title: Evaluation of synergistic effect of biodegradable polymeric nanoparticles and aluminum based adjuvant for improving vaccine efficacy.
abstract: Aluminum based adjuvants have been used widely to induce long lasting protective immunity through vaccination. But reported incidences of toxicity and side effects of aluminum have raised concerns regarding their safety in childhood vaccines. The present study demonstrates the synergistic effect of admixture of polylactic acid-polyethylene glycol (PLA-PEG) based biodegradable nanoparticles (NPs) and aluminum phosphate as a potential adjuvant system using tetanus toxoid (TT) as a model antigen. The immunological activity of the admixture formulation was maintained up to 180 days of storage at 5 °C±3 °C. Percent adsorption/encapsulation of tetanus toxoid increased to nearly 90% in admixture formulation as compared to 55% in conventional vaccine. Admixture preparation (PLA-PEG-Al 0.2 mg-TT and PLA-Al 0.2 mg-TT) showed 80% and 50% survival respectively, even at 180 days as compared to 30% survival observed in the conventional tetanus vaccine. The present study established the feasibility to formulate a dosage form with improved efficacy and reduced aluminum concentration for vaccination.
authors.affiliation: Centre for Biomedical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi 110016, India; Central Research Institute, Kasauli, India. Electronic address: vivekb1979@gmail.com.
authors.forename: Vivek
authors.initials: V
authors.lastname: Bansal
authors.affiliation: Centre for Biomedical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi 110016, India. Electronic address: manojgautam.iitd@gmail.com.
authors.forename: Manoj
authors.initials: M
authors.lastname: Kumar
authors.affiliation: Centre for Biomedical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi 110016, India. Electronic address: nakul1432@gmail.com.
authors.forename: Manu
authors.initials: M
authors.lastname: Dalela
authors.affiliation: Central Research Institute, Kasauli, India; BCG Vaccine Laboratory, Guindy, Chennai, India. Electronic address: drbhemant@yahoo.com.
authors.forename: H G
authors.initials: HG
authors.lastname: Brahmne
authors.affiliation: Centre for Biomedical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi 110016, India. Electronic address: harpal2000@yahoo.com.
authors.forename: Harpal
authors.initials: H
authors.lastname: Singh
mesh_terms: D000277:Adjuvants, Pharmaceutic / Q000737:chemistry*; D017607:Aluminum Compounds / Q000737:chemistry*; D000818:Animals; D000906:Antibodies / Q000097:blood; D001672:Biocompatible Materials / Q000737:chemistry*; D004337:Drug Carriers / Q000737:chemistry*; D004339:Drug Compounding; D004357:Drug Synergism; D007773:Lactates / Q000737:chemistry*; D008099:Liver / Q000187:drug effects / Q000473:pathology; D051379:Mice; D053758:Nanoparticles / Q000737:chemistry*; D010316:Particle Size; D010710:Phosphates / Q000737:chemistry*; D011092:Polyethylene Glycols / Q000737:chemistry*; D013499:Surface Properties; D013745:Tetanus Toxoid / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
chemical_list: D000277:Adjuvants, Pharmaceutic; D017607:Aluminum Compounds; D000906:Antibodies; D001672:Biocompatible Materials; D004337:Drug Carriers; D007773:Lactates; D010710:Phosphates; D013745:Tetanus Toxoid; C088513:poly(lactic acid-ethylene glycol); D011092:Polyethylene Glycols; C012714:aluminum phosphate
keywords: Adjuvants; Aluminum phosphate; Nanoparticles; PLA; Tetanus; Vaccine