Skip to main content

Design and Production of Single-Immunization Vaccines Using Polylactide Polyglycolide Microsphere Systems

  • Chapter

Part of the book series: Pharmaceutical Biotechnology ((PBIO,volume 6))

Abstract

Over the past several years, many new adjuvant formulations have been developed to elicit both humoral and cell-mediated responses to antigens. Each of these new formulations must be given in repeated immunizations to yield antibody titers that result in protection. Typically, a minimum of three immunizations is required to invoke antibody titers or cellular responses that are sufficient to neutralize an infection. In addition, the patient may be required to return several years after the last immunization for a final booster immunization to again establish a neutralizing response. These repeated immunizations in developed countries may require repeated visits to the physician and increase the cost of health care. In developing countries and large urban areas, clinics are responsible for immunization of the children against many potentially fatal childhood diseases. Unfortunately, these clinics may have difficulty with repeated immunizations, since the patient population is transient or patients do not understand the necessity for additional shots. Thus, vaccine preparations requiring repeated immunizations are generally inefficient and may not always be successful in preventing disease because of poor patient compliance.

This is a preview of subscription content, log in via an institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   74.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  • Almeidia, A. J., Alpar, H. O., Williamson, D., and Brown, M. R., 1992, Poly(lactic acid) microspheres as immunological adjuvants for orally delivered cholera toxin B subunit, Biochem. Soc. Trans. 20:316S.

    Google Scholar 

  • Alonso, M. J., Cohen, S., Park, T. G., Gupta, R. K., Siber, G. R., and Langer, R., 1993, Determinants of release rate of tetanus vaccine from polyester microspheres, Pharm. Res. 10:945–953.

    Article  PubMed  CAS  Google Scholar 

  • Anderson, K. P., Lucas, C., Hanson, C. V., Londe, H. F., Izu, A., Gregory, T., Ammann, A., Berman, P. W., and Eichberg, J. W., 1989, Effect of dose and immunization schedule on immune response of baboons to recombinant glycoprotein 120 of HIV-1, J. Infect. Dis. 160:960–969.

    Article  PubMed  CAS  Google Scholar 

  • Barkin, R. M., Samuelson, J. S., Gotlin, L. P., and Barkin, S. Z., 1985, Primary immunization with diphtheria-tetanus toxoids vaccine and diphtheria-tetanus toxoids-pertussis vaccine adsorbed: Comparison of schedules, Pediatr. Infect. Dis. 4:168–171.

    Article  PubMed  CAS  Google Scholar 

  • Beck, L. R., 1990, Mammal immunization, U.S. Patent 4,919,929.

    Google Scholar 

  • Birkinshaw, C., Buggy, M., Henn, G. G., and Jones, E., 1992, Irradiation of poly(D,L-lactide), Polym. Degrad. Stab. 38:249–253.

    Article  CAS  Google Scholar 

  • Cabasso, V. J., Louie, R. E., Lo, B., and Dobkin, M. B., 1978, Antibody levels following W138 rabies vaccine, Dev. Biol. Stand. 40:231–235.

    PubMed  CAS  Google Scholar 

  • Christenson, B., and Bottinger, M., 1991, Changes of the immunological patterns against measles, mumps, and rubella: A vaccination program studied 3 to 7 years after the introduction of a two-dose schedule, Vaccine 9:326–329.

    Article  PubMed  CAS  Google Scholar 

  • Cleland, J. L., and Langer, R., 1994, Formulation and delivery of proteins and peptides: Design and development strategies, in: Protein Formulations and Delivery (J. L. Cleland and R. Langer, eds.), ACS Books, New York, pp. 1–21.

    Chapter  Google Scholar 

  • Cleland, J. L., Powell, M. F., and Shire, S. J., 1993, Development of stable protein formulations: A close look at protein aggregation, deamidation, and oxidation, CRC Crit. Rev. Then Drug Carrier Syst. 10:307–377.

    CAS  Google Scholar 

  • Cleland, J. L., Powell, M. F., Lim, A., Barron, L., Berman, P. W., Eastman, D. J., Nunberg, J. H., Wrin, T., and Vennari, J. C., 1994, Development of a single-shot subunit vaccine for HIV-1, AIDS Res. Hum. Retroviruses 10:s21–s26.

    PubMed  CAS  Google Scholar 

  • Costantino, W. R., Langer, R., and Klibanov, A., 1994, Moisture-induced aggregation of lyophilized insulin, Pharm. Res. 11:21–29.

