Universal Anti-Viral Vaccine for Healthy Elderly Adults

NCT04441047 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: MBI-001-ALLOPRIME
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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, 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.

Conditions

Virus Diseases; Pneumonia; COVID-19 Respiratory Infection; RSV Pneumonia; Influenza, Human; ARDS, Human

Keywords

universal viral vaccine; COVID-19; AlloStim; elderly

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Vaccination

EXPERIMENTAL

ID injection AlloStim Days 0, 3/4, 7, 10/11 and 14

Drug: AlloStim

Interventions

AlloStim DRUG

Living, activated allogeneic Th1-like memory immune cells

Vaccination

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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)
• 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.

Sponsors & Collaborators

• Mirror Biologics, Inc.: lead

Study Sites (4)

Delray Physician Care Center

Delray Beach, Florida, 33445, United States

Location

Coral Research Clinic & Coral Diagnostic

Miami, Florida, 33186, United States

Location

Model Research

Tampa, Florida, 33615, United States

Location

Florida Medical Clinic, LLC

Zephyrhills, Florida, 33542, United States

Location

Related Publications (2)

• 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.

  PMID: 32398026 BACKGROUND

• Liu C, Yang X, Paoli-Bruno J, Sikes D, Marin-Ruiz AV, Thomas N, Shane R, Har-Noy M. Allo-Priming Reverses Immunosenescence and May Restore Broad Respiratory Viral Protection and Vaccine Responsiveness to the Elderly: Results of a Phase I/II Clinical Trial. Vaccines (Basel). 2025 Apr 25;13(5):463. doi: 10.3390/vaccines13050463.

  PMID: 40432075 DERIVED

Related Links

• sponsor website

MeSH Terms

Conditions

Virus Diseases; Pneumonia; Influenza, Human; Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Respiration Disorders; Pneumonia, Viral; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections

Study Officials

• Michael Har-Noy, MD

  Mirror Biologics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects over 65yo in two cohorts: ages 65-74 and age 75+

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 22, 2020
• Study Start: July 12, 2021
• Primary Completion: March 1, 2023
• Study Completion: November 1, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)