Thermostable, Dissolvable Buccal Film Rotavirus Vaccine Is Highly Effective in Neonatal Gnotobiotic Pig Challenge Model

Hensley, Casey; Zhou, Peng; Schnur, Sofia; Mahsoub, Hassan M.; Yu, Liang; Wang, Min-Xuan; Page, Caroline; Yuan, Lijuan; Bronshtein, Victor

doi:10.3390/vaccines9050437

Cited by 8 publications

(2 citation statements)

References 36 publications

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“…It is possible that an attenuated vaccine and DNA vaccine can be delivered via a film dosage form. In a recent investigation, oral dissolvable buccal film was fabricated from HPC, triacetin and pH enhancing agent (calcium carbonate) to encapsulate and stabilize live attenuated thermostable tetravalent rhesus-human reassortant rotavirus vaccine [121]. Preserved film vaccine demonstrated strong protection against virus shedding and diarrhea after being tested with a large dose of a virulent G1 HRV in gnotobiotic pigs Fast dissolving buccal film dosage forms could be developed as therapeutic vaccines for local or systemic administration.…”

Section: Buccal Filmmentioning

confidence: 99%

An Updated Overview of the Emerging Role of Patch and Film-Based Buccal Delivery Systems

et al. 2021

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Buccal mucosal membrane offers an attractive drug-delivery route to enhance both systemic and local therapy. This review discusses the benefits and drawbacks of buccal drug delivery, anatomical and physiological aspects of oral mucosa, and various in vitro techniques frequently used for examining buccal drug-delivery systems. The role of mucoadhesive polymers, penetration enhancers, and enzyme inhibitors to circumvent the formulation challenges particularly due to salivary renovation cycle, masticatory effect, and limited absorption area are summarized. Biocompatible mucoadhesive films and patches are favored dosage forms for buccal administration because of flexibility, comfort, lightness, acceptability, capacity to withstand mechanical stress, and customized size. Preparation methods, scale-up process and manufacturing of buccal films are briefed. Ongoing and completed clinical trials of buccal film formulations designed for systemic delivery are tabulated. Polymeric or lipid nanocarriers incorporated in buccal film to resolve potential formulation and drug-delivery issues are reviewed. Vaccine-enabled buccal films have the potential ability to produce both antibodies mediated and cell mediated immunity. Advent of novel 3D printing technologies with built-in flexibility would allow multiple drug combinations as well as compartmentalization to separate incompatible drugs. Exploring new functional excipients with potential capacity for permeation enhancement of particularly large-molecular-weight hydrophilic drugs and unstable proteins, oligonucleotides are the need of the hour for rapid advancement in the exciting field of buccal drug delivery.

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Section: Buccal Filmmentioning

confidence: 99%

An Updated Overview of the Emerging Role of Patch and Film-Based Buccal Delivery Systems

et al. 2021

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“…Gn pigs were derived via surgical hysterectomy, housed in germ-free isolators, and fed ultra-high temperature sterilized whole cow’s milk as previously described [ 12 ]. Neonatal (5–7 day old) Gn pigs were orally inoculated with 5 × 10 7 FFU of the attenuated Wa strain of rotavirus (Wa AttHRV), Rotarix (the licensed, live, oral attenuated vaccine from GlaxoSmithKline) [ 13 ], or recombinant rhesus rotaviruses (rRRVs) (a component of the formerly available RotaShield vaccine from Wyeth Laboratories) [ 14 ] suspended in Diluent #5.…”

Section: Methodsmentioning

confidence: 99%

Human Rotavirus Replicates in Salivary Glands and Primes Immune Responses in Facial and Intestinal Lymphoid Tissues of Gnotobiotic Pigs

Nyblade,

Zhou,

Frazier

et al. 2023

Viruses

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Human rotavirus (HRV) is a leading cause of viral gastroenteritis in children across the globe. The virus has long been established as a pathogen of the gastrointestinal tract, targeting small intestine epithelial cells and leading to diarrhea, nausea, and vomiting. Recently, this classical infection pathway was challenged by the findings that murine strains of rotavirus can infect the salivary glands of pups and dams and transmit via saliva from pups to dams during suckling. Here, we aimed to determine if HRV was also capable of infecting salivary glands and spreading in saliva using a gnotobiotic (Gn) pig model of HRV infection and disease. Gn pigs were orally inoculated with various strains of HRV, and virus shedding was monitored for several days post-inoculation. HRV was shed nasally and in feces in all inoculated pigs. Infectious HRV was detected in the saliva of four piglets. Structural and non-structural HRV proteins, as well as the HRV genome, were detected in the intestinal and facial tissues of inoculated pigs. The pigs developed high IgM antibody responses in serum and small intestinal contents at 10 days post-inoculation. Additionally, inoculated pigs had HRV-specific IgM antibody-secreting cells present in the ileum, tonsils, and facial lymphoid tissues. Taken together, these findings indicate that HRV can replicate in salivary tissues and prime immune responses in both intestinal and facial lymphoid tissues of Gn pigs.

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Vaccine process technology—A decade of progress

Buckland,

Sanyal,

Ranheim

et al. 2024

Biotech & Bioengineering

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In the past decade, new approaches to the discovery and development of vaccines have transformed the field. Advances during the COVID‐19 pandemic allowed the production of billions of vaccine doses per year using novel platforms such as messenger RNA and viral vectors. Improvements in the analytical toolbox, equipment, and bioprocess technology have made it possible to achieve both unprecedented speed in vaccine development and scale of vaccine manufacturing. Macromolecular structure‐function characterization technologies, combined with improved modeling and data analysis, enable quantitative evaluation of vaccine formulations at single‐particle resolution and guided design of vaccine drug substances and drug products. These advances play a major role in precise assessment of critical quality attributes of vaccines delivered by newer platforms. Innovations in label‐free and immunoassay technologies aid in the characterization of antigenic sites and the development of robust in vitro potency assays. These methods, along with molecular techniques such as next‐generation sequencing, will accelerate characterization and release of vaccines delivered by all platforms. Process analytical technologies for real‐time monitoring and optimization of process steps enable the implementation of quality‐by‐design principles and faster release of vaccine products. In the next decade, the field of vaccine discovery and development will continue to advance, bringing together new technologies, methods, and platforms to improve human health.

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Thermostable, Dissolvable Buccal Film Rotavirus Vaccine Is Highly Effective in Neonatal Gnotobiotic Pig Challenge Model

Cited by 8 publications

References 36 publications

An Updated Overview of the Emerging Role of Patch and Film-Based Buccal Delivery Systems

An Updated Overview of the Emerging Role of Patch and Film-Based Buccal Delivery Systems

Human Rotavirus Replicates in Salivary Glands and Primes Immune Responses in Facial and Intestinal Lymphoid Tissues of Gnotobiotic Pigs

Vaccine process technology—A decade of progress

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