Poly (D,L-Lactide) glycolide polymer microsphere entrapped tetanus toxoid: safety evaluation in Wistar rats

Chaudhury, Mousumi; Sharma, Kumakshi; Giri, Dipak K.

doi:10.1177/096032719601500303

Cited by 9 publications

(4 citation statements)

References 8 publications

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“…Controlled-release TT-microparticles prepared by the same method have undergone detailed toxicological evaluation in rats (7,8) and have been shown to be free from any major side effects. These formulations have also been shown to be free from embryotoxicity and teratogenic effects in wistar rats.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity and protection in small-animal models with controlled-release tetanus toxoid microparticles as a single-dose vaccine

Singh

Wang

et al. 1997

Infect Immun

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Tetanus toxoid (TT) was encapsulated in microparticles prepared from polylactide-co-glycolide polymers by a solvent-evaporation technique. Combinations of small-and large-sized microparticles with controlled-release characteristics were used to immunize Sprague-Dawley rats, and the antibody responses were monitored for 1 year. For comparison, control groups of rats were immunized at 0, 1, and 2 months with TT adsorbed to alum. The antibody responses generated by the TT entrapped in microparticles were comparable to those generated by TT adsorbed to alum in control groups from 32 weeks onwards. Microparticles with a single entrapped antigen (TT) induced better antibody responses than microparticles with two antigens (TT and diphtheria toxoid) entrapped simultaneously. A combination vaccine consisting of TT adsorbed to alum and also entrapped in microparticles gave the best antibody responses. In an inhibition assay designed to determine the relative levels of binding of antisera to the antigens, the sera from the microparticle-and the alum-immunized animals showed comparable levels of binding. In addition, in a passive-challenge study with mice, TT adsorbed to alum and TT entrapped in microparticles provided equal levels of protection against a lethal challenge with tetanus toxin. An intradermal-challenge study was also performed with rabbits, which showed similar levels of protection in sera from alum-and microparticle-immunized animals at 4, 12, and 32 weeks after immunization.

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Section: Discussionmentioning

confidence: 99%

Immunogenicity and protection in small-animal models with controlled-release tetanus toxoid microparticles as a single-dose vaccine

Singh

Wang

et al. 1997

Infect Immun

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“…The cellular and antibody responses of mice to tetanus toxoid were compared after subcutaneous administration of the toxoid alone or incorporated into aluminum hydroxide and PLGA microspheres. The safety of a similar vaccine was demonstrated in rats (40).…”

Section: Systemic Immunizationmentioning

confidence: 98%

“…The combination of particles with different diameters and polymer composition in the same formulation has permitted to establish the concept of the single-dose vaccine (1), which can be programmed to mimic the reinforcement dosages, inducing protection with a minimal number of administrations ( Figure 2). Finally, PLA and its copolymers have proved to be biocompatible and produce little or no local or systemic toxicity (39,40).…”

Section: Poly-lactide-co-glycolide Microspheresmentioning

confidence: 99%

Poly-DL-lactide-co-glycolide microspheres as a controlled release antigen delivery system

Lima

Júnior

1999

Braz J Med Biol Res

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Successful vaccine application means maximum protection with minimal number of administrations. A rational development of vaccines involves studies of the nature of the antigen as well as of the adjuvant to be used to improve the immune responses. This has provided the impetus for studies to design the degradable devices and for different approaches to antigen delivery by different routes of administration. The development of controlled release systems based on polymeric devices that permit a sustained or pulsed release of encapsulated antigens has attracted much interest. Polymeric delivery systems consist of polymers that release their content continuously in a controlled manner over a period of time. The development of a biocompatible delivery system for parenteral administration offers several advantages in terms of immunoadjuvanticity over other compounds. It was found that, in contrast to other carriers, microspheres are more stable, thus permitting administration by the oral or parenteral route. In the present study, we describe the main characteristics and potentialities of this new immunoadjuvant for oral and parenteral administration. Correspondence

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“…Microparticles prepared by a similar process, but with a different antigen, have recently undergone detailed toxicological evaluation and appear to be safe for human use. 38,39 In a recent report, we have shown that combining a portion of the total dose of an antigen on alum and entrapping the remainder in microparticles gives a better initial antibody response with microparticles alone. 40 Hence, the current formulation for p200M may be improved by the addition of alum to the microparticles.…”

Section: Discussionmentioning

confidence: 97%

Biodegradable Microparticles with an Entrapped Branched Octameric Peptide as a Controlled-Release HIV-1 Vaccine

Singh

McGee

et al. 1997

Journal of Pharmaceutical Sciences

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Polyactide-co-glycolide microparticles, with an entrapped branched octameric peptide from human immunodeficiency virus (HIV-1), were prepared by a solvent evaporation method. The microparticles were characterized for size distribution, antigen loading level, and integrity. Mice in one group were each immunized with a single dose of a controlled-release microparticle formulation containing 300 micrograms of peptide and the serum IgG responses to the antigen were compared with those of mice from a second group that were immunized at 0, 4, and 26 weeks with 100-microgram doses of the same peptide immunogen adsorbed to alum. The controlled-release microparticles induced an antibody response comparable to that from the alum-immunized group. The subcutaneous and the intramuscular routes of administration were compared in additional groups of mice for the microparticles, and both routes induced similar responses. A suspending vehicle for the microparticles was also evaluated and did not affect the immunogenicity of the controlled-release formulation containing both small and large microparticles, although the immunogenicity of smaller microparticles immunized alone was affected.

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Poly (D,L-Lactide) glycolide polymer microsphere entrapped tetanus toxoid: safety evaluation in Wistar rats

Cited by 9 publications

References 8 publications

Immunogenicity and protection in small-animal models with controlled-release tetanus toxoid microparticles as a single-dose vaccine

Immunogenicity and protection in small-animal models with controlled-release tetanus toxoid microparticles as a single-dose vaccine

Poly-DL-lactide-co-glycolide microspheres as a controlled release antigen delivery system

Biodegradable Microparticles with an Entrapped Branched Octameric Peptide as a Controlled-Release HIV-1 Vaccine

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