Seasonal Influenza Preventative Vaccine PharmacodynamicsPhase 1NCT03121339

Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy Adults

A Phase 1 study testing VXA-A1.1 H1 Tablet Vaccine (small) and VXA-A1.1 H1 Tablet Vaccine (large) in people with Seasonal Influenza Preventative Vaccine Pharmacodynamics, run by Vaxart at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, has an impact on delivery location. Read more about this study

Who is it for?: Ages 18 to 49 years, men onlyHealthy volunteers can take part
Conditions the study is for: Seasonal Influenza Preventative Vaccine Pharmacodynamics
What is being tested?: VXA-A1.1 H1 Tablet Vaccine (small) and VXA-A1.1 H1 Tablet Vaccine (large)
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 31 Mar 2017to 3 Apr 2018
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male volunteers aged 18 - 49 years, inclusive
Willing and able to give written informed consent/HIPAA authorization form
In good health (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, vital signs and laboratory tests at screening
Liver function tests (alanine aminotransferase (ALT), aspartate amino transferase (AST), alkaline phosphatase (ALP), direct bilirubin (DB) and total bilirubin (TB) are within the normal range. [N.B., an elevated TB in the absence of an elevated direct bilirubin (benign unconjugated hyperbilirubinemia, known as Gilbert's Syndrome) will not be exclusionary]
Body weight ≥ 50 kg and a Body mass index between 17 and 35 at screening
Willingness to abstain from caffeine or xanthine containing foods or beverages, alcohol, tobacco or nicotine-containing products and strenuous exercise from 72 hours prior to screening and each dosing until discharge post each Dosing Day.

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Dietary habits that fall within the range of normal, as determined by the Investigator. Examples of abnormal diets are liquid diets, protein only diets, high fat diets, or low carbohydrate diets.
Verbal confirmation from subject that his bowel movements are regular.
Comprehension of the study requirements (in English) with ability and willingness to complete all assessments and comply with scheduled visits and contacts.

Who cannot join

Administration of any vaccine within 4 weeks preceding DP administration or during the study through the active period (Day 36), or any licensed or investigational adjuvanted vaccine within 12 months preceding DP administration, or planned use of any licensed or investigational adjuvanted vaccine during the study through the 12-month safety follow- up period
Use of any investigational drug or device the greater of: within 4 weeks preceding DP administration, or planned use of the above stated during the study through the study active period (Day 36) OR within 5 half-lives of an investigational drug product
Use of concomitant medications that may interfere with normal gastrointestinal tract function, including but not limited to those listed below:
Proton pump inhibitors
H2 blockers
GI motility stimulants (e.g. metoclopramide)

