NCT03121339

CompletedPhase 1

Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vacci...

Vaxart Source

Vaxart

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

VXA02-RLT-01

Study Type

interventional

Actual enrollment (reported)

8

Locations

1 country

Sites

1

Timeline

Study Start

March 31, 2017

Actual (reported)

Primary Completion

May 5, 2017

Actual (reported)

Study Completion

April 3, 2018

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 8 participants
Study completion date: April 3, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 31, 2017
Actual (reported)
First Submitted
April 14, 2017
Actual (reported)
First Posted
April 20, 2017
Actual (reported)
Primary Completion
May 5, 2017
Actual (reported)
Study Completion
April 3, 2018
Actual (reported)

Last Updated: May 30, 2018
Status Verified: May 2018
Last Update Submitted: May 29, 2018

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 ConditionTreatment B - Fed Condition

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

Tableted oral H1 vaccine (\~275 mg tablet)

Treatment A - Fasting Condition

Eligibility Criteria

Age18 Years - 49 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male volunteers aged 18 - 49 years, inclusive
Willing and able to give written informed consent/HIPAA authorization form

Sponsors & Collaborators

Vaxart
Industrylead

Study Sites (1)

Scintipharma, Inc.

Lexington, Kentucky, 40504, United States

Study Officials

David Liebowitz, MD, PhD
Vaxart, Inc.
STUDY DIRECTOR

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 20, 2017

Study Start

March 31, 2017

Actual (reported)

Treatment B - Fed Condition

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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,
+29 more criteria

Contact the study team to confirm eligibility.

Primary Completion

May 5, 2017

Actual (reported)

Study Completion

April 3, 2018

Actual (reported)

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03121339
Data provider: ClinicalTrials.gov
Source updated: 2018-05-30
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:20 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Treatment A - Fasting Condition

Treatment B - Fed Condition

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations