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Clinical Trials: Infectious Disease/Immune System (HIV/AIDS, Hepatitis)
IRB No. 99-226-1 (Dr. Juan Salazar, PI): Cutanenous Immune Response in Secondary Syphilis and Lyme Disease
This study involved three separate sub-studies: 1) Lipopeptide injection: this component of the study demonstrated the contribution of synthetic lipopeptides in triggering the immune response in humans, these synthetic lipopeptides mimic spirochetal lipoproteins; 2) Secondary syphilis patients: this component of the study was conducted in order to better understand the pathogenesis of early syphilis and to determine how syphilis can set the stage for acquiring and transmitting HIV; 3) Healthy volunteer blood draw: These experiments are primarily conducted to study the effects of two spirochetes (Borrelia burgdorferi and Treponema pallidum). The only portion of the study that remains open is the healthy blood draw; the international and national sites have finalized their recruitment and no patients are being followed, data from these patients is currently under data analysis.
IRB No. 12-188-2 (Dr. George Kuchel, PI): Impact of Aging T Cell Responses to Influenza Vaccination
Participate in our research study on the immune system looking at how we can use vaccines to protect us against infections. With aging, that system does not function as well. We think this research will provide information that could eventually lead to more effective vaccines for preventing influenza illness and potentially other infectious diseases in older people. Men and Women must be 20-30 years old OR 50 years of age and Older; Have been vaccinated in last year, but not for current flu season; Do not have any Immunosuppressive diseases or on any Immunosuppressive therapy. Participants must be willing to come in for 4 study visits where blood will be drawn at 3 visits. Standard Flu vaccinations will be given as part of the study at no charge. Monetary compensation will be provided.
IRB No. 14-017-2 (Dr. Arvind Chhabra, PI): Generation of Customized Anti-Tumor T Cells From Human Pluripotent Stem Cells (hPS) Derived Embryoid Bodies (EB) For Immunotherapy of Human Melanoma.
Our study aims to combine the self-renewable potential of human pluripotent stem cells (hPS) with the TCR engineering technology to create a large reservoir of patient specific, immunologically matched, customized anti-tumor T cells with defined functional characteristics. The central hypothesis driving our study is that “the hPS derived EB can be utilized as an efficient model to study the differentiation of HSC precursors into T cells, in situ. Understanding the molecular mechanism of in-situ T cell generation in EB, in combination with the TCR engineering approach, could be utilized to generate naive, patient specific, customized anti-tumor T cells, for an effective cancer immunotherapy”.
IRB No. 14-162-2 (Dr. Patricia Diaz, PI): The prevalence of culturable and non-culturable fungi among patients with cancer undergoing chemotherapy treatment alone or in combination with head neck radiotherapy and non-cancer controls
To conduct a pilot comparison of the prevalence and abundance of culturable and non-culturable fungi among individuals diagnosed with cancer (during the course of chemotherapy alone or combined with head and neck radiation therapy) and non-cancer subjects.
IRB No. 15-006-3 (Dr. George Kuchel, PI): Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
This is a 5-year randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a U.S. approved high-dose influenza vaccine in older people. Trial Objectives The strategic objectives of this proposal are to conduct a randomized study of the U.S. approved SD-SVV vs. HD-SVV to establish GrzB activity and the IFN :IL-10 ratio in influenza-stimulated PBMC as biomarkers of clinical protection against the serious complications of influenza infection; develop a clinical tool (frailty index) and biomarkers (CMV status and bGrzB activity) for use in point-of-care testing to predict the response to influenza vaccination and appropriately target other prevention strategies to reduce the impact of influenza illness in particularly vulnerable older people; and translate these findings to testing new vaccines for their potential to significantly enhance protection against the serious complications of influenza in older adults. In the process, we will determine whether the Frailty Index [31], as a predictor of functional decline and mortality [32], can be used as point-of-care testing in the management of influenza. Table 1 summarizes the 5-year plan. The experimental design incorporates extensive experience in measuring T-cell responses to influenza vaccination and a study design that reflects an understanding of the variables that contribute to the heterogeneity of health and frailty in older adults. The overall experimental plan is described in three sections including a) Study Populations, b) Experimental Design including the Overall study protocol and Specific Aims 1-3), and c) Tests and Assays. Study Hypothesis (Aim 1) Determine whether a high dose vaccine performs better than standard doses Study Hypothesis (Aim 2): Evaluate the association of degree of frailty to cytomegalovirus (CMV) status and bGrzB levels in resting T cells. Study Hypothesis (Aim 3): Establish predictors of vaccine-mediated protection that can be developed for point-of-care testing
IRB No. 15-102-3 (Dr. Santhanan Lakshminarayanan, PI): A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the safety, tolerability and effectiveness of a new investigational drug (BMS-931699) that is being studied in male and female patients with Active Systemic Lupus Erythematosus (SLE).
IRB No. 16-164J-3 (Dr. George Kuchel, PI): Combination Adjuvants to Activate Human Dendritic Cell Subsets and B Cells
Vaccination is the most effective method for preventing infectious diseases. Many current vaccines are "inactivated" or "subunit" vaccines composed of purified or recombinant pathogen components to which an adjuvant is often added to increase the magnitude of antibody responses. However, subunit vaccines formulated with current FDA-approved adjuvants do not sufficiently boost immunity in some populations, particularly immunocompromised and elderly subjects. Numerous adjuvants have been discovered in recent years and show enhanced immunogenicity as single agents; however, little is known about the activity of their combination, their safety, their efficacy and their mechanisms of action. Responses to vaccination and adjuvants involve dendritic cells (DCs), which capture and present vaccine antigens thereby facilitating the differentiation of follicular helper T cells (Tfh) and B cells and subsequent humoral immunity Therefore, we will examine the molecular mechanisms and functional outputs of human DC subsets exposed to combination adjuvants ex vivo and in vivo (humanized mouse models). The focus on human DCs is essential given the substantial differences in innate immune receptor distribution and function between the mouse and the human. Healthy human subjects will be recruited to provide blood, waste skin or blood and waste skin from planned plastic surgical procedures along with skin specimens acquired from the UConn Health Research Biorepository to provide the human dendritic cells required for this research. Our goal is to select a combination adjuvant using functional assays, followed by in-depth investigation of molecular pathways accounting for enhanced immunogenicity. Our Specific Aims are built towards this goal. Specific Aims Aim 1: We will screen adjuvant combinations by assessing the capacity of adjuvant-activated human DC subsets to skew the differentiation of naive CD4+T cells into Tfh cells that secrete IL-21 and induce B cells to produce IgG and IgA antibodies. Aim 2: Promising combinations will be further studied in DCs using validated, sensitive and high-throughput transcriptomic epigenomic, proteomic and metabolomic methods, and by functional knockdown in vitro, to determine the underlying molecular pathways of adjuvant efficacy. Aim 3: We will then validate the identified molecular pathways through functional knockdown studies in vivo using humanized mice carrying a functionally reconstituted human immune system, which will also enable the examination of possible side effects This research program will leverage cutting-edge epigenetic (ATAC-seq), transcriptional, gene editing (CRISPR/Cas9) and metabolomic technologies; innovative humanized mouse models; a powerful computational and bioinformatics infrastructure at The Jackson Laboratory. Our deliverable is a combination adjuvant for enhanced humoral immunity and molecular pathways that are essential for its efficacy.