Archives of Medical Research
Volume 40, Issue 7 , Pages 527-535 , October 2009

Repeated Dose Toxicity Study of a Live Attenuated Oral Cholera Vaccine in Sprague Dawley Rats

  • Sergio Sifontes-Rodríguez

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • Corresponding Author InformationAddress reprint requests to: Sergio Sifontes-Rodríguez, Centro de Bioactivos Quimicos, Universidad Central de Las Villas, Carretera a Camajuani, Km 5½, Santa Clara, Villa Clara, Cuba; Phone: (53) 42-281117; Fax: (53) 42-281130
    • ,
  • Juan Francisco Infante-Bourzac

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Daiyana Díaz-Rivero

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Yulieé López-Feria

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Merlin Pérez-Pérez

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Eligio Sosa-Roble

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Viviana Pérez-Amat

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Yamilé López-Hernández

      Affiliations

    • Department of Molecular Biology, Vice-Presidency of Research, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Eduardo Álvarez-Figueredo

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Juan Carlos Martínez-Rodríguez

      Affiliations

    • Department of Technological Development, Vice-Presidency of Development, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Mildrey Fariñas-Medina

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Tamara Hernández-Salazar

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Yolexis Tamayo-García

      Affiliations

    • Department of Bacteriology, Vice-Presidency of Quality Assurance, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Yolanda Valdés-Abreu

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Adriana Ponce-Collera

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba
    • ,
  • Niurka Rodríguez-Pérez

      Affiliations

    • Department of Animal Models and Preclinical Studies, Finlay Institute, Siboney, Playa, Habana, Cuba

Received 22 May 2009 ,Accepted 20 July 2009.

