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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04441047
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : August 31, 2022
Sponsor:
Collaborator:
Mirror Biologics, Inc.
Information provided by (Responsible Party):
Immunovative Therapies, Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Virus Diseases Pneumonia COVID-19 Respiratory Infection RSV Pneumonia Influenza, Human ARDS, Human Drug: AlloStim Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects over 65yo in two cohorts: ages 65-74 and age 75+
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of ALLOSTIM® Universal Anti-Viral Immunodulatory Vaccine for Healthy Elderly Adults
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : March 20, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. frequency of vaccine events [ Time Frame: day 0 to day 28 ]
    vaccine events such as fever, rash, abnormal vital signs

  2. Proportion of subjects with positive T-cell response [ Time Frame: day 0 to 1 year ]
    measurement of Th1/Th2 balance, allo-specific Th1/CTL response

  3. Proportion of subjects able to suppress viral propagation [ Time Frame: day 0 to 1 year ]
    ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441047


Contacts
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Contact: Kim Demonte, LPN 1-732-630-9059 kcdemonte@hotmail.com
Contact: Thu Bui, MHA 1-619-227-4872 thu@mirrorbio.com

Locations
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United States, Florida
Delray Physician Care Center Recruiting
Delray Beach, Florida, United States, 33445
Contact: Joane Seide    561-278-3134    joaneseide@delrayphysciancarecenter.com   
Principal Investigator: Nicole Thomas, MD         
Sub-Investigator: Lisa Kelso, MD         
Coral Research Clinic & Coral Diagnostic Recruiting
Miami, Florida, United States, 33186
Contact: Kimko Harada, CRC    786-362-6114    haradakimi.coral@gmail.com   
Principal Investigator: Jorge Paoli-Bruno, MD         
Model Research Recruiting
Tampa, Florida, United States, 33615
Contact: Susel Aluija, RN    813-304-1777    mresearch717@gmail.com   
Principal Investigator: Alejandra V Marin Ruiz, MD         
Florida Medical Clinic, LLC Recruiting
Zephyrhills, Florida, United States, 33542
Contact: William Johnston, RN    813-780-8368 ext 80150    wjohnston@floridamedicalclinic.com   
Principal Investigator: David Sikes, MD         
Sponsors and Collaborators
Immunovative Therapies, Ltd.
Mirror Biologics, Inc.
Investigators
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Study Director: David Fineberg, MD Mirror Biologics, Inc.
More Information
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Additional Information:

Publications:

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Responsible Party: Immunovative Therapies, Ltd.
ClinicalTrials.gov Identifier: NCT04441047    
Other Study ID Numbers: MBI-001-ALLOPRIME
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immunovative Therapies, Ltd.:
universal viral vaccine
COVID-19
AlloStim
elderly
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Virus Diseases
Influenza, Human
Respiratory Distress Syndrome
Infections
Pneumonia, Viral
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Orthomyxoviridae Infections
Respiration Disorders