Evaluation of the intramuscular administration of Cervarix™ vaccine on fertility, pre- and post-natal development in rats

Reproductive Toxicology

Volumn 31, Issue 1, 2011, Pages 111-120

  Segal, Lawrence ^a   Wilby, Owen K ^b   Willoughby, Chris R ^b   Veenstra, Stéphane ^a   Deschamps, Marguerite ^a  

^a GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^b HUNTINGDON LIFE SCIENCES   (United Kingdom)

Author keywords

AS04; Cervarix ; Development; Fertility; HPV; MPL; Vaccine

Indexed keywords

WART VIRUS VACCINE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; FEMALE; FEMALE FERTILITY; FETUS; GESTATIONAL AGE; IMMUNE RESPONSE; NEWBORN; NONHUMAN; POSTNATAL DEVELOPMENT; POSTNATAL GROWTH; PRENATAL DEVELOPMENT; PRENATAL DRUG EXPOSURE; RAT; SEROLOGY; SPRAGUE DAWLEY RAT; SURVIVAL RATE; TOXICITY TESTING;

ALPHAPAPILLOMAVIRUS; ALUMINUM HYDROXIDE; ANIMALS; ANIMALS, NEWBORN; BODY WEIGHT; EMBRYO, MAMMALIAN; EMBRYONIC DEVELOPMENT; FEMALE; FERTILITY; FETAL DEVELOPMENT; INJECTIONS, INTRAMUSCULAR; LACTATION; LIPID A; LONGEVITY; MATERNAL EXPOSURE; PAPILLOMAVIRUS VACCINES; PREGNANCY; PRENATAL EXPOSURE DELAYED EFFECTS; RATS; RATS, SPRAGUE-DAWLEY; TOXICITY TESTS;

HUMAN PAPILLOMAVIRUS; RATTUS;

EID: 79551590059     PISSN: 08906238     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.reprotox.2010.09.001     Document Type: Article

References (36)

