Recent Submissions

  • Development and Evaluation of Micro/Nanoparticulate Vaccines for Human Papillomavirus and Influenza

    Vo, Trinh; College of Pharmacy
    Influenza and Human papillomavirus (HPV) are among the most common infectious deseases prevalent globally. The influenza viruses cause approximately 200,000 hospitalizations each year, resulting in a significant financial burden to the healthcare industry. Similarly, HPVs cause virulent infections that have multiple serotypes capable of producing genital warts and cervical cancer. In both cases the infection is spread through viral agents, The influenza virus is transmitted by aerosolized mist of coughs and sneezes with HPV is a sexually transmitted disease. Prevention of influenza and HPV is possible with the help of vaccines, and currently, there are several vaccines for both infectious diseases. However, in the case of influenza, development of a vaccine is challenging as the virus undergoes rapid mutations and hence, the vaccine needs to be modified every season. Along with the constant need for vaccination rates. In the case of HPV, the need for a novel vaccine delivery system is more crucial. HPV is directly linked to cervical cancer and developing a novel strategy to improve vaccination globally is a major priority. Commercial vaccines are not only expensive but in developing countries the financial cost of maintaining cold storage and vaccine administration is significantly challenging. The developing non-parenteral vaccines is essential to improve patient compliance without affecting safety and efficacy of the vaccine. This project has two main sections focusing on development of an oral microparticulate vaccine for influenza and HPV. In the first part of this project, we developed an oral microparticulate vaccine for influenza. The influenza vaccine consists of a M2e protein which is a viral protein common to all influenza viruses encapsulated into a microparticle. Adjuvants such as Alum, MPL. R848, MF59, Flagellin, CpG and P4 were encapsulated in microparticles separately. Microphages werestimulated with the vaccine-adjuvants combinations and subsequently., splenocytes were incubated with activated macrophages to investigate the T-cell activity. We observed significant enhancement of immune markers such as nitric oxide, CD80, CD86, and MHC II with several adjuvants. Furthermore, CD4 and CD8 T cell expression was also significantly enhanced in groups treated with particulate adjuvants. In the second part of this project, we formulated a novel oral and transdermal vaccine delivery system for HPV. Development of potent vaccines against HPV can prevent serious complications such as genital warts and cervical cancer. Therefore a novel non-parenteral vaccine against HPV may significantly reduce incidence of HPV worldwide. In this study, three different microparticualte vaccine formulations have been prepared and characterized: Bovine Albumin Serum (BSA) cross0linked with glutaradehyde; b-cyclodextrin, and cellulose acetate succinate matrices. We systematically studied activation of the immune markers such as nitirc oxide. CD80, CD86, CD40 and MHC-II. In vivo studies demonstrated elevated humoral and cell-mediated immune response in murine models. We observed elevated IgG titers in mice vaccinated with microparticulate HPV16 VLP vaccine, Furthermore, flow cytometry analysis revealed expansion of specific T-cell populations in vivo. This study proves the efficacy of the HPV-16 oral microparticulate vaccine as a promising alternative to conventional vaccines, In the alter part of the HPV vaccine project we investigated the potential of transdermal HPV vaccine as a novel strategy to improve vaccinations globally. In order to combat HPV infection, vaccines must be affordable, self-administered and efficacious. Transdermal vaccines can be self-administered. are almost painless and tap the immune cells present under the skin. Transdermal vaccines have gained immense attention due to their efficacy. In this project, our main aim was to develop a microparticulate HPV16 VLP vaccine for transdermal vaccination. HPV-16 VLP was encapsulated in microparticles and characterized for size, zeta potential, encapsulation efficiency and microparticle yield. Scanning electron microscope images confirmed the particles were irregular with surface indentations. Western blot analysis was performed on HPV16 VLP extracted from microparticles, which confirmed the retention of antigenicity of the epitope following microparticles, which confirmed the retention of antigenicity of the epitope following microparticle fromulation. Following in vitro characterization studies, we performed extensive in vivo studies to investigate the potential of the microparticulate vaccine to initiate a robust and sustained immune response. IgC titers for mice vaccinated with microparticulate vaccine were significantly elevated as compared to antigen solutions adminstered by the transdermal route. Flow cytometry was performed on vaccinated and control groups to investigate the expansion of specific T-cell populations. Vaccinated mice demonstrated significant increase in CD4, CD45R, CD27 and CD62L cell populations. Expansion of these specific T-cell subsets demonstrates the efficacy of the microparticulate vaccine when administered transdermally. Thus, our study proves the efficacy of the microparticulate vaccine over vaccine solutions and the novel approach of administering the vaccine through a minimally invasive, pain-free route that will help to improve acceptability of vaccination against HPV.
  • Oral Microparticulate Prostate Cancer Vaccine: A Promising Immunotherapeutic Approach

