Development of a dried influenza whole inactivated virus vaccine for pulmonary immunization

Audouy, Sandrine; Schaaf, Gerda van der; Hinrichs, Wouter L. J.; Frijlink, Henderik W.; Wilschut, Jan; Huckriede, Anke

doi:10.1016/j.vaccine.2011.04.029

Cited by 73 publications

(83 citation statements)

References 39 publications

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“…One of the most successful technologies in this respect is PulmoSphere ™ (Novartis, developed by Nektar Therapeutics) [95]. Particle engineering is also needed to achieve stabilization of large molecules (biopharmaceuticals) in the dry state with sugar glasses (cryoprotectants) [97][98][99][100][101], prolonged drug release or therapeutic effect (e.g. by mucoadhesion) [102][103][104][105][106][107], and enhanced drug absorption [106,108].…”

Section: Formulation Of High-dose Drugsmentioning

confidence: 99%

“…The formulation has to contain the drug particles in the desired aerodynamic size distribution for deposition in the target area. Formulation design may be needed to achieve previously mentioned effects [97][98][99][100][101][102][103][104][105][106][107][108][109][110][111][112][113][114][115][116] or a better product stability. DPI devices need to disperse the formulation effectively into this size distribution, preferably at the lowest possible flow rate within the first 0.5 L (children) or 1 L (adults) of inhaled air to achieve drug distribution over the entire lung.…”

Section: Dpi Design and Pulmonary Drug Deposition And Distributionmentioning

confidence: 99%

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Dry powder inhalation: past, present and future

Boer

Hagedoorn

Hoppentocht

et al. 2016

Expert Opinion on Drug Delivery

226

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Introduction: Early dry powder inhalers (DPIs) were designed for low drug doses in asthma and COPD therapy. Nearly all concepts contained carrier-based formulations and lacked efficient dispersion principles. Therefore, particle engineering and powder processing are increasingly applied to achieve acceptable lung deposition with these poorly designed inhalers. Areas covered: The consequences of the choices made for early DPI development with respect of efficacy, production costs and safety and the tremendous amount of energy put into understanding and controlling the dispersion performance of adhesive mixtures are discussed. Also newly developed particle manufacturing and powder formulation processes are presented as well as the challenges, objectives, and new tools available for future DPI design. Expert opinion: Improved inhaler design is desired to make DPIs for future applications cost-effective and safe. With an increasing interest in high dose drug delivery, vaccination and systemic delivery via the lungs, innovative formulation technologies alone may not be sufficient. Safety is served by increasing patient adherence to the therapy, minimizing the use of unnecessary excipients and designing simple and self-intuitive inhalers, which give good feedback to the patient about the inhalation maneuver. For some applications, like vaccination and delivery of hygroscopic formulations, disposable inhalers may be preferred. ARTICLE HISTORY

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Section: Formulation Of High-dose Drugsmentioning

confidence: 99%

Section: Dpi Design and Pulmonary Drug Deposition And Distributionmentioning

confidence: 99%

Dry powder inhalation: past, present and future

Boer

Hagedoorn

Hoppentocht

et al. 2016

Expert Opinion on Drug Delivery

226

View full text Add to dashboard Cite

show abstract

“…Whole inactivated influenza virus (WIV) was derived from NIBRG-14 and NIBRG-23 viruses by inactivating them with β-propiolactone as described previously (21). Thereafter, WIV was purified by dialyzing overnight against HBS (2 mM Hepes, 125 mM NaCl, 0.9 mM CaCl 2 , and 0.5 mM MgCl 2 ; pH 7.4).…”

Section: Vaccinementioning

confidence: 99%

“…Influenza vaccines can be stabilized by incorporating them into a glassy matrix of a sugar, e.g., inulin, dextran, or trehalose, for example, by means of freeze-drying techniques (19)(20)(21)(22). Dried vaccines can be reconstituted prior to intramuscular (i.m.)…”

Section: Introductionmentioning

confidence: 99%

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Simplifying Influenza Vaccination During Pandemics: Sublingual Priming and Intramuscular Boosting of Immune Responses with Heterologous Whole Inactivated Influenza Vaccine

Murugappan

Patil

Frijlink

et al. 2014

AAPS J

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Characterization of humoral immune responses and degree of protection induced by influenza vaccine in cotton rats: Effects of low vaccine dose and single vs booster vaccination

Bhide

Dong

Meijerhof

et al. 2020

Immunity Inflam & Disease

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Introduction: Cotton rats are a suitable model for the study of influenza disease symptoms and responses to influenza vaccination. We have previously shown that two immunizations with 15 µg whole inactivated virus (WIV) influenza vaccine could completely protect animals from infection with the H1N1pdm09 virus. Methods: To further explore the cotton rat model, we here investigated the protective potential of a single intramuscular immunization and of prime/ boost intramuscular immunizations with a low amount of antigen. Results: A single intramuscular immunization with doses more than or equal to 0.5 µg WIV reliably evoked antibody responses and doses more than or equal to 1 µg protected the animals from virus replication in the lungs and from severe weight loss. However, clinical symptoms like an increased respiration rate were still apparent. Administration of a booster dose significantly increased the humoral immune responses but did not or only moderately improved protection from clinical symptoms. Conclusion: Our data suggest that complete and partial protection by influenza vaccines can be mimicked in cotton rats by using specific vaccination regimens.

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Development of a dried influenza whole inactivated virus vaccine for pulmonary immunization

Cited by 73 publications

References 39 publications

Dry powder inhalation: past, present and future

Dry powder inhalation: past, present and future

Simplifying Influenza Vaccination During Pandemics: Sublingual Priming and Intramuscular Boosting of Immune Responses with Heterologous Whole Inactivated Influenza Vaccine

Characterization of humoral immune responses and degree of protection induced by influenza vaccine in cotton rats: Effects of low vaccine dose and single vs booster vaccination

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