Potency, immunogenicity, and efficacy of rabies vaccine: In vitro and in vivo approach

Abstract Background Rabies, a potentially lethal virus, affects more than 150 countries. Although the rabies vaccine and immunoglobulin have been available since 1908, Bangladesh is new to vaccine manufacturing. We checked the quality of the local manufacturing rabies vaccine for substandard. Method...

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Main Authors: Fahima Akter, Md. Shamimuzzaman
Format: Article
Language:English
Published: Wiley 2024-02-01
Series:Immunity, Inflammation and Disease
Subjects:
Online Access:https://doi.org/10.1002/iid3.1198
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author Fahima Akter
Md. Shamimuzzaman
author_facet Fahima Akter
Md. Shamimuzzaman
author_sort Fahima Akter
collection DOAJ
description Abstract Background Rabies, a potentially lethal virus, affects more than 150 countries. Although the rabies vaccine and immunoglobulin have been available since 1908, Bangladesh is new to vaccine manufacturing. We checked the quality of the local manufacturing rabies vaccine for substandard. Methods The potency and immunogenicity of 20 vaccines were analyzed by three in vivo and in vitro methods from March 2020 to May 2023. Single radial immunodiffusion, fluorescent antibody virus neutralization, and national institutes of health tests were carried out to evaluate the vaccine's efficacy to provide sufficient protection against the rabies virus. Results The potency of the rabies vaccine was determined by the in vitro SRID method by measuring glycoprotein content. An average of 16 articles from each batch was calculated. The minimum and maximum average mean values of the 20 batches were 5.058 and 5.346, respectively. The variance was calculated at 0.00566. We found a coefficient of variation (CV) between 9.36% and 14.80%. The 100% sample was satisfactory, as these samples had a potency of over 2.5 IU/mL. To observe immunogenicity, we applied the FAVN method for determining antibody titers. An average of 16 articles from every batch were counted to quantify antibody titers. The mean quantity of antibody titers ranged from 2.389 to 3.3875. The CV was slightly lower because of the dispersion of the data. At last, we performed an in vivo method, the NIH test method, to determine potency based on mortality rate. We found a mean value of 4.777 IU/SHD with a standard deviation of 1.13 IU/SHD. All 20 batches were found 100% satisfactory in the NIH test. Conclusion The study implies that the rabies human vaccines manufactured in Bangladesh are potent enough to provide sufficient immunogenicity. Our research is warranted testimony for healthcare providers who work to extirpate rabies.
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spelling doaj.art-a23123d1b7e546249c9884c40d3047702024-02-28T18:18:31ZengWileyImmunity, Inflammation and Disease2050-45272024-02-01122n/an/a10.1002/iid3.1198Potency, immunogenicity, and efficacy of rabies vaccine: In vitro and in vivo approachFahima Akter0Md. Shamimuzzaman1Department of Microbiology and Hygiene Bangladesh Agricultural University Mymensingh BangladeshDepartment of Microbiology Jashore University of Science and Technology Jashore BangladeshAbstract Background Rabies, a potentially lethal virus, affects more than 150 countries. Although the rabies vaccine and immunoglobulin have been available since 1908, Bangladesh is new to vaccine manufacturing. We checked the quality of the local manufacturing rabies vaccine for substandard. Methods The potency and immunogenicity of 20 vaccines were analyzed by three in vivo and in vitro methods from March 2020 to May 2023. Single radial immunodiffusion, fluorescent antibody virus neutralization, and national institutes of health tests were carried out to evaluate the vaccine's efficacy to provide sufficient protection against the rabies virus. Results The potency of the rabies vaccine was determined by the in vitro SRID method by measuring glycoprotein content. An average of 16 articles from each batch was calculated. The minimum and maximum average mean values of the 20 batches were 5.058 and 5.346, respectively. The variance was calculated at 0.00566. We found a coefficient of variation (CV) between 9.36% and 14.80%. The 100% sample was satisfactory, as these samples had a potency of over 2.5 IU/mL. To observe immunogenicity, we applied the FAVN method for determining antibody titers. An average of 16 articles from every batch were counted to quantify antibody titers. The mean quantity of antibody titers ranged from 2.389 to 3.3875. The CV was slightly lower because of the dispersion of the data. At last, we performed an in vivo method, the NIH test method, to determine potency based on mortality rate. We found a mean value of 4.777 IU/SHD with a standard deviation of 1.13 IU/SHD. All 20 batches were found 100% satisfactory in the NIH test. Conclusion The study implies that the rabies human vaccines manufactured in Bangladesh are potent enough to provide sufficient immunogenicity. Our research is warranted testimony for healthcare providers who work to extirpate rabies.https://doi.org/10.1002/iid3.1198FAVNimmunogenicityin vivo and in vitroNIHrabies vaccineSRID
spellingShingle Fahima Akter
Md. Shamimuzzaman
Potency, immunogenicity, and efficacy of rabies vaccine: In vitro and in vivo approach
Immunity, Inflammation and Disease
FAVN
immunogenicity
in vivo and in vitro
NIH
rabies vaccine
SRID
title Potency, immunogenicity, and efficacy of rabies vaccine: In vitro and in vivo approach
title_full Potency, immunogenicity, and efficacy of rabies vaccine: In vitro and in vivo approach
title_fullStr Potency, immunogenicity, and efficacy of rabies vaccine: In vitro and in vivo approach
title_full_unstemmed Potency, immunogenicity, and efficacy of rabies vaccine: In vitro and in vivo approach
title_short Potency, immunogenicity, and efficacy of rabies vaccine: In vitro and in vivo approach
title_sort potency immunogenicity and efficacy of rabies vaccine in vitro and in vivo approach
topic FAVN
immunogenicity
in vivo and in vitro
NIH
rabies vaccine
SRID
url https://doi.org/10.1002/iid3.1198
work_keys_str_mv AT fahimaakter potencyimmunogenicityandefficacyofrabiesvaccineinvitroandinvivoapproach
AT mdshamimuzzaman potencyimmunogenicityandefficacyofrabiesvaccineinvitroandinvivoapproach