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

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ClinicalTrials.gov Identifier: NCT02918006
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : September 28, 2016
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
Vaxart

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: VXA-A1.1 Biological: Fluzone® Other: Placebo Tablets Other: Saline Solution for Placebo IM Injection Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Oral Vaccine (VXA-A1.1)
Oral enteric coated vaccine tablets. Placebo (saline solution) IM injection will also be administered in this arm.
Biological: VXA-A1.1
Enteric coated oral vaccine tablet
Other Name: Oral H1N1 Ad5 Tableted Vaccine

Other: Saline Solution for Placebo IM Injection
Other Name: 0.9% Sodium Chloride Injection, USP

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.
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

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




Primary Outcome Measures :
  1. Occurrence of influenza [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918006


Contacts
Contact: Shaily J Garg, BS, PMP 650-550-3500 sgarg@vaxart.com
Contact: Dave Liebowitz, MD, PhD 650-550-3500 dliebowitz@vaxart.com

Locations
United States, California
WCCT Global Recruiting
Costa Mesa, California, United States, 92626
Contact: Maria Apkarian    562-505-7576    maria.apkarian@wcct.com   
Sponsors and Collaborators
Vaxart
Biomedical Advanced Research and Development Authority
Investigators
Study Director: Dave Liebowitz, MD, PhD Vaxart, Inc.

Responsible Party: Vaxart
ClinicalTrials.gov Identifier: NCT02918006     History of Changes
Other Study ID Numbers: VXA-CHAL-201
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs