Three Rs approaches in the production and quality control of fish vaccines

Midtlyng, Paul J.; Hendriksen, Coenraad; Balks, Elisabeth; Bruckner, L.; Elsken, Lawrence; Evensen, Øystein; Fyrand, Kjetil; Guy, Allison; Halder, Marlies; Hawkins, Penny; Kisen, Gunn; Romstad, Anne Berit; Salonius, Kira; Smith, Patrick B.; Sneddon, Lynne U.

doi:10.1016/j.biologicals.2011.02.001

Cited by 25 publications

(19 citation statements)

References 47 publications

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“…[23]. Hence alternative, equally effective methods that can rapidly provide estimates for protection and are in line with animal welfare for fish and 3Rs [24,25] are required.…”

Section: Plos Onementioning

confidence: 99%

A whole-cell Lactococcus garvieae autovaccine protects Nile tilapia against infection

et al. 2020

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The autovaccine was produced in-house using a bacterial isolate from a diseased fish from the target farm. Three groups of 150 fish each were injected with either 1) an oil-adjuvanted, inactivated whole cell autovaccine, 2) adjuvant only or 3) PBS (negative control). Approximately 660 degree days post vaccination, the fish were challenged with 9x10 5 cfu bacteria/ fish by intraperitoneal injection and monitored for a further 28 days. Protection against infections was measured by lack of/reduced bacterial loads both by bacterial re-isolation and immunohistochemistry as well as absence of clinical signs/pathology. Significantly less L. garvieae (p<0.03) was re-isolated from either the adjuvant only or control groups compared to the vaccinated group. Furthermore, a significantly high amount (p<0.001) of anti-L. garvieae specific antibodies were observed in the vaccinated group compared to the adjuvant only or control groups at time of challenge. This coincided with protection against infection measured by absence/reduced L. garvieae re-isolation from internal organs, reduced clinical signs and lack of pathology in this group. In the adjuvant only and control groups, bacteria were re-isolated from the kidney, liver, spleen, brain and eyes during the first 14 days. The findings suggest that oil-based vaccines can protect tilapia against L. garvieae infection through an antibody mediated response.

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“…[23]. Hence alternative, equally effective methods that can rapidly provide estimates for protection and are in line with animal welfare for fish and 3Rs [24,25] are required.…”

Section: Plos Onementioning

confidence: 99%

A whole-cell Lactococcus garvieae autovaccine protects Nile tilapia against infection

et al. 2020

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“…There is pressure to minimize the use of animal challenge studies [37], evaluating serological measures of protection instead [38] (box 2). Although serological studies are routinely used in the evaluation of veterinary vaccines, sero-conversion per se is rarely used as a measure of efficacy during licensure.…”

Section: Evaluating Protective Effects In Vaccinated Humans and Animalsmentioning

confidence: 99%

Veterinary and human vaccine evaluation methods

et al. 2014

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Despite the universal importance of vaccines, approaches to human and veterinary vaccine evaluation differ markedly. For human vaccines, vaccine efficacy is the proportion of vaccinated individuals protected by the vaccine against a defined outcome under ideal conditions, whereas for veterinary vaccines the term is used for a range of measures of vaccine protection. The evaluation of vaccine effectiveness, vaccine protection assessed under routine programme conditions, is largely limited to human vaccines. Challenge studies under controlled conditions and sero-conversion studies are widely used when evaluating veterinary vaccines, whereas human vaccines are generally evaluated in terms of protection against natural challenge assessed in trials or post-marketing observational studies. Although challenge studies provide a standardized platform on which to compare different vaccines, they do not capture the variation that occurs under field conditions. Field studies of vaccine effectiveness are needed to assess the performance of a vaccination programme. However, if vaccination is performed without central co-ordination, as is often the case for veterinary vaccines, evaluation will be limited. This paper reviews approaches to veterinary vaccine evaluation in comparison to evaluation methods used for human vaccines. Foot-and-mouth disease has been used to illustrate the veterinary approach. Recommendations are made for standardization of terminology and for rigorous evaluation of veterinary vaccines.

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“…the state of being moribund) generally refers to an animal ‘close to death’ 18 or in a ‘severely debilitated state that precedes imminent death’. 7,30 (Moribundity has also been defined as ‘being in state of dying or inability to survive, even if treated’ 3 which is a broader state and reflects progression beyond the point of no return (see below). )…”

Section: What Is the Moribundity End-point?mentioning

confidence: 99%

“…1–3 Prescribed regulatory tests for fish, such as those assessing the acute toxicity of chemicals 4 and the efficacy of vaccines, 5 are still based around a mortality end-point and are amongst the most severe experiments that use fish. 6 As opportunities for replacement and reduction in such prescribed tests are limited or have already been addressed, 7–9 the current focus is on refinement.…”

Section: Introductionmentioning

confidence: 99%

Clarification of early end-points for refinement of animal experiments, with specific reference to fish

Ellis

Katsiadaki

2020

Lab Anim

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Appropriate end-points are integral to the refinement of laboratory animal experiments. Our recent experience has highlighted that ambiguity around end-points is hampering their adoption in experiments that cause severe suffering to fish. In toxicology, the term endpoint (single word) refers to the response variable to the treatment that is measured and analysed. This differs to usage within laboratory animal experimentation, where end-point (hyphenated) refers to the time-point when exposure of the animal(s) to the treatment (and suffering) ends. Within laboratory animal experimentation, standardised terminology is needed for different types of early end-point which are based on the condition of the animal(s) or progress of the experiment. We propose that those involved in regulating and conducting animal experiments consider seven distinct types of early end-point (aim, technical error, biological error, mortality, moribundity, prognostic humane, non-prognostic humane) in addition to the planned experimental end-point (i.e. maximum duration). Moribundity (not morbidity) refers to an animal in a severely debilitated state close to death. Moribundity in fish is not yet defined, so we propose identification via a lack of response to external stimuli, loss of equilibrium (i.e. loss of righting reflex), and a slow opercular ventilation rate. As these clinical signs equate to those of deep/surgical anaesthesia, this moribundity end-point cannot be considered a humane end-point as the fish is likely to be unconscious and have passed the point of maximum suffering. We believe that identification of earlier humane end-points based on clinical signs and wider recognition of other types of early end-point can reduce suffering in experiments.

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Three Rs approaches in the production and quality control of fish vaccines

Cited by 25 publications

References 47 publications

A whole-cell Lactococcus garvieae autovaccine protects Nile tilapia against infection

A whole-cell Lactococcus garvieae autovaccine protects Nile tilapia against infection

Veterinary and human vaccine evaluation methods

Clarification of early end-points for refinement of animal experiments, with specific reference to fish

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