Acute and repeated dose intramuscular toxicity of GM3 cancer vaccine in SD rats. | [Pakistan Journal of Biological Sciences • 2005]

Author(s):

1. A. M. Bada: National Center for Laboratory Animals Breeding, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

2. A. Mancebo: National Center for Laboratory Animals Breeding, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

3. D. Fuentes: National Center for Laboratory Animals Breeding, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

4. B. Gonzalez: National Center for Laboratory Animals Breeding, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

5. O. Hernandez: National Center for Laboratory Animals Breeding, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

6. N. Subiros: National Center for Laboratory Animals Breeding, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

7. M. Arteaga: National Center for Laboratory Animals Breeding, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

8. J. Hernandez: National Center for Laboratory Animals Breeding, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

9. A. Casaco: Center of Molecular Immunology, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

10. A. Carr: Center of Molecular Immunology, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

11. L. E. Fernandez: Center of Molecular Immunology, 216 St, Siboney, Playa, CP 16040, Havana 11600, Cuba

Abstract:

GM3 is a ganglioside over-expressed in some tumors, but it is also an autoantigen present in normal mammalian tissues. A novel ganglioside-based cancer vaccine for the treatment of human breast and melanoma tumors was designed. Two studies were carried out to evaluate the toxicity of GM3 cancer vaccine: Acute and repeated dose intramuscular administration in SD rats. The objective of the present study was to determine the toxicity of the GM3 vaccine in rats after intramuscular administration of single and repeated doses after 14 days. All rats were inspected daily for clinical signs. Body weight and rectal temperature were measured during the administration of test article. Gross necropsy was performed on all animals at the end of study and histological examination was performed on tissues from the repeated dose study. Blood samples were collected for hematological and serum biochemical determinations at the repeated dose assay. There were no deaths significant differences in mean body weight and rectal temperature with treatment. A slight treatment-related decrease in hemoglobin and hematocrit was observed and the white blood cell and neutrophils were increased in the GM3 vaccine group. Total proteins and albumin were significantly decreased in the treated group. All treated rats showed tissue hardening and an inflammatory reaction around the administration site. Increases in spleen weights were observed in treated animals. No other tissues in any animal of the treated group showed signs of toxicological lesions. In conclusion, GM3 vaccine was found to have a low toxicity.

Page(s): 1045-1050

DOI: DOI not available

Published: Journal: Pakistan Journal of Biological Sciences, Volume: 8, Issue: 7, Year: 2005

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