BioVaxys Technology Corp said a further study in humans shows that the delayed type hypersensitivity (DTH) response, the basis for CoviDTH, its disposable diagnostic tool that screens for T-cell immune response to SARS-CoV-2, is highly durable and persists for at least one year after coronavirus (COVID-19) exposure or vaccine administration.
Its Scientific Advisor for its CoviDTH program, Yvelise Barrios and Clinical Immunologist at Hospital Universitario de Canarias, Tenerife, Spain, presented the new clinical study entitled ‘Long term follow-up of in vivo cellular immune response to SARS-CoV-2 using delayed-type hypersensitivity cutaneous test’ at the 6th European Congress of Immunology held September 1-4, 2021.
ECI is one of the most highly-regarded international conferences in the field of basic and clinical immunology.
READ: BioVaxys says trial affirms CoviDTH approach to screen for T cell-mediated immune response to SARS-CoV-2 is effective in humans
Dr Barrios is a leading expert in the clinical use of DTH, the mechanism behind CoviDTH.
Her collaborators were Inmaculada Sanchez Machín and Victor Matheu, Allergology Department and Grupo de Expertos Inmunodeficiencias, Hospital Universitario de Canarias, Tenerife.
Their study shows that the DTH response, which is the basis for CoviDTH, in individuals who had recovered from COVID-19 is highly durable, persisting for at least one year after viral exposure in these preliminary data. They conclude that the DTH test can be used as a routine diagnostic method to monitor the T cell-mediated response to SARS-CoV-2.
Two recovered patients were tested for DTH at six and 12 months after infection. The DTH responses were considered very “large responses”, compared, for example, to the DTH responses of people with a history of tuberculosis.
These results pointed out that natural, acquired immunity in these two patients is still very clearly present after one year of follow-up and that the DTH is a very simple and easy to interpret test to answer questions about durability of cellular immune responses in COVID-19.
In June 2021, Dr Barrios and her colleagues had previous human studies of DTH published in the medical research journals Vaccines and Clinical Immunology, which validated the use of the CoviDTH approach of a DTH cutaneous test as a feasible and safe in vivo method to assess cellular immune responses in both natural and vaccinated SARS-CoV-2 exposed individuals.
There is significant evidence that an antibody-mediated and T cell-mediated immune response is required for protection against SARS-CoV-2 and that T cell-mediated immunity is a more reliable correlate of vaccine protection than antibody titers in seniors, strongly supporting the need for a determination of T cell response in COVID-19 vaccine design and population screening.
Kenneth Kovan, President and Chief Operating Officer of BioVaxys, said: "These human studies conducted by Dr. Barrios give us significant confidence in CoviDTH, especially as we now are preparing our IND for the planned US combined Phase I/II study."
For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.