Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines
Condition: Influenza A
MeSH terms: Influenza, Human
Intervention: LD Sing2016 M2SR H3N2 influenza vaccine; MD Sing2016 M2SR H3N2 influenza vaccine; HD Sing2016 M2SR H3N2 influenza vaccine; LD Bris10 M2SR H3N2 influenza vaccine; Placebo
Intervention description: This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.; This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.; This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.; This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.; This group will receive saline placebo administered intranasally.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blind, placebo-controlled Phase 1 study evaluating the safety and immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 influenza vaccines delivered intranasally to healthy adults. Eligible subjects will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR at three dose levels, Bris10 M2SR at one dose level, or placebo in a 1:1:1:1:1 ratio.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults,
      18-49 years of age, inclusive, who are in good health and meet all eligibility criteria. The
      purpose of this dose escalation clinical study is to assess the safety,
      tolerability/reactogenicity, and immunogenicity of H3N2 M2SR investigational vaccines for
      prevention of influenza, when delivered at higher dosages or in two doses . Eligible subjects
      will be screened and randomized to receive two administrations 28 days apart of Sing2016 M2SR
      at three dose levels (low, medium, high), Bris10 M2SR at one dose level (low), or placebo in
      a 1:1:1:1:1 ratio. Study duration will be approximately 8 months with subject participation
      duration approximately 7 months. The primary study objective is to assess the safety and
      reactogenicity of a monovalent live single replication influenza H3N2 M2SR vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Give written informed consent to participate.

          2. Age 18 - 49 years old.

          3. Judged suitable by the PI, as determined by medical history, physical examination,
             vital signs, and clinical safety laboratory examinations.

          4. Willing to use oral, implantable, transdermal or injectable contraceptives, or sexual
             abstinence, from screening and until 28 days after second vaccine dose.

          5. Willing to adhere to the requirements of the study and willing and able to communicate
             with the Investigator and understand the requirements of the study.

        Exclusion Criteria:

          1. Abnormal screening hematology or chemistry value per the FDA Toxicity Guidance.

          2. Pulse rate or blood pressure outside the reference range for this study population and
             considered as clinically significant by the Investigator.

          3. Has an acute or chronic medical condition or history of a medical condition that, in
             the opinion of the Investigator, would render the study procedures unsafe or would
             interfere with the evaluation of the responses.

          4. Presence or clinically significant history of lung disease, asthma, chronic
             obstructive pulmonary disease (COPD), or otherwise poor lung function.

          5. Any confirmed or suspected immunosuppressive or immunodeficient state.

          6. Presence of household member or close personal or professional (i.e., healthcare
             worker) who is a child under one year of age; is pregnant; has known immunodeficiency
             or is receiving immunosuppressant medication; is undergoing or soon to undergo cancer
             chemotherapy; has been diagnosed with emphysema, COPD, or other severe lung disease
             and resides in a nursing home; and/or has received a bone marrow or solid organ
             transplant.

          7. Females who are pregnant or lactating.

          8. Acute febrile illness within 72 hours prior to vaccination.

          9. Any condition, in the opinion of the Investigator, (such as subjects who have
             medically high-risk conditions) that might interfere with the primary study objectives
             for safety of the study subject.