ArticlePharmaceutical research2019
Design and Optimization of a Temperature-Stable Dry Powder BCG Vaccine.
Article in Pharmaceutical research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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The trial behind it
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Who cites it
12 citing papers in PubMed.
- Formulation, Characterization, and In Vivo Immunogenicity of Heat-Stabilized Dissolvable Microneedles Containing a Novel VLP Vaccine.Pharmaceutical research · 2025Article
- Understanding dry proteins and their protection with solid-state hydrogen-deuterium exchange.Protein science : a publication of the Protein Society · 2025Review
- Respiratory delivered vaccines: Current status and perspectives in rational formulation design.Acta pharmaceutica Sinica. B · 2024Review
- Chitosan-Based Dressing as a Sustained Delivery System for Bioactive Cytokines.International journal of molecular sciences · 2023Article
- Repurposing mucosal delivery devices for live attenuated tuberculosis vaccines.Frontiers in immunology · 2023Article
- Article
- Evaluation of the stability of a spray-dried tuberculosis vaccine candidate designed for dry powder respiratory delivery.Vaccine · 2021Article
- COVID-19 pandemic: SARS-CoV-2 specific vaccines and challenges, protection via BCG trained immunity, and clinical trials.Expert review of vaccines · 2021Review
- Microparticle encapsulation of a tuberculosis subunit vaccine candidate containing a nanoemulsion adjuvant via spray drying.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2021Article
- Development of a formulation platform for a spray-dried, inhalable tuberculosis vaccine candidate.International journal of pharmaceutics · 2021Article
- Development and Testing of a Spray-Dried Tuberculosis Vaccine Candidate in a Mouse Model.Frontiers in pharmacology · 2021Article
- Emerging trends in inhaled drug delivery.Advanced drug delivery reviews · 2020Review
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
purposeLoss of vaccine potency due to extreme temperature exposure during storage and transport remains a significant obstacle to the success of many vaccines, including the Bacille Calmette-Guérin (BCG) vaccine, the only vaccine available against Mycobacterium tuberculosis. BCG is a live, attenuated vaccine requiring refrigerated storage for viability. In this study, we formulated a temperature-stable BCG dry powder using the spray drying technique.
methodsWe employed a factorial design to optimize our formulation of stabilizing excipients that included L-leucine, bovine serum albumin, polyvinylpyrrolidone, mannitol, and trehalose. Powders were characterized for their particle size, yield, water retention and uptake, glass transition temperature, and aerosol performance. Three optimal powder carrier mixtures were selected from the factorial design for BCG incorporation based on their stability-promoting and powder flow characteristics. Vaccine powders were also assessed for BCG viability and in vivo immunogenicity after long-term storage.
resultsLive BCG was successfully spray-dried using the optimized carriers. Dry powder BCG showed no loss in viability (25°C, up to 60% relative humidity; RH) and ~2-log loss in viability (40°C, 75% RH) after one year of storage. The aerodynamic size of the powders was in the respirable range. Further, when healthy mice were immunized intradermally with reconstituted BCG powders (storage for 2 years), the vaccine retained its immunogenicity.
conclusionWe developed a spray-dried BCG vaccine that was viable and antigenic after long-term storage. To our knowledge, this is a first study to show room temperature stability of live BCG vaccine without any loss in viability for 12 months.
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Registered trials
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