Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old
Condition: Influenza Vaccine
MeSH terms: Influenza, Human
Intervention: Sing2016 M2SR H3N2 influenza vaccine; Placebo
Intervention description: This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.; This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Three Cohorts will be enrolled sequentially with safety data reviewed between enrollment of successive cohorts.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and
      immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered
      intranasally to a healthy adult population age 50 to 85 years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be willing and able to provide written informed consent.

          2. Cohort 1: age 50-64 years at time of enrollment; Cohorts 2 and 3: age 65 to 85 years
             at time of enrollment (signing of informed consent form).

          3. Subject 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

          4. Healthy adults and those with stable chronic conditions as determined by medical
             history, physical examination, vital signs, clinical safety laboratory examinations
             and clinical judgment of the investigator to be eligible for study inclusion.

          5. Women of child-bearing potential must agree to abstain from sexual intercourse or to
             correctly use an acceptable method of contraception from 30 days prior to vaccination
             until 30 days after the last study vaccination.

          6. Women of childbearing potential must have a negative urine pregnancy test within 24
             hours prior to vaccination with investigational product.

        Exclusion Criteria:

          1. Any acute or chronic physical or mental condition that would limit the subject's
             ability to complete the study, increase risk of study participation or participant, or
             may interfere with interpretation of study results as based on the assessment by the
             Investigator.

          2. 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.

          3. Abnormal screening hematology or chemistry value per the FDA Guidance: Toxicity
             Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative
             Vaccine Clinical Trials.

          4. Currently receiving, or planned to receive during the study, any immunosuppressive
             therapy.

          5. Had a flu-like illness, influenza treatment, influenza vaccination, or prophylactic
             influenza viral drug administered in the previous 6 months before investigational
             product administration.

          6. Females who are pregnant or nursing; non-vasectomized males, with female partners of
             child-bearing potential, who are unwilling to use a highly effective form of
             contraception from the time of enrollment through at least 28 after administration of
             the investigational product.

          7. History of receipt of any investigational vaccine within 28 days of visit 1 or
             investigational drug within the past six months. An exception is made for receipt of a
             Covid-19 vaccine whether licensed or under emergency use authorization (EUA) as long
             as the second dose was given at least 28 days prior to dosing with investigational
             vaccine.

          8. Acute febrile illness within 72 hours prior to investigational product vaccination

          9. Receipt of blood/plasma products or immunoglobulin within 6 months before
             administration of the investigational product or planned for during the period of
             study participation.

         10. Planned donation of blood or blood product of at least approximately 1 pint within 3
             months after investigational product administration.