Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults >= 65 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: VAX125
Intervention description: STF2.HA1(SI) (VAX125), which is a recombinant fusion protein that consists of Salmonella typhimurium flagellin type 2 (STF2), a Toll-like receptor 5 (TLR5) ligand, fused at its C-terminus to the globular head domain of the hemagglutinin (HA) antigen of influenza A HA1 Solomon Islands (SI).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza; vaccine

Summary:

      A multi-center, open-label, escalating dose-ranging study to assess the safety,
      reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg,
      2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125
      is safe and immunogenic at one or more of the doses tested.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men or women aged 65 or older; female subjects must be post menopausal.

          -  Live in the community, independently or in an assisted living environment

          -  Based on the results of the Short Portable Mental Status Questionnaire (SPMSQ), be
             rated as normal or have no greater than mild severity dementia.

          -  As defined by the Canadian Study of Health and Aging Clinical Frailty Scale
             (CSHA-CFS), fitness ranging from very fit to mildly frail; Classes 1 to 5 of 7.

          -  Healthy volunteers, as determined by medical history, physical examination (PE), vital
             signs, and clinical safety laboratory examinations.

          -  Able to comprehend the study requirements, agree to its provisions, have the ability
             to adhere to the provisions of the study, and give written informed consent prior to
             study entry.

          -  Willing to receive the unlicensed (VAX125) vaccine given as an i.m. injection.

          -  Willing to provide multiple blood specimens collected by venipuncture.

        Exclusion Criteria:

          -  Persons who in the opinion of the Investigator, have a psychiatric illness, a chronic
             illness (e.g., diabetes or liver or kidney disease), or who are taking a concomitant
             therapy or have any other condition that would interfere with the subject's
             participation in the study or interpretation of the study results.

          -  Persons having cancer or have received treatment for cancer within three years
             (persons with a history of cancer who are disease-free without treatment for three
             years or more are eligible.

          -  Persons with impaired immune responsiveness (of any cause), including diabetes
             mellitus.

          -  Persons presently receiving or having a recent history of receiving (within the past
             six months) any medication or therapeutic modality that affects the immune system such
             as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy,
             cytotoxic drugs or drugs known to be frequently associated with significant major
             organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical
             corticosteroids are allowed.

          -  Persons who have had a prior serious reaction to influenza vaccine.

          -  Persons with a history of anaphylactic-type reaction to injected vaccines.

          -  Persons with a history of drug or chemical abuse in the year prior to screening.

          -  Persons currently participating in another research study involving study medications
             (drugs or vaccines) or who have participated within 30 days of vaccination.

          -  Persons who have received blood or blood products within eight weeks prior to
             vaccination or are planning to receive blood or blood products during the study
             period.

          -  Persons who have donated blood or blood products within eight weeks prior to
             vaccination or plan to donate at any time during the study.

          -  Persons with acute disease within 72 hours prior to vaccination defined as the
             presence of a moderate or severe illness as determined by the Investigator through
             medical history and physical examination. Vaccination can be delayed until the subject
             has recovered.

          -  Persons with significant cardiovascular disease e.g., New York Heart Associate (NYHA)
             Class 3 or 4 congestive heart failure; myocardial infarction within the past six
             months; unstable angina, coronary angioplasty within the past six months; uncontrolled
             ventricular cardiac arrhythmias; resting heart rate (HR) >100 beats per minute (bpm)

          -  Persons with a history of chronic obstructive pulmonary disease or history of other
             lung disease.