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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02918006
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
Vaxart

Tracking Information
First Submitted Date  ICMJE September 26, 2016
First Posted Date  ICMJE September 28, 2016
Last Update Posted Date July 26, 2018
Actual Study Start Date  ICMJE August 31, 2016
Actual Primary Completion Date May 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
Occurrence of influenza [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine
Official Title  ICMJE Phase 2 Randomized, Controlled, Human Influenza A (H1N1) Challenge Study Following Administration of an Oral H1N1 HA Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant to Healthy Adult Volunteers
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 HA Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.
Detailed Description

This is a Phase 2 randomized, placebo- and active-controlled, two-part study in which healthy adult volunteers with low or undetectable pre-existing antibodies against A/California/7/2009(H1N1) pdm09-like virus will be challenged with an influenza A/H1N1 human challenge strain approximately 90 days after vaccination with a single dose of H1N1 HA Adenoviral-vector based seasonal influenza vaccine and dsRNA adjuvant (VXA-A1.1), an injectable QIV vaccine, and/or placebo.

An independent SMC will oversee the safety of the study.

To accommodate the limited size of the isolation unit that will be utilized for the challenge and post-challenge sequestration period, subjects will move through the study (enrollment, vaccination and challenge) sequentially in a total of 6 cohorts. Each cohort will randomize 30 subjects to obtain approximately 25 subjects per cohort for the challenge phase. Subjects will be randomized in a ratio of 2:2:1 (VXA-A1.1: QIV: Placebo).

The study will be conducted in two parts.

Part A: Subjects will be randomized in a double-blinded manner to receive a single administration of one of three treatment arms:

  • Arm 1: VXA-A1.1 oral vaccine + placebo IM
  • Arm 2: QIV IM injection + oral placebo
  • Arm 3: Placebo IM injection + oral placebo

Subjects will return to the site for ~8 visits and be contacted remotely at defined time points to be followed for immunogenicity and safety during study Part A.

Part B: Subjects will be challenged with a wild-type influenza A H1 virus strain ~90 days following vaccination. Blood samples will be collected to evaluate immunogenicity. Subjects will remain in the isolation unit for 6 to 9 days post-challenge.

Following challenge, influenza symptoms and signs will be assessed during the sequestration period. Blood samples and nasopharyngeal swab samples will be collected. Vital signs will be measured every 4 hours during waking hours.

After release from the isolation unit subjects will return to the site 30 days post-challenge. Part B will continue for purposes of collecting long term safety follow-up (SAEs and AESIs/NOCIs) via phone contacts through 1 year post-vaccination (Day 365).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: VXA-A1.1
    Enteric coated oral vaccine tablet
    Other Name: Oral H1N1 Ad5 Tableted Vaccine
  • Biological: Fluzone®
    Fluzone Quadravalent (Fluzone®) influenza vaccine (QIV) suspension for intramuscular (IM) injection
    Other Name: Fluzone Quadravalent
  • Other: Placebo Tablets
    Placebo tablets similar in size, color and number to the active oral tablet vaccine drug product
    Other Name: Enteric Coated Placebo Tablets
  • Other: Saline Solution for Placebo IM Injection
    Other Name: 0.9% Sodium Chloride Injection, USP
Study Arms  ICMJE
  • Experimental: Oral Vaccine (VXA-A1.1)
    Oral enteric coated vaccine tablets. Placebo (saline solution) IM injection will also be administered in this arm.
    Interventions:
    • Biological: VXA-A1.1
    • Other: Saline Solution for Placebo IM Injection
  • Active Comparator: QIV IM Injection
    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.
    Interventions:
    • Biological: Fluzone®
    • Other: Placebo Tablets
  • Placebo Comparator: Oral and IM Placebo
    Two forms or placebos (saline IM injection and oral placebo tablets) will be administered in this arm.
    Interventions:
    • Other: Placebo Tablets
    • Other: Saline Solution for Placebo IM Injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2018)
179
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2016)
180
Actual Study Completion Date  ICMJE January 19, 2018
Actual Primary Completion Date May 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female volunteers aged 18 - 49 years, inclusive
  2. Able to give written informed consent
  3. Low pre-existing antibodies to the study vaccine
  4. In general good health (no clinically significant health concerns)
  5. Safety laboratory normal range or NCS (with few exceptions)
  6. Body mass index between 17 and 35
  7. Comprehension of the study requirements with ability and willingness to complete all assessments and comply with scheduled visits and contacts
  8. Female participants must have a negative pregnancy test at screening

Exclusion Criteria:

  1. Receipt of any influenza vaccine within two years prior to study
  2. Use of any investigational vaccine/adjuvanted vaccine within 8 weeks of study
  3. Use of any investigational drug or device within 4 weeks of study
  4. Use of any licensed vaccine within 30 days of study
  5. Presence of significant uncontrolled medical or psychiatric illness within 3 months of study
  6. Clinically significant and/or protocol defined ECG abnormality
  7. Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
  8. Cancer, or treatment for cancer, within 3 years of study
  9. History of drug, alcohol or chemical abuse within 1 year
  10. Receipt of blood or blood products within 6 months of study
  11. Donation of blood within 4 weeks of study
  12. Presence of a fever ≥ 38ºC measured orally at baseline
  13. Stool sample with occult blood at screening
  14. Positive urine drug screen for drugs of abuse at screening
  15. Positive breath or urine alcohol test at screening or baseline
  16. Consistent/habitual smoking within 2 months prior to vaccination
  17. History of serious reactions to any vaccination such as anaphylaxis, respiratory problems, Guillain-Barre syndrome, hives or abdominal pain
  18. Asthma, bronchiectasis or chronic obstructive pulmonary disease
  19. Any known allergy or intolerance to oseltamivir
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02918006
Other Study ID Numbers  ICMJE VXA-CHAL-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Vaxart
Study Sponsor  ICMJE Vaxart
Collaborators  ICMJE Biomedical Advanced Research and Development Authority
Investigators  ICMJE
Study Director: Dave Liebowitz, MD, PhD Vaxart, Inc.
PRS Account Vaxart
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP