Influence of Mouse Strain on the Assayed Potency (Unitage) of Tetanus Toxoid

Hardegree, M. C.; Pittman, Margaret; Maloney, Clifford J.

doi:10.1128/aem.24.1.120-126.1972

Cited by 22 publications

(3 citation statements)

References 8 publications

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“…A similar effect of the mouse strain used has also been described for potency testing on tetanus toxoid. 19,20 Unfortunately, only limited information is available of laboratories using the same strain (and genotype) of mice. It must also be envisaged that for technical reasons, international standardization in animal use is an unrealistic and unreachable goal.…”

Section: Discussionmentioning

confidence: 99%

“…In the HS test, groups of mice (5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20) were injected intraperitoneally with serial dilutions of the vaccine to be tested. Four to 5 days after injection animals were challenged intraperitoneally with 0⋅5 ml of diluted histamine solution and the number of non-surviving mice in a prescribed observation period was recorded.…”

Section: Histamine Sensitisation Test (Hs)mentioning

confidence: 99%

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Collaborative Study on Test Systems to Assess Toxicity of Whole Cell Pertussis Vaccine

et al. 1997

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Section: Discussionmentioning

confidence: 99%

Section: Histamine Sensitisation Test (Hs)mentioning

confidence: 99%

Collaborative Study on Test Systems to Assess Toxicity of Whole Cell Pertussis Vaccine

et al. 1997

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“…The main objectives of the validation study were to replace the toxin challenge with in vitro estimations of tetanus antibodies, to replace the multi-dilution (quantitative) test with a single-dilution (qualitative) test, and to use guinea-pigs instead of mice, which would overcome the great differences found among strains of mice with regard to their antibody response to tetanus toxoid (27,28). In addition, guinea-pigs would provide adequate amounts of antiserum, so the model could be used for testing various vaccine components, and in particular, diphtheria toxoid.…”

Section: Prevalidation and Validation Of An Elisa And The Toxin Bindimentioning

confidence: 99%

ECVAM's Contributions to the Implementation of the Three Rs in the Production and Quality Control of Biologicals

et al. 2002

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A summary is presented of the activities initiated, and the progress achieved, between April 1993 and December 2001 in implementing the Three Rs in one of the main priority areas of the European Centre for the Validation of Alternative Methods (ECVAM) — the production and quality control of biologicals. These have included organising eight key workshops, and financial contributions to, and sponsorship of, relevant international workshops, symposia and conferences. Noteworthy activities include financial support and/or participation in a number of prevalidation and validation studies. These involved alternative methods for the batch potency testing of: human tetanus vaccines; human and veterinary tetanus antisera and immunoglobulin; rabies vaccines; Leptospira hardjo vaccines; Clostridium perfringens vaccines; and erysipelas vaccines. They also involved a cell culture test for specific toxicity testing of diphtheria toxoid vaccines. In addition, ECVAM funded a study on the use of humane endpoints for vaccine quality control tests involving severe suffering, such as the potency testing of erysipelas, rabies and pertussis vaccines. ECVAM has also contributed financially to the compilation of manuals and expert reports, and to training in test methods. Following the report of an ECVAM Task Force, ECVAM financially supported the prevalidation of some in vitro methods for the potency testing of a recombinant hormone. A proposal is presented for promotion of regulatory acceptance, and suggestions are made for possible future activities.

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A five‐year study of tetanus in the Cayo Santiago rhesus monkey colony: Behavioral description and epizootiology

Rawlins

Kessler

1982

American J Primatol

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Tetanus is a major cause of death in the free-ranging rhesus monkey colony on the island of Cay0 Santiago, Puerto Rico. During the five-year period of observation (July 1,1976 through June 30,1981, the mean annual tetanus mortality rate (+ 1 SD) was 1.74% ( + 0.15). The mean annual total mortality rate was 6.77% (&0.78). The tetanus mortality rate varied significantly (P < 0.005) among the six troops on the island. Clinically confirmed tetanus accounted for 24.68% of the 231 deaths which occurred on the island during the study. Although the base population increased from 479 to 914 monkeys or 90.8% in five years, there were no significant changes in either the total or the tetanus mortality rates. The mean age of tetanus deaths was 6.9 years ( f 3.9) in the males and 7.1 years ( * 5.4) in females. The mean age-specific tetanus mortality rate increased with age. Of the 67 confirmed tetanus cases, 57 proved fatal (26 males, 31 females) for a case fatality rate of 85.1 %. There was no significant sex difference in the tetanus mortality rate. No confirmed cases of neonatal tetanus were observed. Infection of juveniles and adults of both sexes occurred chiefly through septic wounds, but postpartum infection of females was also noted. The peak incidence of tetanus deaths for both sexes occurred during the mating season of the annual reproductive cycle, as a consequence of increased levels of aggression and subsequent wounding. The diagnosis of tetanus was based solely on the clinical signs and was characterized by early behavioral abnormalities consisting of torpor, reluctance to interact with other animals, inability to prehend food, inordinate thirst, difficulty in swallowing, progressive stiffening and adduction of the pectoral limbs, bipedal running, "kangaroo hopping," "toppling over," and pilo-erection. As the disease advanced, severely affected individuals developed the classic human triad of tetanus symptomato1ogy:trismus (lockjaw), extensor rigidity, and opisthotonus, which progressed in most cases to status epilepticus and death from respiratory paralysis or physical exhaustion. The course of the disease in fatal cases ranged in duration from 24 hours to ten days. Obese monkeys with mild cases of tetanus were the most likely to recover with some taking as long as a month to return to normal condition and regain body weight. Of ten recoveries, six were female and four male. Multiple cases were observed in one adult male, indicating that previous infections do not necessarily confer immunity to future attacks. Survivors did not have demonstrable antitoxin titers to Clostridium tetani toxin, thus con-

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Influence of Mouse Strain on the Assayed Potency (Unitage) of Tetanus Toxoid

Cited by 22 publications

References 8 publications

Collaborative Study on Test Systems to Assess Toxicity of Whole Cell Pertussis Vaccine

Collaborative Study on Test Systems to Assess Toxicity of Whole Cell Pertussis Vaccine

ECVAM's Contributions to the Implementation of the Three Rs in the Production and Quality Control of Biologicals

A five‐year study of tetanus in the Cayo Santiago rhesus monkey colony: Behavioral description and epizootiology

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