A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: VXA-A1.1; Fluzone®; Placebo Tablets; Saline Solution for Placebo IM Injection
Intervention description: Enteric coated oral vaccine tablet; Fluzone Quadravalent (Fluzone®) influenza vaccine (QIV) suspension for intramuscular (IM) injection; Placebo tablets similar in size, color and number to the active oral tablet vaccine drug product
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Oral vaccination followed by viral challenge at 3 months post vaccination
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Challenge; oral vaccine

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.
    

Eligibility 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 not clinically significant (NCS), with few
             exceptions

          6. Body mass index (BMI) 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