PDF(Pubmed)
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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
背景：狂犬病，一种潜在的致命病毒,影响150多个国家。尽管狂犬病疫苗和免疫球蛋白自1908年以来就已经上市，但孟加拉国是疫苗生产的新产品。我们检查了当地生产的狂犬病疫苗的质量是否不合格。
方法：从2020年3月至2023年5月，通过三种体内和体外方法分析了20种疫苗的效力和免疫原性。单一放射免疫扩散，荧光抗体病毒中和，和国家健康检测机构进行了评估疫苗的功效，以提供足够的保护，以防止狂犬病病毒。
结果：通过体外SRID方法通过测量糖蛋白含量来确定狂犬病疫苗的效力。计算来自每个批次的16个制品的平均值。20批的最小和最大平均平均值分别为5.058和5.346。方差计算为0.00566。我们发现变异系数(CV)在9.36%和14.80%之间。100%样品是令人满意的,因为这些样品的效价超过2.5IU/mL。为了观察免疫原性，我们应用FAVN方法测定抗体滴度。对来自每个批次的平均16个物品进行计数以定量抗体滴度。抗体滴度的平均量范围为2.389至3.3875。由于数据的分散,CV略低。最后,我们进行了体内方法，NIH测试方法，根据死亡率确定效力。我们发现平均值为4.777IU/SHD，标准偏差为1.13IU/SHD。发现所有20个批次在NIH测试中100%令人满意。
结论：该研究表明，孟加拉国生产的狂犬病人疫苗的效力足以提供足够的免疫原性。我们的研究对于那些致力于消灭狂犬病的医疗保健提供者来说是有保证的。
方法：从2020年3月至2023年5月，通过三种体内和体外方法分析了20种疫苗的效力和免疫原性。单一放射免疫扩散，荧光抗体病毒中和，和国家健康检测机构进行了评估疫苗的功效，以提供足够的保护，以防止狂犬病病毒。
结果：通过体外SRID方法通过测量糖蛋白含量来确定狂犬病疫苗的效力。计算来自每个批次的16个制品的平均值。20批的最小和最大平均平均值分别为5.058和5.346。方差计算为0.00566。我们发现变异系数(CV)在9.36%和14.80%之间。100%样品是令人满意的,因为这些样品的效价超过2.5IU/mL。为了观察免疫原性，我们应用FAVN方法测定抗体滴度。对来自每个批次的平均16个物品进行计数以定量抗体滴度。抗体滴度的平均量范围为2.389至3.3875。由于数据的分散,CV略低。最后,我们进行了体内方法，NIH测试方法，根据死亡率确定效力。我们发现平均值为4.777IU/SHD，标准偏差为1.13IU/SHD。发现所有20个批次在NIH测试中100%令人满意。
结论：该研究表明，孟加拉国生产的狂犬病人疫苗的效力足以提供足够的免疫原性。我们的研究对于那些致力于消灭狂犬病的医疗保健提供者来说是有保证的。