    Article  PubMed  CAS  Google Scholar 

  • Eldridge, J. H., Staas, J. K., Meulbroek, J. A., Tice, T. R., and Gilley, R. M., 1991a, Biodegradable and biocompatible poly(DL-lactide-co-glycolide) microspheres as an adjuvant for staphylococcal enterotoxin B toxoid which enhances the level of toxin-neutralizing antibodies, Infect. Immun. 59:2978–2986.

    PubMed  CAS  Google Scholar 

  • Eldridge, J. H., Staas, J. K., Meulbroek, J. A., McGhee, J. R., Tice, T. R., and Gilley, R. M., 1991b, Biodegradable microspheres as a vaccine delivery, Mol. Immunol. 28:287–294.

    Article  PubMed  CAS  Google Scholar 

  • Eppstein, D. A., and Schryver, B. B., 1990, Controlled release of macromolecular Polypeptides, U.S. Patent 4,962,091.

    Google Scholar 

  • Folkman, M. J., and Langer, R. S., 1983, Systems for the controlled release of macromolecules, U.S. Patent 4,391,797.

    Google Scholar 

  • Furr, B. J. A., and Hutchinson, F. G., 1992, A biodegradable delivery system for peptides: Preclinical experience with the gonadotropin-release hormone agonist Zoladex®, J. Control. Rel. 21:117–128.

    Article  CAS  Google Scholar 

  • Grandfils, C., Flandroy, P., Nuhant, N., Barbette, S., Jérome, R., Teyssié, P., and Thibaut, A., 1992, Preparation of poly (d,l) lactide microspheres by emulsion-solvent evaporation, and their clinical applications as a convenient embolic material, J. Biomed. Mater. Res. 26:467–479.

    Article  PubMed  CAS  Google Scholar 

  • Hageman, M. J., Bauer, J. M., Possert, P. L., and Darrington, R. T., 1992, Preformulation studies oriented toward sustained delivery of recombinant somatotropins, J. Agric. Food Chem. 40:348–355.

    Article  CAS  Google Scholar 

  • Haigwood, N. L., Nara, P. L., Brooks, E., Van Nest, G. A., Ott, G., Higgins, K. W., Dunlop, N., Scandella, C. J., Eichberg, J. W., and Steimer, K. S., 1992, Native but not denatured recombinant human immunodeficiency virus type 1 gp120 generates broad-spectrum neutralizing antibodies in baboons, J. Virol. 66:172–182.

    PubMed  CAS  Google Scholar 

  • Hardy, G. E., Hopkins, C. C., Linnemann, C. C., Hatch, M. H., Chambers, J. C., and Witte, J. J., 1970, Trivalent oral poliovirus vaccine: A comparison of two infant immunization schedules, Pediatrics 45:444–448.

    PubMed  Google Scholar 

  • Hartas, S. R., Collett, J. H., and Booth, C., 1992, The influence of gamma-irradiation on the release of melatonin from poly(lactide-coglycolide) microspheres, Proc. Int. Symp. Control. Rel. Bioact. Mater. 19:321–322.

    Google Scholar 

  • Haskill, J. S., and Hunt, J. W., 1967a, Radiation damage to crystalline ribonuclease: Identification of Polypeptide chain breakage in the denatured and aggregated products, Radiat. Res. 32:827–848.

    Article  PubMed  CAS  Google Scholar 

  • Haskill, J. S., and Hunt, J. W., 1967b, Radiation damage to crystalline ribonuclease: Importance of free radicals in the formation of denatured and aggregated products, Radiat. Res. 32:606–624.

    Article  PubMed  CAS  Google Scholar 

  • Hazrati, A. M., Lewis, D. H., Atkins, T. J., Stohrer, R. C., McPhillips, C. A., and Little, J. E., 1993, Salmonella enteritidis vaccine utilizing biodegradable microspheres, Proc. Int. Symp. Control. Rel. Bioact. Mater. 20:101–102.

    Google Scholar 

  • Heller, J., 1993, Polymers for controlled parenteral delivery of peptides and proteins, Adv. Drug Deliv. Rev. 10:163–204.

    Article  CAS  Google Scholar 

  • Hess, G., Hingst, V., Cseke, J., Bock, H. L., and Clemens, R., 1992, Influence of vaccination schedules and host factors on antibody response following hepatitis B vaccination, Eur. J. Clin. Microbiol. Infect. Dis. 11:334–340.

