Universal Anti-Viral Vaccine for Healthy Elderly Adults

Inclusion Criteria:

1. Males and females who are at least 65 years of age at time of enrollment

2. Good general health *

3. Clinical screening laboratory evaluations (white blood cell (WBC), hemoglobin (Hgb),
platelets (PLTs), alanine transaminase (ALT), aspartate transaminase (AST), creatinine
(Cr), alkaline phosphatase (ALP), total bilirubin (T. Bili), prothrombin time (PT),
and partial thromboplastin time (PTT)) are within acceptable normal reference ranges
at the clinical laboratory being used.

4. Normal EKG

5. Available for the duration of the study

6. Peripheral veins suitable for blood draw

7. Able to provide consent

Exclusion Criteria:

- 1. History of autoimmune disease 2. Currently being treated for cancer (other than
non-melanoma skin cancer) 3. History of COPD 4. Any clinical condition requiring
systemic steroids or any current immunosuppressive therapy 5. HIV positive or any
other type of immunodeficiency disorder 6. History of cardiac disease: congestive
heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy
(beta blockers or Digoxin are permitted) 7. Uncontrolled hypertension defined as SBP
≥130 and/or DBP ≥ 80 mm Hg 8. Active clinically serious infections (> grade 2 CTCAE)
9. History of organ transplant or tissue allograft 10. Oral temperature ≥99.0 degrees
Fahrenheit (37.2 degrees Celsius). 11. Pulse < 60 or >100 beats per minute. 12. Oxygen
saturation <96% 13. Uncontrolled concurrent serious medical or psychiatric illness 14.
History of blood transfusion reactions 15. Receipt of any type of influenza vaccine or
COVID19 vaccine last dose within two weeks of planned first study drug injection
(influenza vaccination after day 28 is permitted)

- As determined by medical history and physical examination to evaluate acute or
ongoing chronic medical diagnoses/conditions that have been present for at least
90 days, which would affect the assessment of safety of subjects. Chronic medical
diagnoses/conditions should be stable for the last 60 days (no hospitalizations,
emergency room (ER), or urgent care for condition or need for supplemental
oxygen). This includes no change in chronic prescription medication, dose, or
frequency as a result of deterioration of the chronic medical diagnosis/condition
in the 60 days before enrollment. Any prescription change that is due to change
of health care provider, insurance company, etc., or done for financial reasons,
and in the same class of medication, will not be considered a deviation of this
inclusion criterion. Any change in prescription medication due to improvement of
a disease outcome, as determined by the participating site principal investigator
(PI) or appropriate sub-investigator, will not be considered a deviation of this
inclusion criterion.

Subjects may be on chronic or as needed (prn) medications if, in the opinion of the
participating site PI or appropriate sub-investigator, they pose no additional risk to
subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a
worsening of medical diagnosis/condition. Similarly, medication changes subsequent to
enrollment and study vaccination are acceptable provided the change was not precipitated by
deterioration in the chronic medical condition, and there is no anticipated additional risk
to the subject or interference with the evaluation of responses to study vaccination.