References 

  1. World Health Organization. Wkly Epidemiol Rec 2005;80:261–268.
  2. Talavera A, Pino Y, Castaño J, et al. Formulation in tablets of a cholera whole cell inactivated vaccine candidate. Vaccine. 2006;24:3381–3387
  3. Benítez JA, Silva A, García H, et al. Preliminary assessment of the safety and immunogenicity of a new CTXPhi-negative, hemagglutinin/protease-defective El Tor strain as a cholera vaccine candidate. Infect Immun. 1999;67:539–545
  4. Silva AJ, Benitez JA. Haemagglutinin/protease expression and mucin gel penetration in El Tor biotype Vibrio cholerae. Microbiology. 2003;149:1883–1891
  5. Viret JF, Favre D. Biosafety aspects of the recombinant live oral Vibrio cholerae vaccine strain CVD 103-HgR. Vaccine. 2004;22:2457–2469
  6. García H, Cedré B, Balmaceda T, et al. Selección de cepas atenuadas de Vibrio cholerae para la obtención de candidatos vacunales atenuados orales contra el cólera. Rev Cubana Med Trop. 2005;57:92–104
  7. Sutkowski E. Non-Clinical Safety Assessment of Preventive Vaccines, the FDA Perspective. Proc Workshop on Non-Clinical Safety Evaluation of Preventive Vaccines: Recent Advances and Regulatory Considerations. December 2, 2002; Arlington, VA.
  8. Voisin EM, Collins JM, Hoyle PC. Extrapolation of animal toxicity to humans: interspecies comparisons in drug development. Regul Toxicol Pharmacol. 1990;12:107–116
  9. Human Medicines Evaluation Unit. The European Agency for the Evaluation of Medicinal Products (EMEA). Note for Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines. London; 17 December 1997. Report No. CPMP/SWP/465/95.
  10. Sutkowski EM. Non-clinical Safety Evaluation of Preventive Vaccines—Regulatory Considerations. Business Briefing: Future Drug Discovery. 2003;34–37
  11. World Health Organization . Guidelines on Nonclinical Evaluation of Vaccines. WHO Technical Report Series. Adopted by the 54th meeting of the WHO Expert Committee on Biological Standardization. November 2003;17–21
  12. Thareert K, Potjanee S, Emsri P. Immunogenicity and protective role of three formulations of oral cholera vaccines. Vaccine. 1998;16:201–207
  13. Kollaritsch H, Cryz SJ, Lang AB, et al. Local and systemic immune responses to combined Vibrio cholerae CVD103-HgR and Salmonella typhi ty21a live oral vaccines after primary immunization and reimmunization. Vaccine. 2000;18:3031–3039
  14. Verdier F. Non-Clinical Safety Assessment of Preventive Vaccines, the Industry Perspective. Proceeding of the Workshop on Non-Clinical Safety Evaluation of Preventive Vaccines: Recent Advances and Regulatory Considerations; December 2, 2002; Arlington, VA.
  15. Charles River Laboratories, Inc. Charles River Labs—Research Models: Sprague Dawley Rat Informational Resources. http://www.criver.com/research_models_and_services/research_models/SASCO_Sprague_Dawley.html [16 May 2006].
  16. National Bio Resource Project for the Rat in Japan (http://www.anim.med.kyoto-u.ac.jp/nbr/strainsx/hematology_list.aspx) [12 April 2006].
  17. Pritchett KR. Biology and Medicine of Rats: International Veterinary Information Service, Ithaca, NY; 2004.
  18. Taconic Technical Library. Taconic Sprague Dawley Phenotyping. (http://www.taconic.com/addinfo/SD_phenotyping.htm) [12 May 2006].
  19. Blumberg DA, Lewis K, Chatfield P, et al. Pathophysiology of reactions associated with pertussis vaccine. Dev Biol Stand. 1991;73:289–295
  20. Glassroth J. Clinical considerations in designing trials of vaccines for tuberculosis. Clin Infect Dis. 2000;30:S229–S232
  21. Kaji M, Kaji M, Ohkuma K, et al. Phase 1 clinical tests of influenza MDP-virosome vaccine (KD-5382). Vaccine. 1992;10:663–667
  22. Wiersbitzky S, Reddemann H. Leukemoid reaction or leukosis after MMR preventive vaccination. Kinderarztl Prax. 1993;61:118–119
  23. Soderberg LS, Barnett JB. Leukopenia and altered hematopoietic activity in mice exposed to the abused inhalant, isobutyl nitrite. Exp Hematol. 1996;24:848–853
  24. Abraham P, Kanakasabapathy I, Dian BJ. Propylthiouracil attenuates acetaminophen-induced renal damage in the rat. Nephrology. 2005;10:588–593
  25. Aydogdu N, Yalcin O, Batcioglu K, et al. Effects of caffeic acid phenethyl ester on glycerol-induced acute renal failure in rats. Clin Exp Pharmacol Physiol. 1998;31:575–579
  26. Bihorac A, Akoglu E, Kullu S. Tetracycline-induced acute interstitial nephritis as a cause of acute renal failure. Nephron. 1999;81:72–75
  27. Joh K, Ohkawa K, Aizawa S. Induction of interstitial nephritis in rats by basement membrane of human origin. Acta Pathol Jpn. 1989;39:551–557
  28. Kamijo Y, Yoshimura K, Soma K. Effect of milk on intestinal fluid accumulation and renal injury following mercuric chloride ingestion in rats. J Appl Toxicol. 2004;24:129–134
  29. Karahan I, Yilmaz S, Ceribasi AO, et al. Protective effect of lycopene on gentamicin-induced oxidative stress and nephrotoxicity in rats. Toxicology. 2005;215:198–204
  30. Kitching AR, Semple T, Li M, et al. Experimental autoimmune anti-glomerular basement membrane glomerulonephritis: a protective role for IFN-gamma. J Am Soc Nephrol. 2004;15:1764–1774
  31. Kumar G, Kannan V, Pandian MR. Antihepatotoxic effect of beta-carotene on paracetamol induced hepatic damage in rats. Indian J Exp Biol. 2005;43:351–355
  32. Madhukar RB. Acute and subchronic (28-day) oral toxicity study in rats fed with novel surfactants. AAPS PharmSci. 2004;6:1–10
  33. Nandi D, Swarup D. Effect of cysteine, methionine, ascorbic acid and thiamine on arsenic-induced oxidative stress and biochemical alterations in rats. Toxicology. 2005;211:26–35
  34. Sener G, Yuksel M, Gedik N, et al. Hepatic fibrosis in biliary-obstructed rats is prevented by ginkgo biloba treatment. World J Gastroenterol. 2005;5444–5449
  35. Senthilkumar S, Manohar BM, Babu MS. Effect of squalene on cyclophosphamide-induced toxicity. Clin Chem Acta. 2006;11:335–342
  36. Sotiriadou S, Mougios V, Ch Trontzos, et al. Estrogen effect on some enzymes in female rats after downhill running. Physiol Res. 2003;52:743–778
  37. Tasduq SA, Gupta DK, Baleshwar M, et al. Reversal of fibrogenic events in liver by Emblica officinalis (fruit), an Indian natural drug. Biol Pharm Bull. 2005;28:1304–1306
  38. Alsharif NZ. Protective effects of vitamin A and vitamin E succinate against 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)-induced body wasting, hepatomegaly, thymic atrophy, production of reactive oxygen species and DNA damage in C57BL/6J mice. Basic Clin Pharmacol Toxicol. 2004;95:131–138
  39. Chen W, Austin JW, Shen H, et al. Low dose aerosol infection of mice with virulent type A Francisella tularensis induces severe thymus atrophy and CD4 + CD8+ thymocyte depletion. Microb Pathog. 2005;39:189–196
  40. Ding G, Kapasi AA, Reddy K, et al. Tubular cell senescence and expression of TGF-beta1 and p21 (WAF1/CIP1) in tubulointerstitial fibrosis of aging rats. Exp Mol Pathol. 2001;70:43–53
  41. Benedetti R, Massouh E, Flo J. Administration of one dose of cholera toxin induces a systemic immune response prior to a mucosal immune response by a direct presentation in the spleen. Immunol Lett. 1998;60:149–156
  42. Concha A, Castaneda E, Martinez M, et al. Safety and immunogenicity of oral killed whole cell recombinant B subunit cholera vaccine in Barranquilla, Colombia. Bull Pan Am Health Organ. 1995;29:312–321

PII: S0188-4409(09)00161-1

doi: 10.1016/j.arcmed.2009.09.003

Archives of Medical Research
Volume 40, Issue 7 , Pages 527-535 , October 2009

Article Tools

* Image Usage & Resolution