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

NCT02918006 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VXA-CHAL-201
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.

Conditions

Influenza

Keywords

Challenge; oral vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus

  The clinical efficacy of VXA-A1.1 to protect against illness caused by the homologous A strain influenza virus with challenge 3 months following a single immunization in comparison to placebo and QIV. Participants were evaluated for clinical signs and symptoms of influenza as well as for viral shedding via PCR for confirmation of infection.

  Clinical Illness and/or laboratory confirmed infection occurring following viral challenge at 3 months post vaccination

Study Arms (3)

Oral Vaccine (VXA-A1.1)

EXPERIMENTAL

Oral enteric coated vaccine tablets. Placebo (saline solution) IM injection will also be administered in this arm.

Biological: VXA-A1.1; Other: Saline Solution for Placebo IM Injection

QIV IM Injection

ACTIVE COMPARATOR

A commercially available QIV will be administered at the approved dose level as the active comparator. Oral placebo tablets will also be administered in this arm.

Biological: Fluzone®; Other: Placebo Tablets

Oral and IM Placebo

PLACEBO COMPARATOR

Two forms or placebos (saline IM injection and oral placebo tablets) will be administered in this arm.

Other: Placebo Tablets; Other: Saline Solution for Placebo IM Injection

Interventions

VXA-A1.1 BIOLOGICAL

Enteric coated oral vaccine tablet

Also known as: Oral H1N1 Ad5 Tableted Vaccine

Oral Vaccine (VXA-A1.1)

Fluzone® BIOLOGICAL

Fluzone Quadravalent (Fluzone®) influenza vaccine (QIV) suspension for intramuscular (IM) injection

Also known as: Fluzone Quadravalent

QIV IM Injection

Placebo Tablets OTHER

Placebo tablets similar in size, color and number to the active oral tablet vaccine drug product

Also known as: Enteric Coated Placebo Tablets

Oral and IM Placebo; QIV IM Injection

Saline Solution for Placebo IM Injection OTHER

Also known as: 0.9% Sodium Chloride Injection, USP

Oral Vaccine (VXA-A1.1); Oral and IM Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female volunteers aged 18 - 49 years, inclusive
• Able to give written informed consent
• Low pre-existing antibodies to the study vaccine
• In general good health (no clinically significant health concerns)
• Safety laboratory normal range or not clinically significant (NCS), with few exceptions
• Body mass index (BMI) between 17 and 35
• Comprehension of the study requirements with ability and willingness to complete all assessments and comply with scheduled visits and contacts
• Female participants must have a negative pregnancy test at screening

You may not qualify if:

• Receipt of any influenza vaccine within two years prior to study
• Use of any investigational vaccine/adjuvanted vaccine within 8 weeks of study
• Use of any investigational drug or device within 4 weeks of study
• Use of any licensed vaccine within 30 days of study
• Presence of significant uncontrolled medical or psychiatric illness within 3 months of study
• Clinically significant and/or protocol defined ECG abnormality
• Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
• Cancer, or treatment for cancer, within 3 years of study
• History of drug, alcohol or chemical abuse within 1 year
• Receipt of blood or blood products within 6 months of study
• Donation of blood within 4 weeks of study
• Presence of a fever ≥ 38ºC measured orally at baseline
• Stool sample with occult blood at screening
• Positive urine drug screen for drugs of abuse at screening
• Positive breath or urine alcohol test at screening or baseline

Sponsors & Collaborators

• Vaxart: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

WCCT Global

Costa Mesa, California, 92626, United States

Location

Related Publications (2)

• Liebowitz D, Gottlieb K, Kolhatkar NS, Garg SJ, Asher JM, Nazareno J, Kim K, McIlwain DR, Tucker SN. Efficacy, immunogenicity, and safety of an oral influenza vaccine: a placebo-controlled and active-controlled phase 2 human challenge study. Lancet Infect Dis. 2020 Apr;20(4):435-444. doi: 10.1016/S1473-3099(19)30584-5. Epub 2020 Jan 21.

  PMID: 31978354 RESULT

• McIlwain DR, Chen H, Apkarian M, Affrime M, Bock B, Kim K, Mukherjee N, Nolan GP, McNeal MM. Performance of BioFire array or QuickVue influenza A + B test versus a validation qPCR assay for detection of influenza A during a volunteer A/California/2009/H1N1 challenge study. Virol J. 2021 Feb 25;18(1):45. doi: 10.1186/s12985-021-01516-0.

  PMID: 33632249 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Sean Tucker, PhD, Chief Scientific Officer
• Organization: Vaxart, Inc.

stucker@vaxart.com

650-550-3502

Study Officials

• Sean Tucker, PhD

  Vaxart, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Oral vaccination followed by viral challenge at 3 months post vaccination

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 28, 2016
• Study Start: August 31, 2016
• Primary Completion: August 8, 2017
• Study Completion: January 19, 2018
• Last Updated: October 6, 2022
• Results First Posted: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)