Potential of polymeric particles as future vaccine delivery systems/adjuvants for parenteral and non-parenteral immunization against tuberculosis: A systematic review

Document Type: Review Article

Authors

1 Department of Microbiology, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran

2 Antimicrobial Resistance Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

3 Department of Medical Bacteriology and Virology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

4 Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran

Abstract

Objective(s): Production of effective tuberculosis (TB) vaccine is necessity. However, the development of new subunit vaccines is faced with concerns about their weak immunogenicity. To overcome such problems, polymers-based vaccine delivery systems have been proposed to be used via various routes. The purpose of this study was to determine the potential of polymeric particles as future vaccine delivery systems/adjuvants for parenteral and non-parenteral immunization against TB.
Materials and Methods: PubMed, Scopus, Science-Direct, and the ISI web of knowledge databases were searched for related keywords. A total of 420 articles, written up to June 25, 2016, were collected on the potential of polymeric particles as TB vaccine delivery systems after parenteral and non-parenteral immunization. Thirty-one relevant articles were selected by applying inclusion and exclusion criteria.
Results: It was shown that the immunogenicity of TB vaccines had been improved by using biodegradable and non-biodegradable synthetic polymers as well as natural polymers and they are better able to enhance the humoral and cellular immune responses, compared to TB vaccines alone. The present study revealed that various polymeric particles, after M. tuberculosis challenge in animal models, provide long-lasting protection against TB. PLGA (poly (lactide-co-glycolide)) and chitosan polymers were widely used as TB vaccine delivery systems/adjuvants.
Conclusion: It seems that PLGA and chitosan polymers are well-suited particles for the parenteral and non-parenteral administration of TB vaccines, respectively. Non-biodegradable synthetic polymers in comparison with biodegradable synthetic and natural polymers have been used less frequently. Therefore, further study on this category of polymers is required.

Keywords

Main Subjects


1.Khademi F, Yousefi-Avarvand A, Derakhshan M, Meshkat Z, Tafaghodi M, Ghazvini K, et al. Mycobacterium tuberculosis HspX/EsxS Fusion Protein: Gene Cloning, Protein Expression, and Purification in Escherichia coli. Reports of Biochemistry and Molecular Biology 2017; 6:15-21.

2.Khademi F, Yousefi-Avarvand A, Derakhshan M, Vaez H, Sadeghi R. Middle East Mycobacterium tuberculosis Antibiotic Resistance: A Systematic Review and Meta-Analysis. Infection, Epidemiology and Medicine. 2017; 3:25-35.

3.Karimi SM, Sankian M, Khademi F, Tafaghodi M. Chitosan (CHT) and trimethylchitosan (TMC) nanoparticles as adjuvant/delivery system for parenteral and nasal immunization against Mycobacterium tuberculosis (MTb) ESAT-6 antigen. Nanomed J 2016; 3:223-229.

4.Khademi F, Derakhshan M, Sadeghi R. The role of Toll-Like Receptor Gene Polymorphisms in Tuberculosis Susceptibility: A Systematic Review and Meta-Analysis. Rev Clin Med 2016; 3:133-140.

5.Da Costa C, Walker B, Bonavia A. Tuberculosis Vaccines–state of the art, and novel approaches to vaccine development. Int J Infect Dis 2015; 32:5-12.

6.Islam MA, Firdous J, Choi Y-J, Yun C-H, Cho C-S. Design and application of chitosan microspheres as oral and nasal vaccine carriers: an updated review. Int J Nanomedicine 2012; 7:6077-6093.

7.Reddy ST, Swartz MA, Hubbell JA. Targeting dendritic cells with biomaterials: developing the next generation of vaccines. Trends Immunol 2006; 27:573-579.

8.Garg NK, Dwivedi P, Jain A, Tyagi S, Sahu T, Tyagi RK. Development of novel carrier (s) mediated tuberculosis vaccine: More than a tour de force. Eur J Pharm Sci 2014; 62:227-242.

9.Tafaghodi M, Sajadi Tabassi S, Jaafari MR. Nasal Immunization by (PLGA) Nanospheres Encapsulated with Tetanus Toxoid and (CpG-ODN) IJPR. 2010:151-158.

