S.O.P.10: SAFETY TEST IN CATTLE

In addition to the safety test in laboratory animals, each batch of CBPP vaccine must be subjected to a safety test in cattle.

I. Materials

• 10 healthy Cattle from an area free from CBPP and that MUST NOT have been exposed to M. mycoides subsp. mycoides either through vaccination or natural infection. In addition each animal shall be at least 24 months old.
• CBPP vaccine
• Syringes and needles
• Disinfectant e.g. 70% Ethanol

II. Procedure

1. Reconstitute the content of a vial of CBPP vaccine using a suitable cold, sterile diluent (e.g. sterile distilled water, physiological saline or 1M magnesium sulphate solution) so that 1 ml of the diluted vaccine contains at least 10 field doses.

2. If the seed used to prepare the vaccine is T₁SR, inoculate 1 ml of the reconstituted vaccine subcutaneously into each of 10 cattle at the loose skin of the flank posterior to the scapula region. If the vaccine seed strain is T_1//44 the reconstituted vaccine under test is inoculated subcutaneously at the tail tip. 10 cattle which will serve as the controls are inoculated with 1 ml of reconstitution fluid.

3. Inoculated animals are observed for a period of at least 30 days. The rectal temperature of each animal is taken daily throughout the observation period. Similarly any signs suggestive of an infectious agent must be recorded and fully investigated in order to determine the causative agent. Record the findings.

4. A vaccine batch passes the test for safety if no unexpected clinical reaction is observed in inoculated animals. Usually there may be a transient inflammatory reaction localised at the inoculation site which resolves within 14 days. Such a reaction if it does occur should not be extensive.