Potency test to discriminate between differentially over-inactivated rabies vaccines: Agreement between the NIH assay and a G-protein based ELISA

Toinon, Audrey; Moreno, Nadège; Chausse, Heloise; Mas, Emilie; Nicolai, Marie Claire; Guinchard, Fabien; Jaudinaud, Isabelle; Guinet-Morlot, Françoise; Riou, Patrice; Manin, Catherine

doi:10.1016/j.biologicals.2019.05.004

Cited by 14 publications

(5 citation statements)

References 32 publications

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“…To solve these problems, vaccine batches could be altered intentionally, for example by exposure to stresses that may decrease the stability of a batch during the vaccine production process (e.g. decreased or increased pH, osmolality, temperature), by creating vaccines with reduced antigen content or a different composition, by deviating from the standard inactivation method, or by changing the degree of adsorption to adjuvants [11,34,41,57,124,126,127]. Importantly, altered batches should be representative for non-compliant batches that may realistically be produced as a result of disturbances in vaccine production processes.…”

Section: Altered Batches To Validate In Vitro Test Methodsmentioning

confidence: 99%

Overcoming scientific barriers in the transition fromin vivoto non-animal batch testing of human and veterinary vaccines

Biggelaar

Hoefnagel

Vandebriel

et al. 2021

Expert Review of Vaccines

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Introduction: Before release, vaccine batches are assessed for quality to evaluate whether they meet the product specifications. Vaccine batch tests, in particular of inactivated and toxoid vaccines, still largely rely on in vivo methods. Improved vaccine production processes, ethical concerns, and suboptimal performance of some in vivo tests have led to the development of in vitro alternatives.Areas covered: This review describes the scientific constraints that need to be overcome for replacement of in vivo batch tests, as well as potential solutions. Topics include the critical quality attributes of vaccines that require testing, the use of cell-based assays to mimic aspects of in vivo vaccine-induced immune responses, how difficulties with testing adjuvanted vaccines in vitro can be overcome, the use of altered batches to validate new in vitro test methods, and how cooperation between different stakeholders is key to moving the transition forward. Expert opinion: For safety testing, many in vitro alternatives are already available or at an advanced level of development. For potency testing, in vitro alternatives largely comprise immunochemical methods that assess several, but not all critical vaccine properties. One-to-one replacement by in vitro alternatives is not always possible and a combination of methods may be required.

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Section: Altered Batches To Validate In Vitro Test Methodsmentioning

confidence: 99%

Overcoming scientific barriers in the transition fromin vivoto non-animal batch testing of human and veterinary vaccines

Biggelaar

Hoefnagel

Vandebriel

et al. 2021

Expert Review of Vaccines

View full text Add to dashboard Cite

show abstract

“…The National Institutes of Health (NIH) established the NIH test, is a in vivo test which is used to evaluate the potency of the rabies vaccine. In this experiment, mice are first inoculated with rabies vaccine before being exposed to the RABV, to assess the level of protection provided by inactivated rabies vaccinations 19 …”

Section: Introductionmentioning

confidence: 99%

“…In this experiment, mice are first inoculated with rabies vaccine before being exposed to the RABV, to assess the level of protection provided by inactivated rabies vaccinations. 19 The study aimed to evaluate the quality and efficacy of Bangladeshi-manufactured rabies vaccines comparing with an internationally renowned brand. Are locally manufactured vaccines efficacious and reliable?…”

Section: Introductionmentioning

confidence: 99%

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

Akter,

Shamimuzzaman

2024

Immunity Inflam & Disease

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BackgroundRabies, 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.MethodsThe 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.ResultsThe 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.ConclusionThe 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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“…To solve these problems, vaccine batches could be altered intentionally, for example by exposure to stresses that may decrease the stability of a batch during the vaccine production process (e.g. decreased or increased pH, osmolality, temperature) [11,31,121,122], by creating vaccines with reduced antigen content [11,122] or a different composition [38], by deviating from the standard inactivation method [51,122,123], or by changing the degree of adsorption to adjuvants. Importantly, altered batches should be representative for noncompliant batches that may realistically be produced as a result of disturbances in vaccine production processes.…”

Section: Altered Batches To Validate In Vitro Test Methodsmentioning

confidence: 99%

Cell-based assays to assess the immunostimulatory capacity of poultry vaccines

Biggelaar¹

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The research described in chapters 2-6 was funded by the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115924 (VAC2VAC). This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation program and EFPIA. The contents of this article represent the authors' scientific conclusions and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.

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Potency test to discriminate between differentially over-inactivated rabies vaccines: Agreement between the NIH assay and a G-protein based ELISA

Cited by 14 publications

References 32 publications

Overcoming scientific barriers in the transition fromin vivoto non-animal batch testing of human and veterinary vaccines

Overcoming scientific barriers in the transition fromin vivoto non-animal batch testing of human and veterinary vaccines

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

Cell-based assays to assess the immunostimulatory capacity of poultry vaccines

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