Universal Anti-Viral Vaccine for Healthy Elderly Adults (ALLOPRIME)

Safety and Efficacy of ALLOSTIM® Universal Anti-Viral Immunodulatory Vaccine for Healthy Elderly Adults

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, including possible protection against progression of the current outbreak of COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2 virus as well as protection from any future currently unknown newly emergent novel viruses.

Study Overview

• Status: Completed
• Conditions: Virus Diseases; Pneumonia; Influenza, Human; COVID-19 Respiratory Infection; ARDS, Human; RSV Pneumonia
• Intervention / Treatment: Drug: AlloStim

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 designed to create high titers of memory immune cells that are specific to the foreign antigens in the living cell vaccine. Upon encounter with any type of virus, these memory immune cells are activated and release cytokines including an immediate release of IFN-ϒ. This non-specific activation causes immune conditions similar to the conditions that occur in healthy younger patients that leads to rapid viral clearance and viral-specific memory immune response to clear infection and protect against recurrence.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Kim Demonte, LPN; Phone Number: 1-732-630-9059; Email: kcdemonte@hotmail.com
• Study Contact Backup: Name: Thu Bui, MHA; Phone Number: 1-619-227-4872; Email: thu@mirrorbio.com

Study Locations

• United States
  • Florida
    • Delray Beach, Florida, United States, 33445
      • Delray Physician Care Center
    • Miami, Florida, United States, 33186
      • Coral Research Clinic & Coral Diagnostic
    • Tampa, Florida, United States, 33615
      • Model Research
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccination; ID injection AlloStim Days 0, 3/4, 7, 10/11 and 14	Drug: AlloStim; Living, activated allogeneic Th1-like memory immune cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of vaccine events	vaccine events such as fever, rash, abnormal vital signs	day 0 to day 28
Proportion of subjects with positive T-cell response	measurement of Th1/Th2 balance, allo-specific Th1/CTL response	day 0 to 1 year
Proportion of subjects able to suppress viral propagation	ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B	day 0 to 1 year

Collaborators and Investigators

• Sponsor: Immunovative Therapies, Ltd.
• Collaborators: Mirror Biologics, Inc.
• Investigators: Study Director: David Fineberg, MD, Mirror Biologics, Inc.

Publications and helpful links

General Publications

• Har-Noy M, Or R. Allo-priming as a universal anti-viral vaccine: protecting elderly from current COVID-19 and any future unknown viral outbreak. J Transl Med. 2020 May 12;18(1):196. doi: 10.1186/s12967-020-02363-3.

Helpful Links

• sponsor website

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: elderly; COVID-19; AlloStim; universal viral vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Lung Diseases; Orthomyxoviridae Infections; COVID-19; Virus Diseases; Pneumonia; Influenza, Human; Respiratory Tract Infections; Respiratory Distress Syndrome
• Other Study ID Numbers: MBI-001-ALLOPRIME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No