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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01688297
Other study ID # VXA02-001 & VXA02-003
Secondary ID
Status Completed
Phase Phase 1
First received September 14, 2012
Last updated May 11, 2017
Start date September 2012
Est. completion date April 2015

Study information

Verified date May 2017
Source Vaxart
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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

High dose study was conducted under protocol number VXA02-003


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date April 2015
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
VXA-A1.1 Oral Vaccine
One or two doses of replication incompetent adenovirus oral tablet vaccine
VXA Placebo Tablet
Off-white tablets similarly formulated to the active drug product tablets.

Locations

Country Name City State
United States WCCT Cypress California

Sponsors (1)

Lead Sponsor Collaborator
Vaxart

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):1041-8. doi: 10.1016/S1473-3099(15 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events One year following last vaccination
Secondary Magnitude of humoral immune response to influenza as measured by functional assays 28 Days and 180 Days post-vaccination
Secondary Magnitude of cellular immune responses to influenza as measured by functional assays 28 Days and 180 Days post-vaccination
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