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

NCT03121339 | Completed Phase 1 FDA Drug

• 1 other identifier: VXA02-RLT-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. The secondary objective is to evaluate delivery with fasting versus fed status.

Conditions

Seasonal Influenza Preventative Vaccine Pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• PD: Location of disintegration

  Site of initial and complete disintegration of the study DP

  7 days

• PD: Time to disintegration

  Time of initial and complete disintegration of the study DP

  7 days

Study Arms (2)

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.

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.

Biological: VXA-A1.1 H1 Tablet Vaccine (small); Biological: VXA-A1.1 H1 Tablet Vaccine (large)

Interventions

VXA-A1.1 H1 Tablet Vaccine (small) BIOLOGICAL

Tableted oral H1 vaccine (\~140 mg tablet)

Treatment A - Fasting Condition; Treatment B - Fed Condition

VXA-A1.1 H1 Tablet Vaccine (large) BIOLOGICAL

Tableted oral H1 vaccine (\~275 mg tablet)

Treatment A - Fasting Condition; Treatment B - Fed Condition

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.
• 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.

You may not qualify if:

• 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)
• 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,

Sponsors & Collaborators

• Vaxart: lead

Study Sites (1)

Scintipharma, Inc.

Lexington, Kentucky, 40504, United States

Location

Study Officials

• David Liebowitz, MD, PhD

  Vaxart, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label with two tablet sizes labeled with different radioisotopes

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 20, 2017
• Study Start: March 31, 2017
• Primary Completion: May 5, 2017
• Study Completion: April 3, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)