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Thursday, 01. January 2009 /

New Method for Screening Tetanus Vaccine Toxicity

In the years 2009- 2011, Animalfree Research partially financed the optimization of an ex ante developed test which was believed to be able to discriminate between toxic and nontoxic batches of tetanus.


Project title:

New Method for Screening Tetanus Vaccine Toxicity  

Project leader:

Karin Weisser, Beate Krämer  

Financial support: 30'000 Euro   
Project background:

Especially during the 19th century, tetanus was a widely spread infection, resulting in severe muscle spasms and death in many humans. The infection is caused by the bacterium Clostridium tetani, which usually penetrates into the organism through open wounds. The bacteria then produce a toxin which interferes with muscle contractions. Today, there are vaccines to protect humans and animals from the effects of the toxin. The tetanustoxin is manufactured, chemically inactivated and used for immunization. Compliant to European law, each batch of produced toxin must be tested on animals to confirm the efficacy of the inactivation and therefore the safety of the product.  

In the years 2009  - 2011, Animalfree Research partially financed the optimization of an ex ante developed test which can determine residual toxocity in vaccines, that is, distinguish between active and inactive tetanustoxin. In 2010, the group was awarded the animal welfare Award of BMELV for their "BINACLE" assay. Currently, there is an international ring study, involving 14 countries, with the aim of achieving official recognition of BINACLE.    

Milestones/Timeline:

2009-20111  

Publications:

Behrensdorf-Nicol H. A. et al. (2013): Binding and cleavage (BINACLE) assay for the functional in vitro detection of tetanus toxin: Applicability as alternative method for the safety testing of tetanus toxoids during vaccine production. Vaccine 31: 6247-6253.  

Behrensdorf-Nicol H.A., Weisser K., Krämer B. (2015): "BINACLE" assay for in vitro detection of active tetanus neurotoxin in toxoids. ALTEX. 2015;32(2):137-42. (Review)

 

https://www.pei.de/EN/research/groups/veterinary-medicine/3r-approaches-product-testing/3r-approaches-in-product-testing-content.html?nn=8895686#anker1

 

Updates:

The test has been successfully adapted to botulinum toxin, and has the potential to replace highly distressful animal experiments (LD50), affecting several hundreds of thousands of animals (mice) each year. For this, the group was awarded the Ursula M. Händel animal welfare award in 2016.  

 

 https://www.pei.de/EN/information/journalists-press/press-releases/2016/15-dfg-grant-award-for-method-to-replace-animal-tests.html

Keywords: