title: Development of a Time and Cost Benefit Antibody Binding Test-Based Method for Determination of Rabies Vaccine Potency.
abstract: This study is an improvement on the antibody binding test, known as ABT method, to develop a simple and fast method in comparison with NIH for determination of rabies vaccine potency. In the current study, several commercial human and veterinary vaccines were tested using both modified ABT and NIH methods. The ED50was calculated using the probit method and the relative potency of each vaccine was measured based on the reference vaccine. The test was repeated four times to calculate the reproducibility of the method. Statistical analysis indicated that there was no significant difference between the result obtained from NIH and modified ABT method for either human or veterinary vaccines (p > 0.05). In addition, the linearity of the method (R2) was calculated as 0.94 by serial dilution of a test vaccine. Coefficient variances were determined as less than and more than 10% for the human and veterinary rabies vaccines, respectively. In conclusion, the findings suggest that the modified method could be considered as an alternative approach for rabies vaccine potency determination in in-process quality control tests at industrial scale. It is a time and cost benefit method and accuracy may further be increased by employing monoclonal antibodies against trimeric form of G glycoprotein. However, the use of serum samples may be useful compared with an artificial mix of antibodies because other components from the serum samples could have a positive impact on cell sensitivity and mimic more the complexity of the immune response. Although the modified test has solved a fundamental problem, it is still not sensitive enough for veterinary vaccine assessment and needs further modifications to obtain the acceptability criteria.
authors.affiliation: 1 Department of Immunology, School of Medicine, Tehran University of Medical Sciences , Tehran, Iran .|2 Department of Rabies, Virology Research Group, Pasteur Institute of Iran , Tehran, Iran .
authors.forename: Vahid
authors.initials: V
authors.lastname: Asgary
authors.affiliation: 3 Department of Immunology, School of Medicine, Iran University of Medical Sciences , Tehran, Iran .
authors.forename: Nazanin
authors.initials: N
authors.lastname: Mojtabavi
authors.affiliation: 2 Department of Rabies, Virology Research Group, Pasteur Institute of Iran , Tehran, Iran .
authors.forename: Alireza
authors.initials: A
authors.lastname: Janani
authors.affiliation: 4 Antimicrobial Resistance Research Center-Rasoul-e-Akram Hospital, Iran University of Medical Sciences , Tehran, Iran .
authors.forename: Tahereh
authors.initials: T
authors.lastname: Mousavi
authors.affiliation: 1 Department of Immunology, School of Medicine, Tehran University of Medical Sciences , Tehran, Iran .
authors.forename: Jamshid
authors.initials: J
authors.lastname: Hadjati
authors.affiliation: 2 Department of Rabies, Virology Research Group, Pasteur Institute of Iran , Tehran, Iran .
authors.forename: Mohammad Sadeq
authors.initials: MS
authors.lastname: Khosravy
authors.affiliation: 2 Department of Rabies, Virology Research Group, Pasteur Institute of Iran , Tehran, Iran .|5 Department of Pilot Nanobiotechnology, New Technology Research Group, Pasteur Institute of Iran , Tehran, Iran .
authors.forename: Reza
authors.initials: R
authors.lastname: Ahangari Cohan
mesh_terms: D000818:Animals; D000914:Antibodies, Viral / Q000378:metabolism*; D003362:Cost-Benefit Analysis; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D011485:Protein Binding; D011819:Rabies Vaccines / Q000276:immunology*; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods*; D013997:Time Factors; D064166:Vaccine Potency
chemical_list: D000914:Antibodies, Viral; D011819:Rabies Vaccines
keywords: ABT method; NIH method; rabies; vaccine potency