    Parenky, Ashwin; College of Pharmacy
    Prostate cancer is one of the leading causes of cancer-related deaths among men in the United States. Currently, there are 5 new agants approved in the United States against prostate cancer which include Sipuleucel-T, cabazitaxel, abiraterone acetate, enzalutamide and radium-223. Introduction of these agents into the clinic are important strides; however, resistance to chemotherapeutic agents is still a significant challenge, Furthermore, when patients suffer from recurrence of prostate cancer, survival is less than five months. Hence, there is an urgent need to investigate alternative approaches to treat castration resistant prostate cancer and prevent relapse. Immunotherapeutic approaches to treat cancer are under intense investigation owing to their specificity and potency to eliminate tumors. One of the most intensely studied areas in the cancer research is identification of cancer antigens that can help indicate progression of cancer, in certain scenarios these antigens may also serve as vaccines for cancer immunotherapy. These cancer antigens are important because they boost the immune system to specifically recognize and kill tumors. In our studies, we have investigated two different antigens to combat prostate cancer. Sperm protein-17 and tumor associated antigens extracted from TRAMP C2 murine prostate cancer cell line were investigated as potential therapeutic vaccines. The above mentioned antigens are proteins and protein antigens themselves have poor bioavailability and absorption thus making it difficult to initiate immune response against the cancer. Particulate delivery systems encapsulating protein antigens have been proved to improve the delivery and efficacy of vaccine responses. Thus, particulate delivery systems are crucial in improving the delivery of these potent cancer antigens for a sustained and systemic anti-cancer activity, Another important aspect of vaccine delivery is the route of vaccination owing to its patient compliance and ease of administration. However, several challenges such as harsh gastric environment and tolerance induction has hindered successful clinical effectiveness of oral vaccines. Adjuvants have always been administered along with vaccines for decades. FDA approved vaccines such as Gardasil and Cerverix both have adjuvants to boost immunity. Thus, identifying appropriate adjuvants that will help boost anti-tumor activity is paramount. In order to increase the potency of our vaccine, several toll-like receptor (TLR) and non-TLR adjuvants were also studied. In this study, we have developed an oral microparticulate vaccine encapsulating two distinct antigens against prostate cancer. SP17 and antigens extracted from murine prostate cancer cell line were encapsulated separately in microparticles. Microparticulate vaccines were characterized for their physiochemical properties in vitro and evaluated for their antigenicity on murine dendritic cells. In order to protentiate vaccine efficacy, we also included adjuvants in microparticulate formulations and evaluated their potential to enhance the antigenicity of our vaccine formulations. SP17 administration. Several adjuvants such as R848, MPL, MF59 and alum were selected for future studies in vivo studies. The second part of this project focuses on formulation of a microparticulate vaccine encapsulating tumor associated antigens extracted from a murine prostate cancer cell line (TRAMP C2). We investigated the potential of our formulated vaccine along with two adjuvant microparticles, ALUM and MF59, to boost anti-tumor response against prostate cancer. Finally, to prove the effectiveness of our vaccine and overcome the tumor "immune escape" mechanism in cancer, we also performed a therapeutic in vivo study on a murine prostate cancer model. Encouraging results from the in vivo study demonstrate excellent anti-tumor activity of our therapeutic vaccine. We observed a significant reduction in tumor volume and sustained anti-tumor T-cell activity in vivo. Thus, we could also demonstrate , in our experiments, the importance of combination therapy which inhibits cancer "immune escape" mechanisms and improves vaccine efficacy.
  • Overian Cancer Microparticulate Vaccines: Effect of Routes of Administration

    Tawde, Suprita Ashok; College of Pharmacy
    Ovarian cancer is the most lethal gynecological cancer in the U.S. First-line treatment for advanced cancer involves surgery followed by chemotherapy. However, cancer relapses within short periods of time even after treatment. Therefore, alternative approach of immunotherapy is being investigated. We studied vaccination with microparticles containing the ovarian cancer antigens can prevent/retard ovarian cancer growth. Oral and transdermal routes are attractive modes of immunization because of their ease of administration and patient compliance. In this project we explored microparticulate system to target immune cells and to initiate response against ovarian cancer antigens via oral, subcutaneous and transdermal delivery. We selected a murine cell line which correlates closely to human cell line in terms of antigen expression and tumor formulation. We prepared the antigenic lysate and characterized it for the presence of a known antigen. We loaded micro-particulate delivery systems with the lysate. These particles were formulated with desired physical properties suitable for particle uptake and for anticipated immune response. In the present study, we demonstrate the efficacy of vaccine formulations wuth was evaluated in vivo in mouse tumor model, using the murine ovarian cancer cell line as a solid tumor model via oral, transdermal, subcutaneous and via combination of oral and transdermal routes. The tumor volumes upon challenge with live tumor cells were monitored in vaccinated animals and control animals. Humoral and cellular immune response in all the animals were monitored to determine the immune mechanism initiated by the vaccine microparticles. Encouraging results from these prophylactic particulate overian cancer studies provided the basis to design therapeutic study to mimic the real-time scenario where patients with residual tumors after a surgery are the recipients of such vaccine therapy. Further, to elucidate the role of M-cells in particle uptake once administered orally, we induced M-cells in murine models and administered microparticles loaded with a model antigen with and without immune adjuvant. The immune response generated via these vaccine particles in mice models with induced M-cells was compared to control animals, to determine whether particles followed the M-cell pathway for their uptake in order to trigger immune cells.
  • Development of Microencapsulated Formulations for Prostate Cancer Vaccine and Live Cells

    Akalkotkar, Archana; College of Pharmacy
    In the current trend, novel particle based platform technology has paved its way to various therapeutic benefits in our lives. In this study, we explored the way of harnessing this technology in order to formulate effective vaccines in the quest for mass immunization in a cost-effective manner. Here we propose a custom formulation of vaccines, which will render effects of sustained release, site specificity and cost-effective delivery of various antigens to enhance the immunity. We used the novel nano-micro technology based of Spray drying as a platform to deliver vaccines against Prostate cancer and encapsulated live cells. In this study, we formulated a whole cell lysate vaccine against prostate cancer via oral and transdermal route of administration. The formulation intended for oral adminstration was optimized for M-cell targeting, The formulation increased the immunogenicity of the vaccine by incorporating the antigen into an albumin matrix having a size of around 0.35-1.2 um that acted as a synthetic adjuvant. The animals were vaccinated with 1 prime and 4 booster doses administered every 14 days over 10 weeks duration, followed by challenge with live tumor cells which showed protection after oral vaccination. Unlike subcutaneous injections, administration-using microneedles is painless and in general can increase the permeability of many compounds ranging in size from small molecules to proteins and microparticles that do not normally penetrate the skin. The mice vaccinated via transdermal route showed promising results in delaying the tumor growth compared to the controls. The study was extrapolated in a therapeutic approach. This would mimic the real clinical scenario where the patient who was diagnosed with prostate cancer would come in the clinic for immunotherapy. The microparticle based delivery system showed protection in vaccinated group compared to the controls. This shows the microparticle based delivery system can be an useful tool for delivery as well as live cells in vivo.
  • Formulation and In Vivo Evaluation of Particulate Breast Cancer Vaccine

    Chablani, Lipika; College of Pharmacy
    Purpose: This research work concentrates on formulating two particulate breast cancer vaccines, which are further evaluated in vivo using two murine breast cancer models. As breast cancer continues to be the most fatal cancer among women throughout the world, there is an immediate need to develop a vaccine to combat it. Considering the potential of particulate delivery vehicles to impart robust systemic as well as mucosal immune response, they have been explored not only against infectious diseases but also against cancer. In this project we take advantage of these micron sized particulate delivery vehicles to target immune cells and to initiate immune response against breast cancer antigens, Also, these particles have been fabricated in such a manner that they can be administered via patient-compliant routes of administration including oral and intraepidermal delivery. Research methodology: We have explored various polymers to optimize two enteric protected particulate delivery systems with desired physical properties making them susceptible to particle uptake and there by leading to anticipated immune response. These particles have been evaluated carefully for their size, charge, surface morphology, release profiles, cyto-toxicity and particle uptake by various in vitro studies. Further the particle uptake of vaccines by the M (microfold) cells in the Peyer's patches of the small intestine when given orally is studied extensively along with characterization of microchannels created to deliver the microparticulate vaccine. Also, the vaccine efficacy was evaluated in vivo in female mice model using the two marine breast cancer cell lines which mimic the progression of breast cancer as seen in humans, The vaccine was administered via oral, intraepidermal and sub-cutaneous routes resulting in immune response against the breast cancer antigens used in the vaccine. Results and Conclusion: The vaccinated animal had sugnificantly smaller tumor volumes than the control animals, as seen after challenging the animal upon termination of treatment. Immune responses in all the animals were monitored to gauge the role of humoral and cellular immunity in generating protection by several in vitro and ex vivo studies. Promising results from these two prophylactic particulate breast cancer vaccine studies have advanced our laboratory to explore a therapeutic breast cancer vaccine. These particulate delivery systems possess the potential of entering the clinical trials and mimicking the real-time situation where patient's own tumor cells extracted after a surgery can serve as the source of antigens for an individualized particulate vaccine.
  • Formulation and Evaluation of Microparticulate System for the Development of Pneumonia and Influenza Vaccines

    Nagaraja Shastri, Prathap; College of Pharmacy
    In recent years vaccine research has gained a tremendous interest from both industries as well from the academic sectors. There are number of vaccines available in the market and still there is a scope of improvement in most of the marketed vaccines. The antigens used in vaccination are in general large molecules, either protein or polysaccharide based. These antigens can lead to specific antibodies that will protect our body from the infection. Some of the antigens are stable, however majority of them are instable and sensitive resulting in problems during formulation, storage. Formulation of protein or polysaccharide has always been a challenge for scientists due to several characteristics of the antigen and the dosage from itself. Microparticle is on the the dosage forms that have shown promising results in several vaccine studies in the past. In this study we have evaluated microparticle formulations for two infectious diseases namely, Pneumonia and Influenza. Both these are respiratory infections and the vaccinations against these are highly recommended by the Center for Disease Control. In particularly for Influenza the vaccination is recommended every year. In this research we have used two novel approaches to formulate these antigens using microparticles. The pneumococcal polysaccharide antigens are usually less immunogenic in nature and hence to potentiate their immune response the antigens were formulated in a cross linked albumin matrix. In case of Influenza vaccines, we have attempted to vaccinate via oral route of administration after formulating inactivated form of influenza virus in an enteric coated microparticle formulation. Upon formulation both theses vaccines were characterized for their physical properties such as particle size, zeta potential and also the bioactivity of these antigens in microparticles were measured using antigen specific bio assays, Further invivo studies were carried out in mice to evaluate the adaptive immune responce elicited by microparticle based vaccines. The results have been promising with increase in antibody titers for vaccine formulations and also better protection was observed in case of Influenza vaccine, Overall these promising results further emphasize the use of microparticles as a tool to deliver vaccine antigens effectively.
  • Formulation Develoment and Characaterization of Polycaprolacton/Pluronic F108 NanoParticles for Targeted Breast Cancer Therapy

    Chandran, Thripthy; College of Pharmacy
    Breast Cancer ranks first among cancer deaths for women after malignant lung cancer in the United States. Despite the major advancements in the treatment of breast cancer, it still poses a major challenge. While chemotherapeutic intervention remains the major treatment approach fr cancer, they suffer from several drawbacks including dose limiting toxicity, non-specific biodistribution, and emergence of resistance in solid tumors, thus posing a risk of relapse. Furthermore, the excipients used for the administration of the anticancer agents also cause several undesirable systemic effects such as nephrotoxicity, neurotoxicity, and hypersensitivity reactions when given intravenously. Biodegradable polymeric nanoparticles have emerged as promising targeted drug delivery systems for the delivery of anticancer drug owing to their size characteristics., their ability to passively accumulate by Enhanced Permeability and Retention (EPR) effect in the tumors, ability to protect the active ingredients from degradation, providing a controlled/sustained release of the active ingredients and b tunable for the attachment of active ligands according to a patient's tumor profile and thus provide a personalized therapy. In this study, we designed polymeric nanoparticles for the delivery of anticancer agent docetaxel using poly-e-caprolactone (PCL), which forms the core of the the nanopartilces. Pluronic polymer F108 is used as an emulsifying agent/stabilizer for the PCL nanoparticles, providing a hydrophilic PEG coating thus stealth properties to the nanoparticles. The passive targeting ability of the nanoparticles is evaluated using a near infrared carbocyanine dye (Dir). Trastuzmab is used as an active targeting ligand to target the HER-2 receptors present on the human breast cancer BT-474 cells. Thus, this project focuses on the formulation development, in vitro characterization of docetaxel loaded nanoparticles and finally the characterization of trastuzumab conjugated nanoparticles.
  • Development of Spray Dried Microparticulate Delivery Systems for Vaccines and Oligonucleotides

    Ubale, Ruhi V; College of Pharmacy
    In recent years, research related to the development of biotherapeutics has gained tremendous interest in industry as well as academia. There are a number of biologics available in the market and many more currently being evaluated in clinical trials. Their development has gained momentum due to the range of advantages they offer over traditional small molecule drugs. However, there still remain challenges with their delivery mainly due to the poor stability of these molecules in harsh physiological conditions. A number of strategies are being devised for the delivery of biomolecules by non-invasive routes to make delivery easier and more patient compliant. Microparticles are one of the options being explored as they offer protection, sustained release and enhanced bioactivity to the biomolecule. In this project, we have studied the use of microparticles for the development of formulations for a meningococcal polysaccharide vaccine and an antisense oligonucleotide to NF-kB. Meningitis occurs majorly in children and is caused by Neisseria meninigitidis. Infection by this bacterium spreads rapidly through the body resulting in loss of limbs, hearing and can also be fatal. Hence, vaccination is considered as the only means prevention for meninigitis. Marketed vaccines use protein conjugated bacterial capsular polysaccharides as the antigen. Polysacchatides are considered inherently weak antigens with a T- independent immune response. With the development of a microparticulate vaccine using a protien matrix, we expected to stimulate the T-dependent immune pathway for these antigens avoiding the use of a conjugated Diphtheria toxoid. We have studied the enhancement of innate immune responses by the microparticulate vaccine. The antigen used N. meningitidis polysaccharide A, aslo an adjuvant- kdtA(unglecosylated lipid A)- was studied for its response. The microparticulate vaccine was characterized for its physicochemical characteristics like size, charge and toxicity. Also it was studied for the innate immune responses the microparticles can elicit after incubation with murine and human macrophages. Release of innate immune markers like TNF-a, IL-1B, IL-8, nitric oxide and reactive oxygen species from macrophages was studied and the microparticulate vaccine was observed to elicit a desirable innate immune response. Antigen presentation by macropaphages stimulated with the microparticulate vaccine was also studied by visualizing autophagy. Lung inflammation occurs doe to an infection or a damaging agent that irritates the lung lining or pleura. NF-kB is a nuclear transcription factor activated by stimuli like endotoxin and bacteria that initiates the synthesis of pro inflammatory cytokines such as TNF-a, IL-1, IL-6, etc. Antisense are single stranded RNA complementary to a chosen sequence that offer great potential to inhibit the synthesis of individual proteins by interfering with protein translation. As intracellular penetration of antisence compounds has proven to be a limiting factor in their effectiveness, we have proposed to develop a microparticulate formulation for pulmonary delivery of antisense to NF-kB and evaluate their efficacy. The microparticulate formulation of antisense to NF-kB was characterized for its physiochemical characteristics like size, charge, antisense content and release. Since enhancing uptake into cells was the crux of the study, we also visualized and quantified uptake of microparticles by microphages. We looked at the period of lung resistance and the biodistribution of the microparticles using a near infrared bioimager. Serum levels of proinflammatory cytokines were studied after induction of lung inflammation in a rat model. Animals that were delivered antisense microparticles to the lung showed reduced levels of TNF-a and IL-1b.
  • Formulation Design and Development of Theranostic Nanoparticles for Tumor Targeted Drug Delivery

