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Published on: October 20, 2020
[Preparation, release and immunogenicity evaluation of HBsAg-PLGA microspheres]
Li Feng1, Xing-jun Zhou, Xian-rong Qi
1Department of Pharmaceutics, Peking University School of Pharmaceutical Sciences, Beijing 100083, China.
Objective:
To investigate microencapsulation technique, release of HBsAg-PLGA microspheres and degradation of the polymer in vitro, and the level of immune response after the single-dose HBsAg-PLGA microspheres subcutaneously injected (sc) to BALB/c mice.
Methods:
HBsAg-PLGA microspheres were prepared by double emulsion microencapsulation technique with orthogonal experiments. The pharmaceutical characteristics of size and surface morphology, antigen loading efficiency, release of HBsAg-PLGA microspheres and degradation of the polymer in vitro, and the level of immune response after single sc of PLGA microspheres in BALB/c mice were investigated.
Results:
The concentration of PVA was the significant factor affecting the particle size (P<0.05). The release of protein from the microspheres was controlled mainly by the bulk erosion of polymer matrix. When single sc of HBsAg-PLGA microspheres mixed with different formulations, the immunogenicity effect was comparable to that of the aluminium adjuvant vaccine.
Conclusion:
The single-dose HBsAg-PLGA microspheres mixture with different release behavior is a promising candidate for controlled delivery vaccine.
Insights
Single-dose HBsAg-PLGA microspheres show promise as a controlled delivery vaccine. These microspheres, when injected subcutaneously, elicit an immune response comparable to traditional aluminum adjuvant vaccines.
Area of Science:
- Biotechnology
- Materials Science
- Immunology
Background:
- Hepatitis B surface antigen (HBsAg) is crucial for developing effective vaccines.
- Poly(lactic-co-glycolic) acid (PLGA) microspheres offer a platform for controlled drug and antigen delivery.
- Investigating novel vaccine delivery systems is essential for improving immunogenicity and patient compliance.
Purpose of the Study:
- To optimize the microencapsulation of HBsAg within PLGA microspheres.
- To characterize the in vitro release kinetics and polymer degradation of HBsAg-PLGA microspheres.
- To evaluate the in vivo immunogenicity of a single-dose HBsAg-PLGA microsphere vaccine in mice.
Main Methods:
- HBsAg-PLGA microspheres were prepared using a double emulsion microencapsulation technique.
- Orthogonal experiments were employed to optimize formulation parameters.
- Pharmaceutical characteristics, in vitro release, polymer degradation, and subcutaneous immunogenicity in BALB/c mice were assessed.
Main Results:
- Polyvinyl alcohol (PVA) concentration significantly influenced particle size (P<0.05).
- Protein release from microspheres was primarily governed by bulk polymer erosion.
- Subcutaneous injection of HBsAg-PLGA microspheres demonstrated immunogenicity comparable to aluminum adjuvant vaccines.
Conclusions:
- The developed HBsAg-PLGA microspheres exhibit controlled release properties.
- A single dose of these microspheres shows potential as a vaccine candidate.
- This controlled delivery system holds promise for future vaccine development.

