This study evaluates the ecology of Streptococcus pneumoniae (SP) nasopharynx (NP) colonization in response to the pneumococcal conjugate vaccines, specifically 7-Valent Pneumococcal Conjugate Vaccine (2000-2009), 13-Valent Pneumococcal Conjugate Vaccine (2010-2023) and 20-Valent Pneumococcal Conjugate Vaccine (2023-future date). It is anticipated that the replacement of PCV13 with PCV20, a pneumococcal conjugate vaccine with 7 additional polysaccharide conjugates to CRM197 will enhance the protection against non-vaccine serotypes which are in circulation in communities. The project will evaluate the dynamic changes in pneumococcal colonization over the 5-year time line from 2021-2026. Pneumococcal nasopharynx colonization is detected through nasopharyngeal culture and molecular techniques. The primary source of pneumococcal transmission occurs among the pediatric population and between children and adults. The impact of PCV7 and 13 on pneumococcal colonization over the prior 20 years created a herd effect that resulted in a reduction in pneumococcal disease in unimmunized children and adults. Studies of NP colonization has led to a deeper understanding of pneumococcal conjugate vaccine (PCV) effectiveness and the role of herd immunity in protecting the population, the emergence of replacement serotypes, the variation in invasive capability of each serotype and evolution of antimicrobial resistance resulting from the evolving ecology. In this 5-year-study, researchers at the Pelton Lab in Boston Medical Center set out to understand the prevalence of NP carriage of 13vPnC serotypes, the 7 unique 20vPnC serotypes and NVST (non-vaccine serotypes) within the pediatric population prior to and subsequent to the introduction of PCV 20 (Fall 2023).

Background: The Hispanic community has historically faced high rates of vaccine hesitancy when compared to their non-Hispanic white counterparts. This not only poses a threat to their individual health, but also to their community. In a population that is disproportionately affected by COVID-19 infections, it is critical to address vaccine uptake concerns to control the pandemic and prevent future spread of infections. Objective: This study aims to explore Spanish speakers' vaccination decisions and to explore whether improving health literacy would be an effective approach in increasing vaccination rates. The secondary objective is to describe the role of physicians in decreasing vaccination hesitancy within the Hispanic community. Methods: A review of literature was conducted using articles from 2000 to 2022 focusing on the relationship between the Hispanic community and vaccines, as well as the Hispanic community's health literacy levels. Multiple databases were utilized, and research included the effects of improving health literacy for the Hispanic community in the United States and reasons for vaccine hesitancy in the Hispanic population. From the literature review, 40 articles met the inclusion criteria and were used to determine whether improving health literacy is an effective avenue for increasing vaccination rates in the Hispanic community. Results: A gap of research exists examining the relationship between health literacy and vaccine hesitancy in the Hispanic populations. Studies suggest three main reasons for reduced vaccine uptake for Latinos: the lack of knowledge about vaccines, the need for provider recommendations, and the inability to access healthcare. The studies also ii identified different methodologies in improving both vaccine hesitancy and health literacy. Conclusions: Health literacy may be able to address each of the three main concerns for vaccine hesitancy in the Hispanic population. Thus, research in the future should explore the relationship between health literacy and vaccine hesitancy. Keywords: health literacy, Hispanic, vaccine, vaccine hesitancy

Influenza epidemics continue to cause morbidity and mortality within the human population despite widespread vaccination efforts. This, along with the ominous threat of an avian influenza pandemic (H5N1), demonstrates the need for a much improved, more sophisticated influenza vaccine. Our group has developed an in vitro model system for producing a membrane-bound Cytokine-bearing Influenza Vaccine (CYT-IVAC). Numerous cytokines are involved in directing both innate and adaptive immunity and it is our goal to utilize the properties of individual cytokines and other immunomodulatory proteins to create a more immunogenic vaccine. Here we report methodologies for the construction of membrane-bound cytokine fusion constructs in which our cytokine of interest (mouse GM-CSF, mouse IL-2, mouse IL-4) was fused to the membrane anchoring regions of viral Hemagglutinin (HA). Progeny virions, produced from influenza infected MDCK cells expressing membrane-bound cytokines, readily incorporated membrane-bound cytokines during budding and these cytokines on the virus particles retained bioactivity following viral inactivation. In vivo vaccination studies in mice showed enhanced antibody titers and improved protection following lethal challenge in those mice vaccinated with IL-2 and IL-4-bearing CYT-IVAC's compared to the conventional wild-type vaccine without membrane-bound cytokines. In addition, the immune response induced by IL-2 and IL-4-bearing CYT-IVACs was skewed toward Th1 (cellular) mediated immunity compared to the Th2 (humoral) dominated response induced with wild-type vaccination. Cellular mediated immunity afforded by IL-2 and IL-4 CYT-IVACs was manifested as enhanced influenza specific T cell proliferation and activation. In conclusion, we have developed a novel methodology to introduce bioactive membrane-bound cytokines directly into virus particles in order to augment the immunogenicity of inactivated, whole virus influenza vaccines. / Ph. D.

