AI Article Synopsis
- Pertussis vaccines protect infants from whooping cough, but their main antigen, pertussis toxin (PT), lacks adequate safety testing.
- The only accepted test, the histamine sensitization test, is an unreliable and lethal animal assay that may not fully capture PT's safety profile.
- The authors developed an in vitro safety test using human cell lines to analyze PT's clinical effects, aiming to improve safety evaluations for vaccines and provide a model for other similar testing scenarios.
Article Abstract
Pertussis vaccines are routinely administered to infants to protect them from whooping cough. Still, an adequate safety test for pertussis toxin (PT), one of the main antigens in these vaccines, is not available. The histamine sensitization test is currently the only assay accepted by regulatory authorities to test for the absence of active PT in vaccines. This is however, a lethal animal test with poor reproducibility. In addition, it is not clear whether the assumed underlying mechanism, i.e., ADP-ribosylation of G proteins, is the only effect that should be considered in safety evaluation of PT. The in vitro safety test for PT that we developed is based on the clinical effects of PT in humans. For this, human cell lines were chosen based on the cell types involved in the clinical effects of PT. These cell lines were exposed to PT and analyzed by microarray. In this review, we discuss the clinical effects of PT and the mechanisms that underlie them. The approach taken may provide as an example for other situations in which an in vitro assay based on clinical effects in humans is required.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4896582 | PMC |
| http://dx.doi.org/10.4161/hv.28001 | DOI Listing |
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