1993: Steere paves the way for LYMErix.

 

In the report "Antibody Responses to the Three Genomic Groups of Borrelia burgdorferi in European Lyme Borreliosis," Allen Steere used high passage strains. This means that the bugs have been cultured through many generations and in so doing, they have dropped the plasmid that is encoded with OspA and B. With LYMErix in early trials at the time, the only reason to do this would be to develop testing standards for efficacy trials, since you can't test for a disease using the same marker that would identify the vaccine antigen.

 

Steere also added the ELISA as a screening test, averaging the concentration signal between the very low Neuro-Lyme responders and the very high autoimmune knee and acrodermatitis responders. As a result, the new, Dearborn, 2-tiered cutoff for an ELISA, will exclude all neurologic cases and of course, most of the IgM responders--which, to Steere, meant persisting infection in 1986.

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