Influenza epidemics and pandemics remain a significant burden to world health and economy. Low efficacy of current inactivated influenza vaccines in the elderly and immunocompromized and the inability to protect against antigenically drifted or shifted strains of influenza virus are the two major problems in influenza vaccine research. To overcome these hurdles, we have utilized an in vitro cell culture vaccine platform, which results in whole inactivated influenza vaccine (WIV) bearing bioactive membrane-anchored immunomodulatory proteins such as cytokines on the virion surface, collectively known as CYT-IVACs (Cytokine bearing-Inactivated Vaccine). In addition, we tested whether a multimeric M2e peptide presented on WIV can serve to enhance immunogenicity and augment protective efficacy of whole virus vaccines. Our panel of cytokines includes IL-2, IL-4, IL-12, IL-23, and Flt3L as well as the multimeric M2e peptide, all fused to the membrane anchoring regions of influenza virus hemagglutinin protein and constitutively expressed in virus permissive MDCK cell line. Subsequent infection with influenza virus results in incorporation of fusion constructs directly into budding progeny virions that are harvested, purified and inactivated to generate distinct CYT-IVAC formulations. Following validation of immunomodulator incorporation, vaccines were tested for in vivo efficacy in either "young adult" or "aged" female Balb/c mice. Our results demonstrate that our CYT-IVAC~IL-12/HA and CYT-IVAC~IL-23/HA serve as potent mucosal adjuvants in young adult mice elicited significantly high levels of mucosal IgA antibodies and afford superior protection against lethal virus challenge. Our Flt3L/HA formulation was the most effective stimulator of systemic anti-viral antibody levels. In "aged" mice a single dose formulation of IL-12 bearing CYTIVAC was superior at affording protection against lethal homotypic virus challenge. Finally, administration of multimeric M2e molecule co-presented on WIV elicited prolonged antibody responses in "young adult mice" and provided cross-protection from challenge with the heterologous influenza A pandemic strain 2009 H1N1. In conclusion, the CYT-IVAC approach represents a novel tailored advancement to current WIV approaches that has the potential to elicit both potent mucosal and systemic immune responses in young and old. / Ph. D.

INTRODUCTION: With the rise of non-traditional providers offering influenza vaccination, it is becoming more of an endeavor to obtain documentation on vaccination. Researchers are relying more on self-report of vaccination, but the accuracy of differing definitions of self-reported vaccination status in the context of inpatient vaccine effectiveness studies is not well understood. OBJECTIVES: The first objective of this study was the assess agreement among four different definitions of self-reported influenza vaccination compared against documented influenza vaccination in a group for whom documented vaccination is expected to be available. For the definition with best agreement, enrollee characteristics were examined to assess which were associated with agreement between definitions. The second objective was to assess the effect of ten different vaccination status definitions, including variations of self-report and documented vaccination, on vaccine effectiveness (VE). METHODS: We used data from the inpatient component of the US Flu VE Network study of VE in patients hospitalized with acute respiratory illness (ARI). Variations of self-reported vaccination status were defined and compared to documented vaccination status. Agreement was assessed using the kappa statistic of agreement and other measures of agreement. VE was measured using logistic regression controlling for certain patient demographics and illness characteristics. RESULTS: Self-report with date had the highest percent agreement and kappa statistic (79.5%; 57.7%, 95% CI: 50.1, 65.2). Those in the oldest age groups (18-49 and ≥65 years) and those influenza positive were more likely to have agreement between self-reported vaccination with date and documented vaccination status (p < 0.05 for both age group and case status). Estimated VE differed three-fold depending on definition of vaccination, with documented vaccination having the lowest VE (10%, 95% CI: -54, 48) and self-reported vaccination with date and location having the highest VE (37%, 95% CI: -10, 64). CONCLUSION: Defining vaccination status using self-reported vaccination with date provides the most accurate classification of vaccination status. Older adults and those with lab-confirmed influenza were more accurate in their self-report of influenza vaccination. Differing definitions have an impact on estimated VE, and understanding how VE is influenced by choice of vaccination status definition is important to examine and report in studies of influenza VE.

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