ArticleVaccines2025
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.
Article in Vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04441047 (Safety and Efficacy of ALLOSTIM® Universal Anti-Viral Immunodulatory Vaccine for Healthy Elderly Adults), which is not on this map. Cited by 2 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety and Efficacy of ALLOSTIM® Universal Anti-Viral Immunodulatory Vaccine for Healthy Elderly Adults
Who cites it
2 citing papers in PubMed.
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Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Respiratory viral infections pose a significant health problem that disproportionately affects the elderly. With the aging worldwide population being less responsive to protective vaccines, there is an urgent need for strategies that can protect the elderly from community-acquired viral infections. BACKGROUND/
objectivesAllo-priming is a novel immunomodulatory vaccine concept using allogeneic, living, activated Th1 cells that are rejected by the host, creating anti-alloantigen Th1 immunity, increasing Th1 titers. Th1 cells orchestrate cellular immunity, and the age-related decline in Th1 cells contributes to weakened cellular immune response in the elderly, which correlates with poor responsiveness to vaccines and increased susceptibility to respiratory viral infections. Increased Th1 cell titers in the elderly were hypothesized to reverse immunosenescence and restore cellular immune function. Restoration of cellular immune function was predicted to restore broad respiratory viral protection through a heterologous immune mechanism.
methodsA phase I/II, multi-center, open-label clinical trial was conducted in 40 healthy adults over 65 years of age to investigate the safety of allo-priming and the effects this vaccination strategy has on cellular immune function over time.
resultsAllo-priming had a benign safety profile and significantly increased the titers of circulating Th1 cells. The increase in Th1 cells was shown to provide broad, self-amplifying respiratory viral protection over time in an ex vivo cytopathic effect assay without additional vaccinations and without any viral antigens included in the formulation, as well acting to increase neutralizing antibody titers in low-responding individuals previously vaccinated for COVID-19.
conclusionsThese results provide support for an expanded clinical evaluation of this immunomodulatory vaccination strategy as a possible method to restore cellular immune competence to the elderly and provide broad heterologous immune protection from respiratory viral infections without the need for frequent vaccine re-formulations or booster shots (National Library of Medicine: NCT04441047).
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