Animals vaccine testing

The U.S. standard pertussis vacciae is used to standardize the potency of the whole ceU pertussis vacciae. The number of protective units Hi the vaccine is estimated for each lot from the results of simultaneous intracerebral mouse-protection tests of the vaccine being studied and the U.S. reference standard (14,17). The potency of the aceUular vaccines is estimated by then abUity to produce antibodies to the proteins Hi the vaccine Hi a mouse model. These vaccines also undergo a series of animal safety tests to ensure that the iaactivation and toxoiding steps were carried out correctiy (14,17). 

The relevance of the target-animal safety test for batch safety testing of vaccines for veterinary use EU... 

The strength of certain viral vaccines is expressed as international units (IU), which are based on animal potency tests (e.g., rabies vaccine). 

The quality control of both diphtheria and tetanus vaccines requires that the products are tested for the presence of free toxin, that is for specific toxicity due to inadequate detoxification with formalin, at the final-product stage. By this stage, however, the toxoid concentrates used in the preparation of the vaccines have been much diluted and, as the volume ofvaccine that can be inoculated into the test animals (guinea-pigs)... 

Viral vaccines present problems of safety testing far more complex than those experienced with bacterial vaccines. With killed viral vaccines the potential hazards are those due to incomplete virus inactivation and the consequent presence of residual live virus in the preparation. The tests used to detect such live virus consist of the inoculation of susceptible tissue cultures and of susceptible animals. The cultures are examined for cytopathic effects and the animals for symptoms of disease and histological evidence of infection at autopsy. This test is of particular importance in inactivated poliomyelitis vaccine, the vaccine being injected intraspinally into monkeys. At autopsy, sections of brain and spinal cord are examined microscopically for the histological lesions indicative of proliferating poliovirus. 

Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2004. Updated July 22, 2005. 

World Organization for Animal Health. Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2004. Updated July 22, 2005. http //www.oie.int/. January 2006. 

Much of the preclinical data generated with regard to these vaccines entailed the use of one of two animal model systems simian immunodeficiency virus infection of macaque monkeys and HIV infection of chimpanzees. Most of the positive results observed in such systems have been in association with the chimp-HI V model. However, no such system can replace actual testing in humans. 

The prophylactic antitumor efficiency was tested by injecting 12 mice twice in seven days with AVE 3 TRP-2 (10 pg TRP-2) and AVE 3 1826 CpG (1.3 pg CpG) intradermally the control group remained untreated. Seven days after the last immunization 2 x 10 B16 tumor cells in 200 pL HBSS were injected into the tail vein of each mouse. Twenty days after tumor inoculation, the animals were sacrificed and the metastases in the prepared lungs counted. As Table 2 shows, the liposomal vaccination has a significant effect on the tumor growth in comparison to untreated animals. This is also reflected by the visual appearance of the lungs (data not shown). 

Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals... 

We studied the response of the immune biosensor with WGA-treated transducer surface in the analysis of the blood serum of vaccinated animals, which had Ab titer 1 128-1 256 according to the data obtained from RID test. It was found that the response of the immune biosensor to the blood serum of the sick and vaccinated animals was considerably different. In case of the non-modified transducer surface no difference was observed. 

---