Vaccine Potency - Human Use

Conventional
test method

Alternative Test Method

Last Reviewed
Name & Description Validation Status Regulatory Status Effect or Potential Effect on Animal Use
Lethal/paralytic challenge test in the batch potency testing of tetanus toxoid vaccines for human use
(Methods A and B in PhEur 2.7.8)
ELISA procedure for Batch Potency Testing of Tetanus Vaccines
Description and references
EU: Endorsed as valid by ECVAM (2000) EU: Accepted into PhEur (Method C, 2.7.8) (2003) Reduction
(single-dilution test instead of multi-dilution)

Refinement
(Does not rely on death as an endpoint)

May 2012
Toxin Binding Inhibition (ToBI) Test for Batch Potency Testing  of Tetanus Vaccines
Description and references
EU: Endorsed as valid by ECVAM (2000) EU: Accepted into PhEur (Method C, 2.7.8) (2003)
US: 21 CFR 610.10
Reduction
(single-dilution test instead of multi-dilution)

Refinement
(Does not rely on death as an endpoint)

May 2012
Lethal/Intradermal Challenge Test in the Batch Potency Testing of Diphtheria Vaccine
(Methods A and B in PhEur 2.7.6)
ELISA Procedure for Potency testing of Diphtheria Vaccines
Description and references
No information EU: Accepted into  PhEur Reduction Refinement May 2012
Vero Cell Assay for Potency testing of Diphtheria Vaccines
Description and references
EU: Norwegian Medicines Agency presently conducting validation EU: Accepted into  PhEur Reduction Refinement May 2012
Combination Tetanus and Diphtheria vaccines – separate serology tests  for each vaccine Tetanus and Diphtheria Serology test – single test for combination vaccine
Description and references
No information EU: Accepted into  PhEur Reduction May 2012
Potency Test of Hepatitis B Vaccine (Mouse) Serological Antigen Quantification
Description and references
No information EU: Accepted into PhEur (2.7.15) Reduction Refinement May 2012
Serological Potency Test of Poliomyelitis (inactivated) Vaccine (Rat) Antigen quantification
Description and references
No information EU: Accepted into PhEur Replacement May 2012
Lethal challenge test for Rabies Vaccine Single dilution assay
Description and references
No information EU: Accepted into PhEur Reduction May 2012
Humane Endpoints for Rabies Potency Testing
Description and references
US: ICCVAM initiative EU: Accepted in PhEur
US: Accepted (9 CFR 117.e)
Refinement May 2012

 

List of Abbreviations

Test Methods Categories

Toxicity
Dermal Tests
Vaccines