and IM Placebo |
Primary outcome
Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus
Time frame: Clinical Illness and/or laboratory confirmed infection occurring following viral challenge at 3 months post vaccination
The clinical efficacy of VXA-A1.1 to protect against illness caused by the homologous A strain influenza virus with challenge 3 months following a single immunization in comparison to placebo and QIV. Participants were evaluated for clinical signs and symptoms of influenza as well as for viral shedding via PCR for confirmation of infection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31978354Liebowitz D, Gottlieb K, Kolhatkar NS, Garg SJ, Asher JM, Nazareno J, Kim K, McIlwain DR, Tucker SN. Efficacy, immunogenicity, and safety of an oral influenza vaccine: a placebo-controlled and active-controlled phase 2 human challenge study. Lancet Infect Dis. 2020 Apr;20(4):435-444. doi: 10.1016/S1473-3099(19)30584-5. Epub 2020 Jan 21.
- Derived from this study: PubMed 33632249McIlwain DR, Chen H, Apkarian M, Affrime M, Bock B, Kim K, Mukherjee N, Nolan GP, McNeal MM. Performance of BioFire array or QuickVue influenza A + B test versus a validation qPCR assay for detection of influenza A during a volunteer A/California/2009/H1N1 challenge study. Virol J. 2021 Feb 25;18(1):45. doi: 10.1186/s12985-021-01516-0.
- 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.
Sean Tucker, 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 2 study testing VXA-A1.1 and Fluzone® 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 8 inclusion and 19 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 6 Oct 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 6 Oct 2022). 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?
Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus (time frame: Clinical Illness and/or laboratory confirmed infection occurring following viral challenge at 3 months post 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 NCT02918006, which also lists 2 linked publications.
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 6 Oct 2022.