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Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01688297
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Vaxart

Brief Summary:
The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).

Condition or disease Intervention/treatment Phase
Influenza Biological: VXA-A1.1 Oral Vaccine Biological: VXA Placebo Tablet Phase 1

Detailed Description:

Low and mid dose study was conducted under protocol number VXA02-001

High dose study was conducted under protocol number VXA02-003

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Phase 1 Double-Blinded Placebo Controlled Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Seasonal Influenza A Vaccine and dsRNA Adjuvant Administered Orally to Healthy Volunteers
Study Start Date : September 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Low Dose VXA-A1.1 Oral Vaccine
Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.
Biological: VXA-A1.1 Oral Vaccine
One or two doses of replication incompetent adenovirus oral tablet vaccine
Other Name: Ad-HA-dsRNA (VXA-A1.1)

Placebo Comparator: VXA Placebo Tablet
Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design.
Biological: VXA Placebo Tablet
Off-white tablets similarly formulated to the active drug product tablets.
Other Name: Placebo Control

Experimental: Medium Dose VXA-A1.1 Oral Vaccine
Two doses of replication incompetent adenovirus vaccine given in an oral tablet
Biological: VXA-A1.1 Oral Vaccine
One or two doses of replication incompetent adenovirus oral tablet vaccine
Other Name: Ad-HA-dsRNA (VXA-A1.1)

Experimental: High Dose VXA-A1.1 Oral Vaccine
One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003.
Biological: VXA-A1.1 Oral Vaccine
One or two doses of replication incompetent adenovirus oral tablet vaccine
Other Name: Ad-HA-dsRNA (VXA-A1.1)




Primary Outcome Measures :
  1. Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events [ Time Frame: One year following last vaccination ]

Secondary Outcome Measures :
  1. Magnitude of humoral immune response to influenza as measured by functional assays [ Time Frame: 28 Days and 180 Days post-vaccination ]
  2. Magnitude of cellular immune responses to influenza as measured by functional assays [ Time Frame: 28 Days and 180 Days post-vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.

Exclusion Criteria:

  • Positive for H1 influenza by HAI.
  • Has had an influenza vaccine in the past 2 years.
  • Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
  • History of any confirmed or suspected immunodeficient or immunosuppressive condition
  • Positive serology for HIV, HCV, or HBV
  • 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 of the vaccine targeting the mucosa of the small intestine
  • Use of proton pump inhibitors(Nexium, Prilosec).
  • Stool sample with occult blood at baseline exam

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688297


Locations
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United States, California
WCCT
Cypress, California, United States, 90630
Sponsors and Collaborators
Vaxart
Investigators
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Study Director: David Liebowitz, MD, PhD Vaxart, Inc.
Principal Investigator: Apinya Vutikullird, DO WCCT
Publications of Results:
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Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT01688297    
Other Study ID Numbers: VXA02-001 & VXA02-003
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vaxart:
Influenza
H1N1
flu
seasonal
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases