Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE September 14, 2012
First Posted Date  ICMJE September 19, 2012
Last Update Posted Date May 12, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events [ Time Frame: One year following last vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
Frequency or severity of vaccine related events as measured through reported AEs. [ Time Frame: up to 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
  • Magnitude of humoral immune response to influenza as measured by functional assays [ Time Frame: 28 Days and 180 Days post-vaccination ]
  • Magnitude of cellular immune responses to influenza as measured by functional assays [ Time Frame: 28 Days and 180 Days post-vaccination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
  • Magnitude of humoral immune response to influenza as measured by functional assays [ Time Frame: up to 1 year ]
  • Magnitude of cellular immune responses to influenza as measured by functional assays [ Time Frame: up to 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of an Oral Vaccine to Prevent Seasonal Influenza
Official Title  ICMJE 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
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).
Detailed Description

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

High dose study was conducted under protocol number VXA02-003

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • 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)
  • Biological: VXA Placebo Tablet
    Off-white tablets similarly formulated to the active drug product tablets.
    Other Name: Placebo Control
Study Arms  ICMJE
  • Experimental: Low Dose VXA-A1.1 Oral Vaccine
    Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation.
    Intervention: Biological: VXA-A1.1 Oral Vaccine
  • 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.
    Intervention: Biological: VXA Placebo Tablet
  • Experimental: Medium Dose VXA-A1.1 Oral Vaccine
    Two doses of replication incompetent adenovirus vaccine given in an oral tablet
    Intervention: Biological: VXA-A1.1 Oral Vaccine
  • 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.
    Intervention: Biological: VXA-A1.1 Oral Vaccine
Publications * Liebowitz D, Lindbloom JD, Brandl JR, Garg SJ, Tucker SN. High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial. Lancet Infect Dis. 2015 Sep;15(9):1041-1048. doi: 10.1016/S1473-3099(15)00266-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2017)
61
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2012)
36
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01688297
Other Study ID Numbers  ICMJE VXA02-001 & VXA02-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vaxart
Study Sponsor  ICMJE Vaxart
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Liebowitz, MD, PhD Vaxart, Inc.
Principal Investigator: Apinya Vutikullird, DO WCCT
PRS Account Vaxart
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP