Report on the international workshop on alternative methods for Leptospira vaccine potency testing: State of the science and the way forward

Stokes, William S.; Srinivas, Geetha; McFarland, Richard; Kulpa-Eddy, Jodie; Casey, Warren; Walker, Angela; Draayer, Hans; Sebring, R. W.; Brown, Karen; Balks, Elisabeth; Stirling, Catrina; Klaasen, Eric; Hill, R. E.; Rippke, Byron E.; Ruby, K.W.; Alt, David P.; Mukhopadhyay, Suman; Kojima, Hajime; Johnson, Nelson; Rinckel, Lori A.; Doelling, Vivian; Jones, Bonnie Scott

doi:10.1016/j.biologicals.2013.06.013

Cited by 11 publications

(6 citation statements)

References 37 publications

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“…ree mAbs were then selected for further evaluation. e criteria for their selection was based on the expression level of the protein or epitope and high immunoreactivity on antigen as indicated in iELISA [29,30]. e binding ratio represents the detection level of antigens trapped by the capture antibody.…”

Section: Discussionmentioning

confidence: 99%

Development and Evaluation of an Immuno-Capture Enzyme-Linked Immunosorbent Assay to Quantify the Mycoplasma capricolum subsp. capripneumoniae (Mccp) Protein in Contagious Caprine Pleuropneumonia (CCPP) Vaccine

Baziki

Charles

Nwankpa

et al. 2020

Veterinary Medicine International

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An effective contagious caprine pleuropneumonia (CCPP) vaccine is essential for the increased production of healthy goats in a cost-effective manner and the prevention of animal-to-animal transmission for both domestic animals and wildlife. Quality control of this vaccine ensures that a reliable supply of pure, safe, and potent batches is obtained. As part of this control, in vitro quantification of Mycoplasma capricolum subsp. capripneumoniae (Mccp) protein in the final vaccines is required before the CCPP vaccine undergoes batch release and certification. The current method used for quantification is based on the measurement of total protein using the bicinchonic acid (BCA) test. This method quantifies the total amount of protein in the vaccine including contaminant protein from media, which can lead to overestimation of the quantity of Mccp protein, resulting in reduced vaccine immunogenicity. An immuno-capture ELISA (ICE) was developed for specific detection and quantification of the Mccp antigen in the CCPP vaccine. As the ICE detects and measures the amount of antigen between two layers of antibodies, capture and detecting antibodies are required. Mouse monoclonal antibodies (mAbs) that detect the Mccp antigen were produced and characterized. One of these mAbs, Mccp-25, was used to develop the ICE as an unlabelled capture antibody and horseradish peroxidase conjugated detecting antibody. The ICE was standardized and evaluated using an internal reference sample, experimental CCPP vaccines and commercial CCPP vaccines. A comparison between the polymerase chain reaction (PCR) and ICE showed good correlation between the two assays. Also, an in vitro ICE method correlated well with an in vivo sero-conversion in goats that were vaccinated with selected test vaccines. The sensitivity of the ICE was estimated at 30 ng/ml.

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Section: Discussionmentioning

confidence: 99%

Development and Evaluation of an Immuno-Capture Enzyme-Linked Immunosorbent Assay to Quantify the Mycoplasma capricolum subsp. capripneumoniae (Mccp) Protein in Contagious Caprine Pleuropneumonia (CCPP) Vaccine

Baziki

Charles

Nwankpa

et al. 2020

Veterinary Medicine International

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“…In spite of the investigation of in vitro potency test of Leptospira vaccines, 9 , 17 the vaccination-challenge tests performed in hamster are still an important procedure for controlling these bacterins. Of the five commercially available leptospirosis bacterins produced for the immunization of bovidae or swine in Brazil, only two, vaccines B and D were found to be effective.…”

Section: Discussionmentioning

confidence: 99%

“…The industry should support researches in leptospiral vaccinology to improve the quality of the present vaccines and discovery new immunogenic strains, because it is known that vaccination is one of the most important tools to increase the reproduction rates in livestock. 9 …”

Section: Discussionmentioning

confidence: 99%

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Efficacy of leptospiral commercial vaccines on the protection against an autochtonous strain recovered in Brazil

Sonada

Azevêdo

Soto

et al. 2018

Brazilian Journal of Microbiology

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In swine and bovines, leptospirosis prevention and control is carried out via vaccination of susceptible animals using bacterins. However, the efficiency of leptospirosis vaccines has been questioned. This work aimed to investigate the potency of five leptospirosis vaccines sold commercially in Brazil, challenging the animals with one autochthonous strain of Leptospira, Canicola serovar, denoted LO4, isolated from swine. The standard protocol was followed, and renal carriers of Leptospira were identified among the surviving animals by culture and PCR. Of the five vaccines tested, only two proved effective. None of the surviving animals was positive by culture; however, one animal was positive by PCR. Three of the five vaccines sold commercially in Brazil for the immunization of swine or bovines failed the test of the efficacy to protect the vaccinated animals following challenge with an autochthonous Leptospira strain, Canicola serovar. The two vaccines provided protection against the renal carrier state in the surviving animals. The criteria used to produce leptospirosis bacterins sold commercially in Brazil must be reviewed. The industry should support researches on leptospiral vaccinology to improve the quality of the present vaccines and discover new immunogenic strains, because it is known that vaccination is one of the most important tools to increase the reproduction rates in livestock.

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“…However, emulsion and aluminum salt adjuvants may interfere with in vitro methods to evaluate the antigens of final products [102]. The following section describes how this problem can be circumvented by testing intermediary products before blending of antigens and adjuvants [103], by extracting the antigenic fraction from final products or by using in vitro methods that are not affected by adjuvants.…”

Section: Adjuvanted Vaccinesmentioning

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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Report on the international workshop on alternative methods for Leptospira vaccine potency testing: State of the science and the way forward

Cited by 11 publications

References 37 publications

Development and Evaluation of an Immuno-Capture Enzyme-Linked Immunosorbent Assay to Quantify the Mycoplasma capricolum subsp. capripneumoniae (Mccp) Protein in Contagious Caprine Pleuropneumonia (CCPP) Vaccine

Development and Evaluation of an Immuno-Capture Enzyme-Linked Immunosorbent Assay to Quantify the Mycoplasma capricolum subsp. capripneumoniae (Mccp) Protein in Contagious Caprine Pleuropneumonia (CCPP) Vaccine

Efficacy of leptospiral commercial vaccines on the protection against an autochtonous strain recovered in Brazil

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

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