Two companies have presented a novel vaccination concept that might protect risk groups from new SARS-CoV-2 variants.
In contrast to all current vaccination approaches against SARS-Co-V-2, the approach of Mirror Biologics Inc., the US subsidiary of Jerusalem-based Immunovative Therapies Ltd., addresses the phenomenon of viral evolution. In the Journal of Translational Medicine, Michael Har-Noy and collegues describe the companies’ technical rationale for development of a universal anti-viral vaccine designed to protect immunocompromised humans and eldery adults from COVID-19 and any future novel virus outbreaks.
The patent-pending technology called „AlloPriming“ is designed so that a series of injections of bioengineered Th1-cells, called „AlloStim®, could provide protection from any future viral infection, including progression of the current outbreak of COVID-19 infection, and any future variants of the causative SARS-CoV-2 virus or the next ‘Disease X’. The technology primes the elderly immune system to respond to viruses in the same manner as a healthy younger adult immune system would respond – it remodels the aging immune system in order to reverse immunosenescence and protect against chronic inflammations. A Phase I/II clinical protocol has been prepared for testing this concept in healthy adults over 50 years in age and is currently under review by the US FDA.
The major focus for vaccine development against viruses are currently strategies that introduce inactivated whole viruses, or pieces of viruses, or viral genetic material to teach the immune system to make antibodies, which bind to the virus. The aim is to elicit antibodies which „neutralize“ the virus by blocking entry into host cells. According to the authors, allo-priming, which triggers call-based immunity, provides a back-up in case vaccination strategies to elicit neutralising antibody protection fails or fails to protect the vulnerable elderly population.
Allo-priming is performed using activated, intentionally mismatched, ex vivo differentiated and expanded living Th1-like cells (AlloStim®) derived from healthy donors. Preclinically, multiple intradermal injections of AlloStim® created a dominate titer of allo-specific Th1/CD8-T-cytotoxic memory cells in circulation, replacing the dominance of exhausted memory cells of the aged immune system. Upon viral encounter, by-stander activation of the allo-specific memory cells caused an immediate release of interferon gamma (IFN-ϒ), stopping viral transcription and leading to by-stander activation of innate cellular effector cells and activation of cross-reactive allo-specific CD8-T-cytotoxic lymphocytes.
“A youthful immune response is believed to be most capable of clearance of viral infections before the infection progresses to serious disease", said Reuven or, who co-authored the publication.
He sees the approach as complementary to current vaccination approaches. But in deed it is more:
All current vaccination approaches have not been successful in protecting against emergent viruses, such as HIV, hepatitis C, Zika, dengue and the pandemic SARS and MERS coronaviruses, which mutatate and adapt very rapidly to its hosts. In contrast to childhood diseases they will not provide lifelong protection because they are based on an approach viral evolution, which does not occur in pathogens such as measles or other childhood diseases. For this reason, current vaccine technology platforms may not timely produce a protective vaccine against COVID-19 or could result in a vaccine that becomes obsolete after a viral mutation.
What is currently widely ignored: traditional vaccines could make rapidly mutating and adapting pathogens more aggressive. Under normal conditions, viral pathogens never become extremely deadly because they only spread if most of their hosts survive the infection. As vaccines create a selection advantage for viruses, which could enter and reproduce themselves ultrarapidly in the host cell, they might trigger a kind of vaccine-driven evolution, which would make viruses more deadly and devasting – as postulated for the case of Marek's disease vaccines a neoplastic disease of poultry.
Lead author Michael Har-Noy commented: "While there is great optimism regarding current clinical trials investigating protective vaccines against COVID-19, there is a very real possibility that none of the vaccine candidates under investigation will prove to provide long-term protection from COVID-19, and some vaccine candidates may even make symptoms worse. Even in the event that an effective vaccine is timely developed, such a vaccine likely would not be as effective in providing protective immunity in the elderly. If allo-priming is proven to work as designed, a single series of shots could protect against the current pandemic as well as any future pandemic.“