Status:
COMPLETED
Universal Anti-Viral Vaccine for Healthy Elderly Adults
Lead Sponsor:
Mirror Biologics, Inc.
Conditions:
Virus Diseases
Pneumonia
Eligibility:
All Genders
65+ years
Phase:
PHASE1
PHASE2
Brief Summary
This protocol tests the safety and efficacy of a novel universal vaccine concept called "allo-priming" which is designed to protect elderly adults from progression of any type of viral infection, incl...
Detailed Description
The proposed Allo-Prime universal viral protection mechanism involves vaccination with a bioengineered living allogeneic cellular vaccine (AlloStim) derived from healthy blood donors. The vaccine is d...
Eligibility Criteria
Inclusion
- Males and females who are at least 65 years of age at time of enrollment
- Good general health \*
- 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.
- Normal EKG
- Available for the duration of the study
- Peripheral veins suitable for blood draw
- Able to provide consent
Exclusion
- 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.
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04441047
Start Date
July 12 2021
End Date
November 1 2024
Last Update
January 14 2025
Active Locations (4)
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1
Delray Physician Care Center
Delray Beach, Florida, United States, 33445
2
Coral Research Clinic & Coral Diagnostic
Miami, Florida, United States, 33186
3
Model Research
Tampa, Florida, United States, 33615
4
Florida Medical Clinic, LLC
Zephyrhills, Florida, United States, 33542