Clinical Trials Directory

Trials / Completed

CompletedNCT04441047

Universal Anti-Viral Vaccine for Healthy Elderly Adults

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Mirror Biologics, Inc. · Industry
Sex
All
Age
65 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGAlloStimLiving, activated allogeneic Th1-like memory immune cells

Timeline

Start date
2021-07-12
Primary completion
2023-03-01
Completion
2024-11-01
First posted
2020-06-22
Last updated
2025-01-14

Locations

4 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04441047. Inclusion in this directory is not an endorsement.