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Anti-nausea/anti-emetics
Opiate class pain relievers
Anti-diarrheals
Laxatives
Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening
Any one of the following ECG findings within 30 days prior to administration:
QTc F (interval duration > 450 msec (male),
QRS interval greater than 120 msec,
PR interval greater than 220 msec,
Clinically significant ST-T wave changes or pathologic Q waves
Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
Cancer, or treatment for cancer, within past 3 years (excluding basal cell carcinoma, squamous cell carcinoma, and cervical cancer in situ)
Radiation exposure from clinical trials, including that from the present study, and from diagnostic X-rays, but excluding background radiation, exceeding a target organ (colon) dose of 50 mSv (5 rems) from a single dose within the last 30 days or a cumulative dose of 150 mSv (15 rems) in the last 12 months. No subject whose occupation requires monitoring for radiation exposure may be enrolled in the study.
Presence of household members who are neonates, pregnant women, or hematopoietic stem cell transplant or solid organ transplant recipients or who are immunocompromised including those who are HIV positive.
History of drug, alcohol or chemical abuse within 1 year prior to administration
Acute disease within 72 hours prior to administration defined as the presence of a moderate or severe illness with or without fever (as determined by the Investigator through medical history and physical examination) or any acute respiratory or gastrointestinal illness even with mild symptoms occurring within 7 days of administration
Presence of a fever ≥ 38ºC measured orally at baseline
Positive urine drug screen for drugs of abuse at screening
Positive breath or urine alcohol test at screening
Consistent/habitual smoking (> 10 cigarettes/day) within 6 months prior to administration
History or presence of acute/chronic diarrhea or constipation
History of serious reactions to any vaccination such as anaphylaxis, respiratory problems, Guillain-Barre syndrome, hives or abdominal pain
History of a hypersensitivity or allergic reaction to any component of the investigational DP, including but not limited to fish gelatin
History of irritable bowel disease or inflammatory digestive or gastrointestinal condition that could affect the distribution / safety evaluation of an orally administered DP targeting the mucosa of the small intestine. Such conditions may include but are not limited to:
Esophageal Motility Disorder
Malignancy
Malabsorption
Pancreaticobiliary disorders
Irritable bowel syndrome
Celiac Disease
Inflammatory Bowel Disease
Surgical Resection with the exception of appendectomy or a minor resection that is deemed acceptable by investigator and sponsor
GERD
Hiatal Hernia
Peptic Ulcer (History of cholecystectomy is not exclusionary)
Any condition that resulted in the absence or removal of the spleen
History of any form of angioedema
Male subject who is unwilling to use an acceptable method of contraception, as listed below, for the duration of the study and continuing for 90 days after the subject's last study DP dose. Acceptable methods of contraception include the following: (1) complete abstinence from intercourse beginning with the first dose of study DP and continuing for 90 days after the final study DP dose, (2) male subject sterilization (vasectomy), (3) sterilization of or non-childbearing potential female partner (bilateral tubal ligation/salpingectomy, hysterectomy, post-menopausal), (4) use of hormonal contraception by female partner (implantable, patch, oral, injectable), (5) use of an intrauterine device (IUD) or intrauterine system by female partner, (6) barrier methods (condom by male or an occlusive cap [diaphragm or cervical/vault caps] by female partner) with concomitant spermicidal foam/gel/film/cream/suppository use, (7) any other birth control method with published data showing a failure rate that is < 1% per year. Male subjects should not donate sperm for the duration of the study and for 90 days after the last DP dose. Male subjects who are not sexually active but become active, must comply with the contraceptive requirements above.
Any condition that, in the opinion of the Investigator, might interfere with ability to assess the primary study objectives

Trial locations and contacts

1 site in 1 country.

United States1 site

Scintipharma, Inc.
Lexington, Kentucky, 40504

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Randomized, 2×2 Crossover Study of Pharmacodynamics Comparing the Impact of Tablet Size and Fasting Status With an Oral Human Influenza A/California/04/2009 (H1N1) HA Adenoviral-Vector Based Vaccine and dsRNA Adjuvant

Read the detailed description

This is a pharmacodynamics study in healthy adult males. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, impacts the location and time of initial and complete disintegration of the drug product. The secondary objective is to evaluate delivery with fasting versus fed status.

Conditions: Seasonal Influenza Preventative Vaccine Pharmacodynamics
Being tested: VXA-A1.1 H1 Tablet Vaccine (small), VXA-A1.1 H1 Tablet Vaccine (large)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VXA-A1.1 H1 Tablet Vaccine (small)Biological
Tableted oral H1 vaccine (~140 mg tablet)
VXA-A1.1 H1 Tablet Vaccine (large)Biological
Tableted oral H1 vaccine (~275 mg tablet)

Study groups in NCT03121339
Study group	Role	What they receive
Treatment A - Fasting Condition	Active comparator	Radio-labeled VXA-A1.1 H1 Tablet Vaccine (small) and VXA-A1.1 H1 Tablet Vaccine (large) will be administered to fasted subjects. Receives: Biological: VXA-A1.1 H1 Tablet Vaccine (small); Biological: VXA-A1.1 H1 Tablet Vaccine (large)
Treatment B - Fed Condition	Active comparator	Radio-labeled VXA-A1.1 H1 Tablet Vaccine (small) and VXA-A1.1 H1 Tablet Vaccine (large) will be administered to subjects with a small snack. Receives: Biological: VXA-A1.1 H1 Tablet Vaccine (small); Biological: VXA-A1.1 H1 Tablet Vaccine (large)

What is being measured

The primary outcome is the main question the study is designed to answer.

