Weimersheimer RJE, Loza RE

Language: English/Spanish
References: 24
Page: 313-316
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ABSTRACT

The objective of the following study was to determine the adequate doses of gamma radiation to inactivate a very common rabies vaccine used in Mexico (V-319 Acatlán strain), without damaging its antigenic capabilities and determining its stability and shelf life. The vaccine titre before irradiation was 10 7.3 LD 50% x ml in suckling mice. The vaccine was irradiated with four different levels of gamma radiation (Co-60) to inactivate the virus. Immunogenicity was tested with the US National Hygiene Institute (NIH) test, and complete inactivation was controlled inoculating the vaccine intracerebrally in 3 day suckling mice. The vaccine was tested with FAS 16 adjuvant and without it. With 3.5 Kgy, the relative potency was 4.189 U.I., and 8 out of 16 suckling mice died. With 5.8 Kgy it was 4.093 U.I., and two mice out of the 16 inoculated died; with 8.4 Kgy it was 3.141 U.I., and neither of the 16 inoculated mice died. With 9.3 Kgy it was 0.952 U.I., and the mice did not die but the titre was not sufficient according to the Mexican Federal Regulations. The vaccine without the adjuvant provided very low immunogenicity. Antigenic stability variation did not affect the level of inmunogenicity. The titre was always according to the WHO and the Mexican requirements, except with the dose of 9.3 Kgy of gamma radiation (Co-60). Total inactivation of the vaccine was achieved with 8.4 Kgy of radiation dose, and it provided a good level of protection (3.141 U.I.). Shelf life of this inactivated vaccine maintains a protection level above the required by the Mexican regulation (1.0 U.I.) even at 720 days of storage at 4°C.

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