10.Tafaghodi M, Khamesipour A, Jaafari MR. Immunization against leishmaniasis by PLGA nanospheres encapsulated with autoclaved Leishmania major (ALM) and CpG-ODN. Parasitol Res 2011; 108:1265-1273.

11.Mohaghegh M, Tafaghodi M. Dextran microspheres could enhance immune responses against PLGA nanospheres encapsulated with tetanus toxoid and Quillaja saponins after nasal immunization in rabbit. ‎Pharm Dev Technol 2011; 16:36-43.

12.Muhamad12 II, Selvakumaran S, Lazim NAM. Designing Polymeric Nanoparticles for Targeted Drug Delivery System. Nanomed 2014; 287-312.

13.Tafaghodi M, Rastegar S. Preparation and in vivo study of dry powder microspheres for nasal immunization. J Drug Target 2010; 18:235-242.

14.Wang S, Liu H, Zhang X, Qian F. Intranasal and oral vaccination with protein-based antigens: advantages, challenges and formulation strategies. Protein & cell 2015:1-24.

15.Renegar KB, Small PA, Boykins LG, Wright PF. Role of IgA versus IgG in the control of influenza viral infection in the murine respiratory tract. J Immunol 2004; 173:1978-1986.

16.Yuk J-M, Jo E-K. Host immune responses to mycobacterial antigens and their implications for the development of a vaccine to control tuberculosis. Clin Exp Vaccine Res 2014; 3:155-167.

17.Abebe F, Bjune G. The protective role of antibody responses during Mycobacterium tuberculosis infection. Clin Exp Immunol 2009; 157:235-243.

18.Khader SA, Gaffen SL, Kolls JK. Th17 cells at the crossroads of innate and adaptive immunity against infectious diseases at the mucosa. Mucosal Immunol 2009; 2:403-411.

19.De Valliere S, Abate G, Blazevic A, Heuertz R, Hoft D. Enhancement of innate and cell-mediated immunity by antimycobacterial antibodies. Infect Immun 2005; 73:6711-6720.

20.Tafaghodi M, Tabassi SAS, Jaafari M-R, Zakavi SR, Momennejad M. Evaluation of the clearance characteristics of various microspheres in the human nose by gamma-scintigraphy. Int J Pharm 2004; 280:125-135.

21.Rose F, Wern JE, Ingvarsson PT, van de Weert M, Andersen P, Follmann F, et al. Engineering of a novel adjuvant based on lipid-polymer hybrid nanoparticles: A quality-by-design approach. ‎J Control Rel 2015; 210:48-57.

22.Carlétti D, da Fonseca DM, Gembre AF, Masson AP, Campos LW, Leite LC, et al. A Single Dose of a DNA Vaccine Encoding Apa Coencapsulated with 6, 6′-Trehalose Dimycolate in Microspheres Confers Long-Term Protection against Tuberculosis in Mycobacterium bovis BCG-Primed Mice. Clin Vaccine Immunol 2013; 20:1162-1169.

23.Shi S, Hickey AJ. PLGA microparticles in respirable sizes enhance an in vitro T cell response to recombinant Mycobacterium tuberculosis antigen TB10. 4-Ag85B. Pharmaceut Res 2010; 27:350-360.

24.Bivas-Benita M, Lin MY, Bal SM, van Meijgaarden KE, Franken KL, Friggen AH, et al. Pulmonary delivery of DNA encoding Mycobacterium tuberculosis latency antigen Rv1733c associated to PLGA–PEI nanoparticles enhances T cell responses in a DNA prime/protein boost vaccination regimen in mice. Vaccine 2009; 27:4010-4017.

25.Kirby DJ, Rosenkrands I, Agger EM, Andersen P, Coombes AG, Perrie Y. PLGA microspheres for the delivery of a novel subunit TB vaccine. ‎J Drug Target 2008; 16:282-293.

26.de Paula L, Silva CL, Carlos D, Matias-Peres C, Sorgi CA, Soares EG, et al. Comparison of different delivery systems of DNA vaccination for the induction of protection against tuberculosis in mice and guinea pigs. Genet Vaccines Ther 2007; 5:1-7.