PD: Location of disintegration
Site of initial and complete disintegration of the study DP
Measured: 7 days
PD: Time to disintegration
Time of initial and complete disintegration of the study DP
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 20173 Apr 2018

First posted20 Apr 2017
Study start31 Mar 2017
Primary completion5 May 2017
Study completion3 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Seasonal Influenza Preventative Vaccine PharmacodynamicsStudies 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: Randomised
Intervention model: Parallel groups
Model description: open-label with two tablet sizes labeled with different radioisotopes
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03121339
Sponsor's protocol ID: VXA02-RLT-01
Status last verified: May 2018
First submitted: 14 Apr 2017
Last updated: 30 May 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Randomized, 2×2 Crossover Study of Pharmacodynamics Comparing the Impact of Tablet Size and Fasting Status With an Oral Human Influenza A/California/04/2009 (H1N1) HA Adenoviral-Vector Based Vaccine and dsRNA Adjuvant
ClinicalTrials.gov ID: NCT03121339
Acronym / sponsor ID: VXA02-RLT-01
Conditions: Seasonal Influenza Preventative Vaccine Pharmacodynamics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: VaxartIndustry (pharma, biotech, devices)
Study start: 31 Mar 2017 (actual)
Primary completion: 5 May 2017 (actual)
Study completion: 3 Apr 2018 (actual)
First posted: 20 Apr 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: open-label with two tablet sizes labeled with different radioisotopes

Arm	Type	Receives
Treatment A - Fasting Condition	Active comparator	Biological: VXA-A1.1 H1 Tablet Vaccine (small), Biological: VXA-A1.1 H1 Tablet Vaccine (large)Radio-labeled VXA-A1.1 H1 Tablet Vaccine (small) and VXA-A1.1 H1 Tablet Vaccine (large) will be administered to fasted subjects.
Treatment B - Fed Condition	Active comparator	Biological: VXA-A1.1 H1 Tablet Vaccine (small), Biological: VXA-A1.1 H1 Tablet Vaccine (large)Radio-labeled VXA-A1.1 H1 Tablet Vaccine (small) and VXA-A1.1 H1 Tablet Vaccine (large) will be administered to subjects with a small snack.

Who may qualify

Ages: 18 to 49 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Male volunteers aged 18 - 49 years, inclusive
Willing and able to give written informed consent/HIPAA authorization form
In good health (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, vital signs and laboratory tests at screening
Liver function tests (alanine aminotransferase (ALT), aspartate amino transferase (AST), alkaline phosphatase (ALP), direct bilirubin (DB) and total bilirubin (TB) are within the normal range. [N.B., an elevated TB in the absence of an elevated direct bilirubin (benign unconjugated hyperbilirubinemia, known as Gilbert's Syndrome) will not be exclusionary]
Body weight ≥ 50 kg and a Body mass index between 17 and 35 at screening

Key exclusion criteria (45 listed)

Administration of any vaccine within 4 weeks preceding DP administration or during the study through the active period (Day 36), or any licensed or investigational adjuvanted vaccine within 12 months preceding DP administration, or planned use of any licensed or investigational adjuvanted vaccine during the study through the 12-month safety follow- up period
Use of any investigational drug or device the greater of: within 4 weeks preceding DP administration, or planned use of the above stated during the study through the study active period (Day 36) OR within 5 half-lives of an investigational drug product
Use of concomitant medications that may interfere with normal gastrointestinal tract function, including but not limited to those listed below:
Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening
Any one of the following ECG findings within 30 days prior to administration:

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 H1 Tablet Vaccine (small)Tableted oral H1 vaccine (~140 mg tablet)	Biological	Treatment A - Fasting Condition, Treatment B - Fed Condition
VXA-A1.1 H1 Tablet Vaccine (large)Tableted oral H1 vaccine (~275 mg tablet)	Biological	Treatment A - Fasting Condition, Treatment B - Fed Condition

Primary outcome

PD: Location of disintegration
Time frame: 7 days
Site of initial and complete disintegration of the study DP
PD: Time to disintegration
Time frame: 7 days
Time of initial and complete disintegration of the study DP

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 30 May 2018.
Individual participant dataSharing planned: No

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?

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 9 inclusion and 45 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 30 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 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?

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?

PD: Location of disintegration (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT03121339.

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 30 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.