Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688297
• Other study ID #: VXA02-001 & VXA02-003
• 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
• 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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

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