Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01688297

Enrollment

Registered

2012-09-19

Start date

2012-09-30

Completion date

2015-04-30

Last updated

2017-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, H1N1, flu, seasonal

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

Interventions

BIOLOGICALVXA-A1.1 Oral Vaccine

One or two doses of replication incompetent adenovirus oral tablet vaccine

BIOLOGICALVXA Placebo Tablet

Off-white tablets similarly formulated to the active drug product tablets.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events	One year following last vaccination

Secondary

Measure	Time frame
Magnitude of humoral immune response to influenza as measured by functional assays	28 Days and 180 Days post-vaccination
Magnitude of cellular immune responses to influenza as measured by functional assays	28 Days and 180 Days post-vaccination

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026