    Kolluru, Lakshmi Prasanna; College of Pharmacy
    Cancer is among the leading cause of death in the world, accounting for one in every four deaths in United States. Researchers from academia and industry are working on discovering new drug targets, developing better drug products and enhancing efficacy of drug delivery systems. In spite of the advancements, drug delivery still remains a challenge in the management of cancer. Currently, Chemotherapy (mostly in combination with radiation) is a major therapeutic approach for the treatment of cancer. However several chemotherapeutic drugs lack the ability to differentiate between normal and tumor tissues and suffer from drawbacks such as dose limiting toxicity, low specificity and emergence of multidrug resistance. Major concerns associated with current anti-cancer agents which are gaining wide importance include rapid elimination from kidney and non-specific biodistribution. In addition, the rapid clearance of the drug from the body might require administration of larger doses which can cause toxic effects. One approach to reduce the systemic toxicity and enhance the efficacy of the drugs us to administer through selective drug delivery carriers. Polymeric nanoparticles offer promise for targeted drug delivery as they have the potential for passive targeting of drugs by Enhanced Permeable and Retention (EPR) effect, controlled/sustained release of drug, reduced clearance and ability for surface fuctionalization with tumor targeting ligands. In this studym we have successfully fabricated polymeric nanoparticles for the delivery of diagnostic and therapeutic agents using Bovine Serum Albumin (BSA) polymeric nanoparticles. Near Infrared dye, Indocyanine green and anti-cancer drug, Doxorubicin are used as model diagnostic and therapeutic agents respectively. Folic acid and cyclic RGD are used as tumor targeting ligands to target tumor microenvironment and tumor cells. This project focuses on the preformulation, formulation development, in vitro characterization and in vivo evaluation of the drug-dye loaded nanoparticles and evaluation of the active targeting potential is proposed. Spray drying and Nanoprecipitation techniques are evaluated and nanoprecipotation technique is used in final preparation. Nanoparticle suspension was then subjected to lyophilization. The formulation is further extensively characterized in vitro by Dynamic light scattering (DLS), Release Studies, Differential SCanning Calorimetry (DSC) and MTS Cytotoxicity Assey. In addition, the formulation is also evaluated in vivo for its tumor targeting potential by monitoring the biodistribution of entrapped near infrared dye using whole body non-invasive imaging technique. Results of our work demonstrated that diagnostic and therapeutic agents can be effectively delivered in a single delivery system. Our work further emphasizes that nanoparticle based system can enhance localization of diagnostic (or therapeutic agents) into the tumor, thereby contributing to reduces side effects and enhanced efficacy.
  • Development and Characterization of a Novel Immunotherapy for Treatment of Breast Cancer by Combining Particulate Cancer Vaccines with Immune-Modulators

    Mulla, Nihal S; College of Pharmacy
    In the last half of the century, advances in the field of cancer therapy including chemotherapy, hormonal therapy and targeted therapy have been responsible for improvements in breast cancer related mortality. Although such advances have benefited all cancer types, there are considerable challenges faced by researchers striving to realize the goal of complete tumor remission. Immunotherapy is a great alternative as it has minimum side effects and several advantages over traditional cancer therapies. The aim of this project is to develop a novel immunotherapy for treatment of cancer by combining cancer vaccines with various immune-modulators. We take advantage of micron-sized particles to deliver vaccine along with other immune modifiers to target immune cells and to initiate immune response against breast cancer antigens. These particles were evaluated for their size, charge, surface morphology, release profiles, cyto-toxicity and particle uptake by various in vitro studies. The efficacy of breast cancer vaccine microparticles was tested in a murine breast cancer model. The immunized animals showed significantly lower tumor growth compared to the naive animals that did not receive any treatment. The delay in tumor growth in vaccinated animals was due to a strong immune response generated against tumor- associated antigens encapsulated within the microparticles. We observed a significant increase in the CD4+ T cell population. The suppression mechanism employed by regulatory T cells are thought to contribute significantly to the failure of current therapies that rely on potentiation of anti-tumor responses. We evaluated the therapeutic efficacy of vaccine microparticles after depleting the immunosuppressive regulatory T cells. We observed a significant improvement in the efficacy of vaccine microparticles by depleting regulatory T cells. The tumor inhibitory effect of vaccine microparticles was due to depletion of regulatory T cells by cyclophosphamide. We observed a significant increase in the CD8+ T cell population. The final aim of my research project was to enhance the immunogenicity of cancer vaccines using adjuvants. Based on our findings we conclude that Alum, Addavax (like MF59) R848 and CpG significantly enhanced the immunogenicity of breast cancer associated antigens.
  • Consensus Definition of Self-Love: A Delphi Study

    Underwood, Jack; College of Professional Advancement
    CONSENSUS DEFINITION OF SELF-LOVE: A DELPHI STUDY Abstract This study produced a consensus definition of self-love, counseling uses, and outcomes. Self-love is a concept written about but minimally researched. Research investigating a definition of self-love includes the dissertations of Patrick (1982), Freedman (1995), Irvani (2007), and Samiei (2015). These authors define self-love based on comprehensive reviews of research and psychology literature, philosophical underpinnings, theoretical frameworks of Erich Fromm and Carl Rogers, and a panel consultation of psychologists. This study sought to establish a valid research definition of self-love through the use of the Delphi research method. Fully licensed counselors, social workers, marriage and family therapists, and a psychiatrist comprised the initial 25-member Delphi expert panel. The consensus definition of self-love was constructed largely with components of self-care, self-worth, self-acceptance, and unconditional positive self-regard. A distinct panel outcome, was the consensus that self-love is both an individual and dual process, revising previous literature suggesting the dual process model only. The panel produced near perfect consensus on two definitions of self-care that were extremely important to the definition of self-love: a practice of self-compassion and self-empathy, and the act of nurturing the whole self. Three research questions were utilized to produce an initial definition of self-love which then went through the multiple iteration process to reach the consensus definition for the study. The panel agreed on 20 ways a definition of self-love can be used in counseling in addition to 23 positive outcomes that might be associated with clients who receive counseling focusing on self-love. Keywords: self-love, Delphi, research validity, expert panel, consensus agreement
  • Impact of Spirituality on Occupational Success of Individuals with Spinal Cord Injury

    Pegues, Sir Allen Dupree; College of Professional Advancement
    ABSTRACT SIR ALLEN D. PEGUES IMPACT OF SPIRITUALITY ON OCCUPATIONAL SUCCESS OF INDIVIDUALS WITH SPINAL CORD INJURY Under the direction of SUNEETHA MANYAM, PhD The literature findings indicate that individuals with spinal cord injury (SCI) are less likely to obtain employment than people without disabilities. Challenges such as resiliency, spirituality, level of education, and the severity of the injury contribute to their lack of employment. Individuals with SCI should have the same opportunity to achieve occupational success as persons without disabilities. This study was designed to explore the following question: What impact does spirituality have on the occupational success of individuals with SCI? The researcher used the Spiritual Well-Being Scale and Connor-Davidson Resilience Scale to measure each participant’s level of resiliency and spirituality. Convenience sampling was used to collect data from 117 SCI individuals who responded to a Qualtrics survey. The data were analyzed using the ANOVA procedure to gain an understanding of how the independent variables impacted the occupational success of individuals with SCI. The results revealed that resiliency and level of education had a statistically significant impact on occupational success of individuals with SCI. Individuals with SCI with higher spirituality scores did not have as much occupational success as those with lower spirituality scores. Individuals with more education had more occupational success than individuals with SCI with less education. The severity of the injury did not have a statistically significant impact on occupational success of individuals with SCI.
  • Beyond Borders: A Christian Ethical Response to Border Control in the United States

    Ball, Jeremy A; McAfee School of Theology
    Border control is a sociopolitical issue in the United States that has ignited heated conversation and, in some cases, caused division among U.S. citizens. In the midst of seeking solutions to better secure our nation’s borders, many have neglected the fact that there is currently a human crisis at the southwestern border. Thousands of migrant children have been separated from their families and are now forced to live in detention centers where there is a lack of food and proper shelter. There have also been numerous deaths for those attempting to cross our border. Keeping in mind the suffering, the objective of this study is to suggest a Christian ethical response to the crisis at the border. Providing a political analysis of border control and an exegetical study of biblical passages that may be applicable to the current crisis, this thesis proposes principles and policies that U.S. Christians must embrace in order to see the suffering come to an end. While border control is an issue worthy of recognition, my thesis concludes that the well-being of migrants must be prioritized above other matters and that neutrality in the midst of suffering is not a virtuous option for Christians.
  • On the Shoulders of Giants: Helping Students Understand Mathematics through its History

    Henderson, David K; Tift College of Education
    The IDEAS curriculum and instruction model was designed to help secondary students better understand mathematics by incorporating the historical development of the subject into classroom instruction. IDEAS is an acronym that describes the components of the model: I (Introduce the concept through a hands-on activity); D (Discover the historical, cultural, and human context through biography); E (Examine the primary sources through inquiry); A (Actualize the learning through written reflection); and S (Synthesize the understanding through practice and application). This study examined the effectiveness of the IDEAS model in a secondary setting, with 107 students enrolled in a pre-calculus course at a large suburban Title I public school in the southeastern United States. The IDEAS model was studied in both a classroom (face-to-face) context and a digital (online) context. A mixed methods approach was used, employing a quasi-experimental design, to determine the effectiveness of the intervention (the implementation of the IDEAS model). Quantitative data included pre- and post-intervention questionnaires, content assessments, and written reflections. Qualitative data included written reflections and one-on-one interviews. The main findings of this study were that the IDEAS model (1) increased participants’ understanding of the nature of mathematics (p < .02; d = .66); (2) helped participants develop a more positive attitude toward mathematics and its history; and (3) increased participants’ academic achievement in mathematics (p < .05; d = .33). These results have implications for secondary students, teachers, administrators, and researchers.
  • Mastering the Ropes of the Climb: A Case Study Exploration of Educator Perceptions of Their Preparedness to Teach in Behaviorally Inclusive Classroom Environments

    Fannin, Kaminsia M; Tift College of Education
    This study examined general education teacher perceptions of being prepared to meet the needs of students with emotional and behavior disabilities in inclusive classrooms. Preparation with the knowledge and skills needed for addressing the various needs of students with behavior disabilities is coupled with the metaphorical backdrop of scaling a mountain. This metaphor was used to illustrate the foundational necessity for training of skills and knowledge for tackling the undertaking, as well as the uphill venture it presents. Current research has examined the effect on teacher attitudes for working with EBD students and its influence on student outcomes. However, few researchers have utilized a qualitative case study to explore the relationship of their perceptions to their preservice and in-service (professional learning) preparation. This study implemented a qualitative design through a single exploratory case study methodology. Semi-structured questionnaires, journal reflections, and a focus group was utilized to gather participant experiences and reflections. Findings indicated 10 emerging themes associated with preparation for behaviorally inclusive classrooms. An overwhelming majority of the negative perceptions were associated with preservice and in-service preparation. Positive perceptions were in the areas of student teaching experiences and school-based collaboration/support teams. The positive perceptions found were not associated with preparation provided by either institution but gained by way of experiences while teaching. Recommendation for further study include expanding the participant pool by diversifying the geographic areas and school districts, gathering perceptions from special education teacher regarding the same institutions to compare to the perceptions of general education teachers, and gathering perceptions from students in behaviorally inclusive classrooms regarding their experiences with the teachers in the environment.
  • The Effects of Math Literacy Utilizing a Reading Apprenticeship Framework on Math Achievement of Analytic Geometry Students

    Foster, Karonda Antwanette; Tift College of Education
    This study addresses the issue of a lack of math literacy skills that are necessary for academic achievement. The purpose of this quantitative study was to determine if the literacy intervention, Reading Apprenticeship (Schoenbach, Greenleaf, & Murphy, 2012), effects the student achievement of high school Analytic Geometry students. Previous research suggests that the Reading Apprenticeship (Schoenbach, Greenleaf, & Murphy, 2012) effects student achievement and self-efficacy of students and teachers in science, English, and history. However, no previous research study measured student achievement of Analytic Geometry students. In this study, data was collected and analyzed from 84 students from a suburban high school in Georgia. Due to preexisting schedules, students were conveniently placed into experimental and control groups. The experimental group received the Reading Apprenticeship (Schoenbach, Greenleaf, & Murphy, 2012) during classroom instruction, while the control group received traditional classroom instruction. Both groups of students were administered a pretest and posttest developed by USATestprep. The instrument used was closely aligned to the Georgia Milestones assessment. The posttest results were analyzed using an ANCOVA. There was a statistically significant difference in the mathematical achievement of Analytic Geometry students who receive a literacy intervention using the Reading Apprenticeship model (Schoenbach, Greenleaf, & Murphy, 2012). Recommendations for future research include increasing the sample size, balancing group sizes, implementing the study in a face-to-face classroom setting, and extending research to other topics in mathematics. Recommendations for future practice includes exposure to math text in math classes and an increase of math literacy skills used in math classes.
  • Sister Circles: African American Women’s Sense of Community in Online Learning

    Howard-West, Barbara; Tift College of Education
    Despite the higher enrollment rate of African American women in higher education, they have lower graduation and higher attrition rates than any other ethnic group in online higher education doctoral programs. Limited research exists on African American women’s experiences in online learning. The purpose of this phenomenological study was to document any cohesion that supports a sense of community and retention and explore the personal and academic experiences of African American women enrolled in a hybrid doctoral program at a private White institution as they engaged in a sister circle. A social constructivism epistemology informed the frameworks of critical race feminism and McMillan and Chavis’s sense of community, thus forming the foundation for this study. Interpretive phenomenological analysis (IPA) guided the data analysis process. Nine African American women who self-identified as “Black” participated in a sister circle while matriculating in a hybrid doctoral program. Focus group discussions occurred in an online forum learning management system called Canvas. Interviews were completed via video conferencing using Zoom. The themes of focus on self, focus on feelings, focus on experiences, and focus on connections emerged from the data analysis. The first superordinate theme, focus on self, provided an emotional scrutinizing diagnosis of African American women as they discussed their experiences identifying strategies to persevere in the program. The second superordinate theme, focus on feelings, provided a synopsis of African American women’s feelings related to African American women as a whole, and identify areas that they thought were important. The third superordinate theme, focus on experiences, appeared as the participants discussed their experiences as African American women in the sister circle. The last superordinate theme, focus on connections, arose as the members provided detailed accounts of their connections with one another. Implications for educational policy were to include more counter-spaces for African American women to make meaning of their oppressed and underprivileged experiences. More research is necessary on the effect of sister circles on the experiences of African American women attending private White institutions.
  • Masculinity Perception and Motivational Influences on Male Students' Higher Education Academic Success

