Toxicological assessment of the cochleate derived from Neisseria meningitidis proteoliposome in Sprague Dawley rats

North American Journal of Medical Sciences

Volumn 4, Issue 3, 2012, Pages 135-140

  Infante Bourzac, Juan Francisco ^a   Sifontes Rodríguez, Sergio ^a   Arencibia Arrebola, Francisco Daniel ^a   Hernández Salazar, Tamara ^a   Fariñas Medina, Mildrey ^a   Pérez, Oliver ^a  

^a FINLAY INSTITUTE   (Cuba)

Author keywords

AFco1; Cochleate; Rat; Toxicity

Indexed keywords

AFCO1 COCHLEATE; BACTERIAL POLYSACCHARIDE; PLACEBO; PROTEOLIPOSOME; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; AUTOPSY; BODY WEIGHT; CONTROLLED STUDY; FEMALE; FLUID INTAKE; HISTOLOGY; MALE; NEISSERIA MENINGITIDIS; NONHUMAN; NOSE IRRITATION; PATHOLOGICAL ANATOMY; RAT; TOXICOLOGY;

EID: 84858412165     PISSN: None     EISSN: 19472714     Source Type: Journal    
DOI: 10.4103/1947-2714.93888     Document Type: Article

References (24)

1. McGhee JR, Kiyono H. Mucosal immunology. In: Paul WE, editor. Fundamental Immunology. Vol. 909. San Diego: Academic Press; 1998. p. 167-79.
2. Acevedo R, Gil D, del Campo J, Bracho G, Valdés Y, Pérez O. The adjuvant potential of synthetic alkylglycerols. Vaccine 2006;24 Suppl 2: S32-3.
3. Yamamoto N, St Claire DA Jr, Homma S, Ngwenya BZ. Activation of mouse macrophages by alkylglycerols, inflammation products of cancerous tissues. Cancer Res 1988;48:6044-9.
4. Lycke N. From toxin to adjuvant: The rational design of a vaccine adjuvant vector. CTA1-DD/ISCOM. Cell Microbiol 2004;6:23-32.
5. Pérez O, Bracho G, Lastre M, Mora N, del Campo J, Gil D, etal. Novel adjuvant based on a proteoliposome-derived cochleate structure containing native lipopolysaccharide as a pathogen-associated molecular pattern. Immunol Cell Biol 2004;82:603-10.
6. Del Campo J, Lastre M, Bracho G, Rodríguez T, Gil D, ZayasC, etal. Immunological evaluation of bacterial derived Cochleate and proteoliposome as mucosal adjuvants. Vaccine 2006;24:50-1.
7. Canadian Council on Animal Care. Laboratory rats. Guide to the care and use of experimental animals. Vol. 2. Ottawa, Ontario; 1993. p. 175-87.
8. ISO. Norm Part 10: Test for irritation and delayed hypersensitivity. Biological Evaluation of Medical Devises. ISO 10993/10; 2002. p. 26-33.
9. Sutkowski EM. Non Clinical Safety Assessment of Preventive Vaccines: The FDA Perspective. In: Proceeding of the Workshop on Non Clinical Safety Evaluation of Preventive Vaccines: Recent Advances and Regulatory Considerations. Vol. 1. Washington, DC; 2002. p. 203-82.
10. Ledwith B. The Relevance of Animal Studies for Non-Clinical Safety Assessment of Vaccines. In: Proceeding of the Workshop on Non Clinical Safety Assessment of Preventive Vaccines: Recent Advances and Regulatory Considerations Vol. 1. Washington, D.C; 2002. p. 546-666.
11. th meeting of the WHO Expert Committee on Biological Standardization, No. 54; 2003. p. 34-9.
12. ® vaccine in Sprague Dawley Rats. Vaccimonitor 2005;14:21-7.
13. ® vaccine in Sprague Dawley rats. Vaccimonitor 2004;13:11-6.
14. Infante JF, Sifontes S, Pérez V, Bracho G, Hernández T, Zayas C, etal. Study of immunogenicity and local toxicity of Neisseria meningitides cochleates in Sprague Dawley rats. Vaccimonitor 2009;18:1-7.
15. Sifontes S, Infante JF, Díaz D, López Y, Pérez M, Sosa E, etal. Repeated dose toxicity study of life attenuated oral Cholera vaccine in Sprague Dawley rats. Arch Med Res 2009;40:527-35.
16. Pritchett KR, Coming BF. Biology and Medicine of rats: In: Rueter JD, Suckow MA, editors. Laboratory Medicine and Management. Ithaca NY: International Veterinary Information Service; No B2503.0904. (Accessed September 29, 2004, at http://www.ivis.org).
17. Martín E, Nicolas GM. Nasal mucilliary clearance as a factor in nasal drug delivery. Adv Drug Deliv Rev 1998;29:865-85.
18. Johansen FE, Baekkevold ES, Carlsen HS, Farstad IN, Soler D, Brandtzaeg P. Regional induction of adhesion molecules and chemokine receptors explains disparate homing of human B cells to systemic and mucosal effector sites: Dispersion from tonsils. Blood 2005;106:593-600.
19. Wlaf JL. The Membranous epithelial (M) cell and the mucosal immune system. Annu Rev Med 1984;35:95-112.
20. López Y, Infante JF, Sifontes S, Díaz D, Pérez V, Año G, etal. Pharmacology and toxicology of an oral tablet whole-cell inactivated cholera vaccine in Sprague Dawley rats. Vaccine 2011;29:3596-9.
21. López Y, Sifontes S, Infante JF, Díaz D, Obaya M, Álvarez E, etal. Evaluation of toxicity by single dose of the Diphtheria-Tetanus Vaccine in Sprague Dawley rats. Vaccimonitor 2005;14:1-6.
22. Kuck D, Lau T, Leuchs B, Kern A, Müller M, Gissmann L, etal. Intranasal vaccination with recombinant adeno-associated virus type 5 against human papillomavirus type 16 L1. J Virol 2006;80:2621-30.
23. Pérez O, Bracho G, Lastre M, Zayas C, González D, Gil D, etal. Proteoliposome-derived Cochleate as an immunomodulator for nasal vaccine. Vaccine 2006;24 Suppl 2: S52-3.
24. Bracho G, Lastre M, del Campo J, Zayas C, González D, GilD, etal. Proteoliposome derived cochleate as novel adjuvant. Vaccine 2006;24 Suppl 2: S30-1.