    Article  PubMed  CAS  Google Scholar 

  • Horacek, I., and Kudlacek, L., 1993, Influence of molecular weight on the resistance of polylactide fibers by radiation sterilization, J. Appl. Polym. Sci. 50:1–5.

    Article  CAS  Google Scholar 

  • Hutchinson, F. G., 1988, Continuous release pharmaceutical compositions, U.S. Patent 4,767,628.

    Google Scholar 

  • Jepson, M. A., Simmons, N. L., O’Hagen, D. T., and Hirst, B. H., 1994, Comparison of poly(DL-lactide-coglycolide) and polystyrene microsphere targeting to intestinal M cells, J. Drug Target. 1:245–249.

    Article  Google Scholar 

  • Jertborn, M., Svennerholm, A.-M., and Holmgren, J., 1993, Evaluation of different immunization schedules for oral cholera B subunit-whole cell vaccine in Swedish volunteers, Vaccine 11:1007–1012.

    Article  PubMed  CAS  Google Scholar 

  • Jones, A. J. S., Nguyen, T. H., Cleland, J. L., and Pearlman, R., 1994, New delivery systems for recombinant proteins — practical issues from proof of concept to clinic, in: Trends and Future Perspectives in Peptide and Protein Drug Delivery (V. H. L. Lee, M. Hashida, and Y. Mizushima, eds.), Harwood Academic, Amsterdam (in press).

    Google Scholar 

  • Just, M., Kanra, G., Bogaerts, H., Berger, R., Ceyhan, M., and Petre, J., 1991, Two trials of an acellular DTP vaccine in comparison with a whole-cell DTP vaccine in infants: Evaluation of two PT doses and two vaccination schedules, Dev. Biol. Stand. 73:275–283.

    PubMed  CAS  Google Scholar 

  • Just, M., Berger, R., Drechsler, H., Brantschen, S., and Glück, R., 1992, A single vaccination with an inactivated hepatitis A liposome vaccine induces protective antibodies after only two weeks, Vaccine 10:737–739.

    Article  PubMed  CAS  Google Scholar 

  • Kalpana, K. R., and Park, K., 1993, Biodegradable hydrogels in drug delivery, Adv. Drug Deliv. Rev. 11:59–84.

    Article  Google Scholar 

  • Kessler, D. A., 1992, The basis of the FDA’s decision on breast implants, N. Engl. J. Med. 326:1713–1715.

    Article  PubMed  CAS  Google Scholar 

  • Khan, M. Z. I., Opdebeeck, J. P., and Tucker, I. G., 1994, Immunopotentiation and delivery systems for antigens for single-step immunization: Recent trends and progress, Pharm. Res. 11:2–11.

    Article  PubMed  CAS  Google Scholar 

  • Langer, R., 1993, Polymer-controlled drug delivery systems, Acc. Chem. Res. 26:537–542.

    Article  CAS  Google Scholar 

  • Lewis, D. H., 1990, Controlled release of bioactive agents from lactide glycolide polymers, in: Drugs and the Pharmaceutical Sciences (M. Chasin and R. Langer, eds.), Vol. 45, Dekker, New York, pp. 1–42.

    Google Scholar 

  • Ludwig, N. H., and Bosvenue, R. J., 1982, Controlled release parasitic formulations and method, U.S. Patent 4,331,652.

    Google Scholar 

  • Ludwig, N. H., and Ose, E. E., 1981, Controlled release formulations and method of treatment, U.S. Patent 4,293,539.

    Google Scholar 

  • Marx, P. A., Compans, R. W., Gettie, A., Staas, J. K., Gilley, R. M., Mulligan, M. J., Yamshchikov, G. V., Chen, D., and Eldridge, J. H., 1993, Protection against vaginal SIV transmission with microencapsulated vaccine, Science 260:1323–1327.

    Article  PubMed  CAS  Google Scholar 

  • Miller, R. A., Brady, J. M., and Cutright, D. E., 1977, Degradation rates of oral resorbable implants (polylactates and polyglycolates): Rate modification with changes in PLA/PGA copolymer ratios, J. Biomed. Mater. Res. 11:711–719.

    Article  PubMed  CAS  Google Scholar 

  • Ogawa, Y., Yamamoto, M., Okada, H., Yashiki, T., and Shimamoto, T., 1988a, Anew technique to efficiently entrap leuprolide acetate into microcapsules of polylactic acid or copoly(lactic/glycolic) acid, Chem. Pharm. Bull. 36:1095–1103.