    Hallman, Jeff H.; Tift College of Education
    Male higher education students are expected to account for only 40% of the total college and university enrollment and only 40% of the total students who graduate with at least a baccalaureate degree by 2026. The disparity gap trend that began in 1981 has been widening since that year. The level of educational attainment has future consequences to the financial stability and employability that influences skilled, labor-based economies and marriage and childbearing structures. The problem addressed by this study was the declining rate of male undergraduate student educational success. This research sought to determine if there is a relationship between male students’ perceptions of their masculinity, academic motivation, and success at a specific higher education institution. Social role theory, personal construct theory, and self-determination theory served as the conceptual framework to understand if male students’ perceptions of their masculinity influence their higher education decisions and success. A mixed-methods, simultaneous explanatory methodology was utilized to attempt to discover possible links to male students’ academic success. During the Spring 2020 semester, 76 male full-time undergraduate students at a southeastern U.S. university with a relatively lower male student graduation rate responded to an anonymous questionnaire. Findings identified two primary factors that previous researchers suspected may be influencing the educational experience of male students. First, male students who see themselves as traditionally masculine or experience pressure to conform to traditional masculinity ideology are less likely to experience academic success. Second, amotivation is a key influencer of academic success among male undergraduate students. Discoveries such as those found in this study inform and influence higher education leaders, who should consider the contributing factors for declining success of all students and provide interventions and programs. Higher education personnel should assist male students with convolving the conflicting influences surrounding their masculinity and promote the lifelong benefits associated with academic success. Future studies should expand the institutions sampled in the study to determine if geography influences masculinity perceptions and attempt to focus on which aspects of traditional masculinity ideology are most predominate and contributory.
  • Georgia Rural District Leaders’ Experiences with the Strategic Waiver School System Flexibility Options: A Multi-Site Case Study

    Jenkins, Cheryl Lynn; Tift College of Education
    As part of the reform efforts of the Elementary and Secondary Education Act, flexibility waivers are allowed to enable local school leaders to create an environment tailored to unique school community needs. The purpose of this qualitative, multi-site case study was to chronicle and analyze the implementation of the Strategic Waiver School System (SWSS) flexibility option offered to Georgia school districts. Guiding this investigation were the theoretical framework of change theory, undergirded by an accountability framework for analyzing education reform. The main research question asked: How do successful school districts implement the SWSS flexibility option? Four ancillary questions that examined the school districts’ implementation in terms of commitment, coherency, congruence, and continuity also guided the study. The researcher sought to understand and describe school leaders’ perceptions regarding their experiences with implementing the strategic waiver initiative in selected Georgia school districts. The research participants were district level leaders from four small rural school districts. This research study implemented a qualitative method, which provided the flexibility to investigate this phenomenon in depth. This approach allowed the researcher the opportunity to capture the participants’ feelings and lived experiences with this new initiative. Use of content analysis and Nvivo 12 software of interviews, survey, and documents revealed five thematic codes. District leaders perceived that the initiative had allowed them the autonomy and flexibility necessary to improve educational outcomes for all students. Implications were to provide professional learning opportunities to address the limited knowledge of SWSS waivers held by district leaders and the creation of a monitoring system to track waiver usage and share ideas. Recommendations for future research included targeting suburban district leaders’ perspectives and conducting of a quantitative survey to gather perspectives or rate customer satisfaction.
  • Manager in the Middle: A View of Strategic Planning in Higher Education from the Middle Management Perspective

    Flanders, Kimberly Sharron; Tift College of Education
    Strategic planning is a process that can assist institutions in responding to and preparing for the myriad changes in higher education; however, a lack of communication and other challenges can hinder institutions’ ability to effectively engage in the process. Because middle managers serve as liaisons between organizational leadership and front-line staff, this transcendental phenomenological investigation sought to understand the experiences of middle managers in the strategic planning process through the lens of path-goal theory. Criterion and snowball sampling were used to identify twelve middle managers to participate in semi-structured, topical interviews. The data were analyzed utilizing the modified Van Kaam method of analysis of phenomenological data to develop a description of the phenomenon. Findings from this investigation indicated that middle managers experienced strategic planning as a top-down process implemented with a team approach and the goal of benefiting students and the institution. The participants shared that they would like to be included in strategic planning discussions early in the process to help shape institutional priorities and actions based on their experiences with students, parents, and other stakeholders. Additionally, the participants agreed that their teams should be included in the strategic planning process to garner more buy-in and to provide a robust breadth of knowledge and experience in the discussions. The middle managers in this study also noted that the attitude of the leadership and support from an institutional research, or similar, office impacted their experience with the strategic planning process. Strategic planning leaders can utilize the information gleaned from this study to more effectively engage middle managers in the process, such as by providing trainings and early involvement. Future research in this area should study middle managers working at different types of institutions and should include more faculty participants.

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