27.Lu D, Garcia-Contreras L, Xu D, Kurtz SL, Liu J, Braunstein M, et al. Poly (lactide-co-glycolide) microspheres in respirable sizes enhance an in vitro T cell response to recombinant Mycobacterium tuberculosis antigen 85B. Pharmaceut Res 2007; 24:1834-1843.

28.Ha S-J, Park S-H, Kim H-J, Kim S-C, Kang H-J, Lee E-G, et al. Enhanced immunogenicity and protective efficacy with the use of interleukin-12-encapsulated microspheres plus AS01B in tuberculosis subunit vaccination. Infect Immun 2006; 74:4954-4959.

29.Cai H, Hu X, Yu D, Li S, Tian X, Zhu Y. Combined DNA vaccine encapsulated in microspheres enhanced protection efficacy against Mycobacterium tuberculosis infection of mice. Vaccine 2005; 23:4167-4174.

30.Evans JT, Ward JR, Kern J, Johnson ME. A single vaccination with protein-microspheres elicits a strong CD8 T-cell-mediated immune response against Mycobacterium tuberculosis antigen Mtb8. 4. Vaccine 2004; 22:1964-1972.

31.Lima K, Santos S, Lima V, Coelho-Castelo A, Rodrigues J, Silva C. Single dose of a vaccine based on DNA encoding mycobacterial hsp65 protein plus TDM-loaded PLGA microspheres protects mice against a virulent strain of Mycobacterium tuberculosis. Gene Ther 2003; 10:678-685.

32.Lima VM, Bonato VL, Lima KM, Dos Santos SA, Dos Santos RR, Gonçalves ED, et al. Role of trehalose dimycolate in recruitment of cells and modulation of production of cytokines and NO in tuberculosis. Infect Immun 2001; 69:5305-5312.

33.Dhiman N, Khuller G. Protective efficacy of mycobacterial 71-kDa cell wall associated protein using poly (DL-lactide-co-glycolide) microparticles as carrier vehicles. FEMS Immunol Med Microbiol 1998; 21:19-28.

34.Carpenter ZK, Williamson ED, Eyles JE. Mucosal delivery of microparticle encapsulated ESAT-6 induces robust cell-mediated responses in the lung milieu. ‎J Control Rel 2005; 104:67-77.

35.Venkataprasad N, Coombes A, Singh M, Rohde M, Wilkinson K, Hudecz F, et al. Induction of cellular immunity to a mycobacterial antigen adsorbed on lamellar particles of lactide polymers. Vaccine 1999; 17:1814-1819.

36.Todoroff J, Ucakar B, Inglese M, Vandermarliere S, Fillee C, Renauld J-C, et al. Targeting the deep lungs, Poloxamer 407 and a CpG oligonucleotide optimize immune responses to Mycobacterium tuberculosis antigen 85A following pulmonary delivery. Eur J Pharm Biopharm 2013; 84:40-48.

37.Orr MT, Kramer RM, Barnes L, Dowling QM, Desbien AL, Beebe EA, et al. Elimination of the cold-chain dependence of a Nano emulsion adjuvanted vaccine against tuberculosis by lyophilization. J Control Rel 2014; 177:20-26.

38.Yeboah KG, D'souza MJ. Evaluation of albumin microspheres as oral delivery system for Mycobacterium tuberculosis vaccines. ‎J Microencaps 2009; 26:166-179.

39.Meerak J, Wanichwecharungruang SP, Palaga T. Enhancement of immune response to a DNA vaccine against Mycobacterium tuberculosis Ag85B by incorporation of an autophagy inducing system. Vaccine 2013; 31:784-790.

40.Feng G, Jiang Q, Xia M, Lu Y, Qiu W, Zhao D, et al. Enhanced immune response and protective effects of nano-chitosan-based DNA vaccine encoding T cell epitopes of Esat-6 and FL against Mycobacterium tuberculosis infection. PLoS One 2013; 8:1-10.

41.Ai W, Yue Y, Xiong S, Xu W. Enhanced protection against pulmonary mycobacterial challenge by chitosan‐formulated polyepitope gene vaccine is associated with increased pulmonary secretory IgA and gamma‐interferon+ T cell responses. Microbiol Immunol 2013; 57:224-235.