1. Smith J.S., Lindsay L., Hoots B., Keys J., Franceschi S., Winer R., et al. Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-analysis update. Int J Cancer 2007, 121:621-632.
2. Descamps D., Hardt K., Spiessens B., Izurieta P., Verstraeten T., Breuer T., et al. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Human Vaccines 2009, 5:332-340.
3. Paavonen J., Jenkins D., Bosch F.X., Naud P., Salmerón J., Wheeler C.M., et al. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet 2007, 369:2161-2170.
4. Paavonen J., Naud P., Salmerón J., Wheeler C.M., Chow S.-N., Apter D., et al. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet 2009, 374:301-314.
5. Harper D.M., Franco E.L., Wheeler C., Ferris D.G., Jenkins D., Schuind A., et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 2004, 364:1757-1765.
6. Harper D.M., Franco E.L., Wheeler C.M., Moscicki A.B., Romanowski B., Roteli-Martins C.M., et al. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet 2006, 367:1247-1255.
7. Wheeler C.M., Teixeira J., Romanowski B., De Carvalho N., Dubin G., Schuind A. High and sustained HPV-16 and 18 antibody levels through 6.4 years in women vaccinated with Cervarix™ (GSK HPV-16/18 AS04 vaccine). 26th annual meeting of the European Society for Paediatric Infectious Diseases 2008.
8. Deschuyteneer M., Elouahabi A., Plainchamp D., Plisnier M., Soete D., Corazza Y., et al. Molecular and structural characterization of the L1 virus-like particles that are used as vaccine antigens in Cervarix™, the AS04-adjuvanted HPV-16 and -18 cervical cancer vaccine. Human Vaccines 2010, 6:407-419.
9. Baldridge J.R., McGowan P., Evans J.T., Cluff C., Mossman S., Johnson D., et al. Taking a Toll on human disease: Toll-like receptor 4 agonists as vaccine adjuvants and monotherapeutic agents. Expert Opin Biol Ther 2004, 4:1129-1138.
10. Casella C.R., Mitchell T.C. Putting endotoxin to work for us: monophosphoryl lipid A as a safe and effective vaccine adjuvant. Cell Mol Life Sci 2008, 65:3231-3240.
11. Qureshi N., Takayama K., Ribi E. Purification and structural determination of nontoxic lipid A obtained from the lipopolysaccharide of Salmonella typhimurium. J Biol Chem 1982, 257:11808-11815.
12. Evans J.T., Cluff C.W., Johnson D.A., Lacy M.J., Persing D.H., Baldridge J.R. Enhancement of antigen-specific immunity via the TLR4 ligands MPL adjuvant and Ribi.529. Expert Rev Vaccines 2003, 2:219-229.
13. Breitburd F., Kirnbauer R., Hubbert N.L., Nonnenmacher B., Trin-Dinh-Desmarquet C., Orth G., et al. Immunization with viruslike particles from cottontail rabbit papillomavirus (CRPV) can protect against experimental CRPV infection. J Virol 1995, 69:3959-3963.
14. Christensen N.D., Reed C.A., Cladel N.M., Han R., Kreider J.W. Immunization with viruslike particles induces long-term protection of rabbits against challenge with cottontail rabbit papillomavirus. J Virol 1996, 70:960-965.
15. Jansen K.U., Rosolowsky M., Schultz L.D., Markus H.Z., Cook J.C., Donnelly J.J., et al. Vaccination with yeast-expressed cottontail rabbit papillomavirus (CRPV) virus-like particles protects rabbits from CRPV-induced papilloma formation. Vaccine 1995, 13:1509-1514.
16. Kirnbauer R., Chandrachud L.M., O'Neil B.W., Wagner E.R., Grindlay G.J., Armstrong A., et al. Virus-like particles of bovine papillomavirus type 4 in prophylactic and therapeutic immunization. Virology 1996, 219:37-44.
17. Suzich J.A., Ghim S.-J., Palmer-Hill F.J., White W.I., Tamura J.K., Bell J.A., et al. Systemic immunization with papillomavirus L1 protein completely prevents the development of viral mucosal papillomas. Proc Natl Acad Sci USA 1995, 92:11553-11557.
18. Giannini S.L., Hanon E., Moris P., Van Mechelen M., Morel S., Dessy F., et al. Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only. Vaccine 2006, 24:5937-5949.
19. Didierlaurent A.M., Morel S., Lockman L., Giannini S.L., Bisteau M., Carlsen H., et al. AS04, an aluminum salt- and TLR4 agonist-based adjuvant system, induces a transient localized innate immune response leading to enhanced adaptive immunity. J Immunol 2009, 183:6186-6197.
20. Kundi M. New hepatitis B vaccine formulated with an improved adjuvant system. Expert Rev Vaccines 2007, 6:133-140.
21. European Medicines Agency. Guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465/95); 1995. http://www.emea.europa.eu/pdfs/human/swp/046595en.pdf.
22. European Medicines Agency. Guideline on adjuvants in vaccines for human use (EMEA/CHMP/VEG/134716/2004); 2004. http://www.emea.europa.eu/pdfs/human/vwp/13471604en.pdf.
23. Food and Drug Administration. Guidance for industry: considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications; 2006. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074827.htm.
24. Verdier F., Barrow P.C., Burge J. Reproductive toxicity testing of vaccines. Toxicology 2003, 185:213-219.
25. Salewski E. Naunyn Schmied. Arch Exp Pathol Pharmacol 1964, 247:367.
26. Dawson A.B. Note on staining of the skeleton of cleared skeletal specimens with alizarin red S. Stain Technol 1926, 1:123-124.
27. Wilson J.G. Embryological considerations in teratology. Teratology: principles and techniques 1965, 251-277. University of Chicago Press, Chicago. J.G. Wilson, J. Warkany (Eds.).
28. McCormick J.B., Gusmao H.H., Nakamura S., Freire J.B., Veras J., Gorman G., et al. Antibody response to serogroup A and C meningococcal polysaccharide vaccines in infants born of mothers vaccinated during pregnancy. J Clin Invest 1980, 65:1141-1144.
29. O'Dempsey T.J., McArdle T., Ceesay S.J., Secka O., Demba E., Banya W.A., et al. Meningococcal antibody titres in infants of women immunised with meningococcal polysaccharide vaccine during pregnancy. Arch Dis Child Fetal Neonatal Ed 1996, 74:F43-F46.
30. Shahid N.S., Steinhoff M.C., Roy E., Begum T., Thompson C.M., Siber G.R. Placental and breast transfer of antibodies after maternal immunization with polysaccharide meningococcal vaccine: a randomized, controlled evaluation. Vaccine 2002, 20:2404-2409.
31. Pentsuk N., van der Laan J.W. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol 2009, 86:328-344.
32. Diehl K.H., Hull R., Morton D., Pfister R., Rabemampianina Y., Smith D., et al. A good practice guide to the administration of substances and removal of blood, including routes and volumes. J Appl Toxicol 2001, 21:15-23.
33. Carlson B.M. Human embryology & developmental biology 1999, Mosby, Inc., St. Louis, p. 420-42.
34. Warkany J. Congenital malformations-notes and comments 1971, Year Book Medical Publishers Inc., Chicago.
35. Solomon H.M., Wier P.J., Fish C.J., Hart T.K., Johnson C.M., Posobiec L.M., et al. Spontaneous and induced alterations in the cardiac membranous ventricular septum of fetal, weanling, and adult rats. Teratology 1997, 55:185-194.
36. Fleeman T.L., Cappon G.D., Hurtt M.E. Postnatal closure of membranous ventricular septal defects in Sprague-Dawley rat pups after maternal exposure with trimethadione. Birth Defects Res B 2004, 71:185-190.