Buccal Administration of a Zika Virus Vaccine Utilizing 3D-Printed Oral Dissolving Films in a Mouse Model.

Over the years, research regarding the Zika virus has been steadily increasing. Early immunization for ZIKV is a priority for preventing complications such as microencephaly and Guillain-Barré syndrome (GBS). Unlike traditional vaccination approaches, oral dissolving films (ODFs) or mucoadhesive film technology is an emerging, exciting concept that can be used in the field of pharmaceuticals for vaccine design and formulation development. This attractive and novel method can help patients who suffer from dysphagia as a complication of a disease or syndrome. In this study, we investigated a microparticulate Zika vaccine administered via the buccal route with the help of thin films or oral dissolving films (ODFs) with a prime dose and two booster doses two weeks apart. In vitro, the ODFs displayed excellent physiochemical properties, indicating that the films were good carriers for vaccine microparticles and biocompatible with the buccal mucosa. In vivo results revealed robust humoral (IgG, subtypes IgG1 and IgG2a) and T-cell responses (CD4+/CD8+) for ZIKV-specific immunity. Both the Zika MP vaccine and the adjuvanted Zika MP vaccine affected memory (CD45R/CD27) and intracellular cytokine (TNF-α and IL-6) expression. In this study, ZIKV vaccination via the buccal route with the aid of ODFs demonstrated great promise for the development of pain-free vaccines for infectious diseases.

Intranasal Immunization for Zika in a Pre-Clinical Model.

Humans continue to be at risk from the Zika virus. Although there have been significant research advancements regarding Zika, the absence of a vaccine or approved treatment poses further challenges for healthcare providers. In this study, we developed a microparticulate Zika vaccine using an inactivated whole Zika virus as the antigen that can be administered pain-free via intranasal (IN) immunization. These microparticles (MP) were formulated using a double emulsion method developed by our lab. We explored a prime dose and two-booster-dose vaccination strategy using MPL-A® and Alhydrogel® as adjuvants to further stimulate the immune response. MPL-A® induces a Th1-mediated immune response and Alhydrogel® (alum) induces a Th2-mediated immune response. There was a high recovery yield of MPs, less than 5 µm in size, and particle charge of -19.42 ± 0.66 mV. IN immunization of Zika MP vaccine and the adjuvanted Zika MP vaccine showed a robust humoral response as indicated by several antibodies (IgA, IgM, and IgG) and several IgG subtypes (IgG1, IgG2a, and IgG3). Vaccine MP elicited a balance Th1- and Th2-mediated immune response. Immune organs, such as the spleen and lymph nodes, exhibited a significant increase in CD4+ helper and CD8+ cytotoxic T-cell cellular response in both vaccine groups. Zika MP vaccine and adjuvanted Zika MP vaccine displayed a robust memory response (CD27 and CD45R) in the spleen and lymph nodes. Adjuvanted vaccine-induced higher Zika-specific intracellular cytokines than the unadjuvanted vaccine. Our results suggest that more than one dose or multiple doses may be necessary to achieve necessary immunological responses. Compared to unvaccinated mice, the Zika vaccine MP and adjuvanted MP vaccine when administered via intranasal route demonstrated robust humoral, cellular, and memory responses. In this pre-clinical study, we established a pain-free microparticulate Zika vaccine that produced a significant immune response when administered intranasally.

Development and usability of an EHR-driven hypertension disparities dashboard in primary care: A qualitative study.

Hypertension disparities persist and remain high among racial and ethnic minority populations in the United States (US). Data-driven approaches based on electronic health records (EHRs) in primary care are seen as a strong opportunity to address this situation. This qualitative study evaluated the development, sustainability, and usability of an EHR-integrated hypertension disparities dashboard for health care professionals in primary care. Ten semi-structured interviews, exploring the approach and sustainability, as well as eight usability interviews, using the think aloud protocol were conducted with quality improvement managers, data analysts, program managers, evaluators, and primary care providers. For the results, dashboard development steps include having clear goals, defining a target audience, compiling data, and building multidisciplinary teams. For sustainability, the dashboard can enhance understanding of the social determinants of health or to inform QI projects. In terms of dashboard usability, positive aspects consisted of the inclusion of summary pages, patient's detail pages, and hover-over interface. Important design considerations were refining sorting functions, gender inclusivity, and increasing dashboard visibility. In sum, an EHR-driven dashboard can be a novel tool for addressing hypertension disparities in primary care. It offers a platform where clinicians can identify patients for culturally tailored interventions. Factors such as physician time constraints, data definitions, comprehensive patient demographic information, end-users, and future sustenance, should be considered before implementing a dashboard. Additional research is needed to identify practices for integrating a dashboard into clinical workflow for hypertension.

Electronic Health Record-Driven Approaches in Primary Care to Strengthen Hypertension Management Among Racial and Ethnic Minoritized Groups in the United States: Systematic Review.

BACKGROUND: Managing hypertension in racial and ethnic minoritized groups (eg, African American/Black patients) in primary care is highly relevant. However, evidence on whether or how electronic health record (EHR)-driven approaches in primary care can help improve hypertension management for patients of racial and ethnic minoritized groups in the United States remains scarce. OBJECTIVE: This review aims to examine the role of the EHR in supporting interventions in primary care to strengthen the hypertension management of racial and ethnic minoritized groups in the United States. METHODS: A search strategy based on the PICO (Population, Intervention, Comparison, and Outcome) guidelines was utilized to query and identify peer-reviewed articles on the Web of Science and PubMed databases. The search strategy was based on terms related to racial and ethnic minoritized groups, hypertension, primary care, and EHR-driven interventions. Articles were excluded if the focus was not hypertension management in racial and ethnic minoritized groups or if there was no mention of health record data utilization. RESULTS: A total of 29 articles were included in this review. Regarding populations, Black/African American patients represented the largest population (26/29, 90%) followed by Hispanic/Latino (18/29, 62%), Asian American (7/29, 24%), and American Indian/Alaskan Native (2/29, 7%) patients. No study included patients who identified as Native Hawaiian/Pacific Islander. The EHR was used to identify patients (25/29, 86%), drive the intervention (21/29, 72%), and monitor results and outcomes (7/29, 59%). Most often, EHR-driven approaches were used for health coaching interventions, disease management programs, clinical decision support (CDS) systems, and best practice alerts (BPAs). Regarding outcomes, out of 8 EHR-driven health coaching interventions, only 3 (38%) reported significant results. In contrast, all the included studies related to CDS and BPA applications reported some significant results with respect to improving hypertension management. CONCLUSIONS: This review identified several use cases for the integration of the EHR in supporting primary care interventions to strengthen hypertension management in racial and ethnic minoritized patients in the United States. Some clinical-based interventions implementing CDS and BPA applications showed promising results. However, more research is needed on community-based interventions, particularly those focusing on patients who are Asian American, American Indian/Alaskan Native, and Native Hawaiian/Pacific Islander. The developed taxonomy comprising "identifying patients," "driving intervention," and "monitoring results" to classify EHR-driven approaches can be a helpful tool to facilitate this.