42.Verma A, Pandey R, Chanchal A, Siddiqui I, Sharma P. Encapsulation of Antigenic Secretory Proteins of Mycobacterium tuberculosis in Biopolymeric Nanoparticles for Possible Aerosol Delivery System. Journal of Bionanoscience 2011; 5:88-95.

43.Caetano LA, Figueiredo L, Almeida AJ, Gonçalves L, editors. Alginate-chitosan particulate delivery systems for mucosal immunization against tuberculosis. Bioengineering (ENBENG), 2012 IEEE 2nd Portuguese Meeting in; 2012: IEEE.

44.dong Zhu B, qing Qie Y, ling Wang J, Zhang Y, zhong Wang Q, Xu Y, et al. Chitosan microspheres enhance the immunogenicity of an Ag85B-based fusion protein containing multiple T-cell epitopes of Mycobacterium tuberculosis. Eur J Pharm Biopharm 2007; 66:318-326.

45.Bivas-Benita M, van Meijgaarden KE, Franken KL, Junginger HE, Borchard G, Ottenhoff TH, et al. Pulmonary delivery of chitosan-DNA nanoparticles enhances the immunogenicity of a DNA vaccine encoding HLA-A* 0201-restricted T-cell epitopes of Mycobacterium tuberculosis. Vaccine 2004; 22:1609-1615.

46.Dobakhti F, Naghibi T, Taghikhani M, Ajdary S, Rafinejad A, Bayati K, et al. Adjuvanticity effect of sodium alginate on subcutaneously injected BCG in BALB/c mice. Microb Infect 2009; 11:296-301.

47.Ajdary S, Dobakhti F, Taghikhani M, Riazi-Rad F, Rafiei S, Rafiee-Tehrani M. Oral administration of BCG encapsulated in alginate microspheres induces strong Th1 response in BALB/c mice. Vaccine 2007; 25:4595-4601.

48.Dobakhti F, Ajdary S, Taghikhani M, Rafiei S, Bayati K, Rafiee-Tehrani M. Immune response following oral immunization with BCG encapsulated in alginate microspheres. Iran J Immunol 2006; 3:114-120.

49.Wilkinson KA, Belisle JT, Mincek M, Wilkinson RJ, Toossi Z. Enhancement of the human T cell response to culture filtrate fractions of Mycobacterium tuberculosis by microspheres. J Immunol Methods 2000; 235:1-9.

50.Yu F, Wang J, Dou J, Yang H, He X, Xu W et al. Nanoparticle-based adjuvant for enhanced protective efficacy of DNA vaccine Ag85A-ESAT-6-IL-21 against Mycobacterium tuberculosis infection. Nanomedicine: Nanotechnology, Biology and Medicine 2012; 8:1337-1344.

51.Ballester M, Nembrini C, Dhar N, De Titta A, De Piano C, Pasquier M, et al. Nanoparticle conjugation and pulmonary delivery enhance the protective efficacy of Ag85B and CpG against tuberculosis Vaccine. 2011; 29:6959-6966.

52.Andersen P. Vaccine strategies against latent tuberculosis infection. Trends Microbiol 2007; 15:7-13.

53.Principi N, Esposito S. The present and future of tuberculosis vaccinations. Tuberculosis 2015; 95:6-13.

54.Wedlock D, Keen D, McCarthy A, Andersen P, Buddle B. Effect of different adjuvants on the immune responses of cattle vaccinated with Mycobacterium tuberculosis culture filtrate proteins. Vet Immunol Immunopathol 2002; 86:79-88.

55.Jensen DK, Jensen LB, Koocheki S, Bengtson L, Cun D, Nielsen HM, et al. Design of an inhalable dry powder formulation of DOTAP-modified PLGA nanoparticles loaded with siRNA. ‎J Control Rel 2012; 157:141-148.

56.McHugh KJ, Guarecuco R, Langer R, Jaklenec A. Single-injection vaccines: Progress, challenges, and opportunities. J Control Release 2015; 219:596-609.