    Article  PubMed  CAS  Google Scholar 

  • Ogawa, Y., Yamamoto, M., Okada, H., Yashiki, T., and Shimamoto, T., 1988b, Controlled-release of leuprolide acetate from polylactic acid or copoly(lactic/glycolic) acid microcapsules: Influence of molecular weight and copolymer ratio of polymer, Chem. Pharm. Bull. 36:1502–1507.

    Article  PubMed  CAS  Google Scholar 

  • Ogawa, Y., Yamamoto, M., Okada, H., Yashiki, T., and Shimamoto, T., 1988c, In vivo release profiles of leuprolide acetate from microcapsules prepared with polylactic acids or copoly(lactic/glycolic) acids and in vivo degradation of these polymers, Chem. Pharm. Bull. 36:2576–2581.

    Article  PubMed  CAS  Google Scholar 

  • O’Hagen, D. T., Jeffery, H., and Davis, S. S., 1993, Poly(lactide-co-glycolide) microparticles as controlled release vaccines, Proc. Int. Symp. Control. Rel. Bioact. Mater. 20:59–60.

    Google Scholar 

  • Okada, H., Ogawa, Y., and Yashiki, T., 1987, Prolonged release microcapsule and its production, U.S. Patent 4,652,441.

    Google Scholar 

  • Okada, H., Inoue, Y., Heya, T., Ueno, H., Ogawa, Y., and Toguchi, H., 1991, Pharmacokinetics of once-a-month injectable microspheres of leuprolide acetate, Pharm. Res. 8:787–791.

    Article  PubMed  CAS  Google Scholar 

  • Pierce, N. F., 1984, Induction of optimal mucosal antibody responses: Effects of age, immunization route(s), and dosing schedule in rats, Infect. Immun. 43:341–346.

    PubMed  CAS  Google Scholar 

  • Preis, I., and Langer, R. S., 1979, A single-step immunization by sustained antigen release, J. Immunol. Methods 28:193–197.

    Article  PubMed  CAS  Google Scholar 

  • Reid, R. H., Boedeker, E. C., McQueen, C. E., Davis, D., Tseng, L. Y, Kodak, J., and Sau, K., 1993, Preclinical evaluation of microencapsulated CFA/II oral vaccine against enterotoxigenic E. coli, Vaccine 11:159–167.

    Article  PubMed  CAS  Google Scholar 

  • Serufo, J. C., Lima, M. G., Ribeiro, M. F. B., and Santos, J. L. D., 1987, Comparative study of schemes of preexposure vaccination against human rabies: Importance of the interval between doses and laboratory control, Cienc. Cult. (Sao Paulo) 39:193–197.

    Google Scholar 

  • Singh, M., Singh, O., Singh, A., and Talwar, G. P., 1992, Immunogenicity studies on diphtheria toxoid loaded biodegradable microspheres, Int. J. Pharm. 85:R5–R8.

    Article  CAS  Google Scholar 

  • Spenlehauer, G., Vert, M., Benoit, J. P., and Boddaert, A., 1989, In vitro and in vivo degradation of poly (D,L-lactide/glycolide) type microspheres made by solvent evaporation method, Biomaterials 10:557–563.

    Article  PubMed  CAS  Google Scholar 

  • Tice, T. R., Gilley, R. M., Eldridge, J. H., Staas, J. K., Hollingshead, M. G., and Shannon, W. M., 1991, Method of potentiating an immune response, U.S. Patent 5,075,109.

    Google Scholar 

  • Visscher, G. E., Robinson, R. L., Maulding, H. V., Fong, J. W., Pearson, J. E., and Argentieri, G. J., 1985, Biodegradation of and tissue reaction to 50:50 poly(DL-lactide-co-glycolide) microcapsules, J. Biomed. Mater. Res. 19:349–365.

    Article  PubMed  CAS  Google Scholar 

  • Visscher, G. E., Robinson, R. L., and Argentieri, G. J., 1987, Tissue response to biodegradable injectable microcapsules, J. Biomater. Appl. 2:118–131.

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 1995 Springer Science+Business Media New York

About this chapter

Cite this chapter

Cleland, J.L. (1995). Design and Production of Single-Immunization Vaccines Using Polylactide Polyglycolide Microsphere Systems. In: Powell, M.F., Newman, M.J. (eds) Vaccine Design. Pharmaceutical Biotechnology, vol 6. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-1823-5_18

Download citation

  • DOI: https://doi.org/10.1007/978-1-4615-1823-5_18

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4613-5737-7

  • Online ISBN: 978-1-4615-1823-5

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics