NCT01761123 (ICC H1) is a Phase 1 clinical trial of VXA-A1.1 in Seasonal Influenza, sponsored by Vaxart.

Who is sponsoring NCT01761123?

NCT01761123 is sponsored by Vaxart.

What drugs are being tested in NCT01761123?

Interventions in NCT01761123: VXA-A1.1.

What condition does NCT01761123 study?

NCT01761123 studies Seasonal Influenza.

Is NCT01761123 still recruiting?

NCT01761123 is currently completed. Last updated 8 December 2014.

Last reviewed 2014-12-08 · How we verify

NCT01761123: ICC H1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open Label Phase I Substudy to Evaluate the Safety and Ability to Enhance Immunogenicity of VXA-A1.1 by Delivery Directly to the Ileum Using the InteliSite Companion Capsule in Healthy Adult Males

Completed Phase 1 Last updated 8 December 2014

What this trial tests

Phase 1 trial testing VXA-A1.1 in Seasonal Influenza in 37 participants. Completed in 1 October 2014.

Timeline

1 January 2013

Primary endpoint
1 October 2014

1 October 2014

Quick facts

Lead sponsor	Vaxart
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	37
Start date	1 January 2013
Primary completion	1 October 2014
Estimated completion	1 October 2014
Sites	1 location across United States

Drugs / interventions tested

VXA-A1.1 — full drug profile →

Conditions studied

Seasonal Influenza — all drugs for Seasonal Influenza →

Sponsor

Vaxart — full company profile →

Who can join

Adults 18 to 49, male only, with Seasonal Influenza. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety
Time frame: 1 year
Frequency and magnitude of adverse events

Sponsor's own description

the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of VXA-A1.1 oral vaccine.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Adenoviral Vector-Based Vaccine Platforms for Developing the Next Generation of Influenza Vaccines.
Sayedahmed EE, Elkashif A, Alhashimi M, Sambhara S, et al · · 2020 · cited 46× · PMID 33019589 · DOI 10.3390/vaccines8040574
Systemic and mucosal immune responses following oral adenoviral delivery of influenza vaccine to the human intestine by radio controlled capsule.
Kim L, Martinez CJ, Hodgson KA, Trager GR, et al · · 2016 · cited 34× · PMID 27881837 · DOI 10.1038/srep37295
Clinical Advances in Viral-Vectored Influenza Vaccines.
Sebastian S, Lambe T. · · 2018 · cited 33× · PMID 29794983 · DOI 10.3390/vaccines6020029
Adenoviral vector-based platforms for developing effective vaccines to combat respiratory viral infections.
Elkashif A, Alhashimi M, Sayedahmed EE, Sambhara S, et al · · 2021 · cited 27× · PMID 34667600 · DOI 10.1002/cti2.1345
A Decade in Review: A Systematic Review of Universal Influenza Vaccines in Clinical Trials during the 2010 Decade.
Corder BN, Bullard BL, Poland GA, Weaver EA. · · 2020 · cited 26× · PMID 33092070 · DOI 10.3390/v12101186
Update on Influenza Vaccines: Needs and Progress.
Kennedy RB, Ovsyannikova IG, Poland GA. · · 2021 · cited 5× · PMID 34416408 · DOI 10.1016/j.jaip.2021.08.003

Verify or expand the search:

Other trials of VXA-A1.1

Trials testing the same drug.

NCT02918006 — A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine · Phase 2 · completed

Other recruiting trials for Seasonal Influenza

Currently open trials in the same condition.

NCT06863142 — Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP · Phase 1 · recruiting

Other Vaxart trials

Trials by the same sponsor.

NCT06944717 — A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years · Phase 1 · active not recruiting
NCT07254728 — A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing I · Phase 1 · completed
NCT05626803 — A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers · Phase 2 · completed
NCT05213728 — A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-v · Phase 1 · completed
NCT05212168 — Norovirus Challenge Study · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01761123 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vaxart
Last refreshed: 8 December 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01761123.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing