DR59 DataRelease
Release Date: December 2025
New Studies: 29
Updated Studies: 26
New Studies
| SDY2942: Intravenous BCG vaccination induces recruitment of Granzyme B+ Natural Killer cells to the lungs which is associated with protection against Mycobacterium tuberculosis in rhesus macaques | |||||||
| Status: | New | ||||||
| Description: | Intravenous (IV) vaccination with Bacillus Calmette-Guerin (BCG) mediates sterilizing immunity against Mycobacterium tuberculosis (Mtb) in rhesus macaques, and NK cells have been identified as an immune correlate of vaccine-induced protection. We used mass cytometry (CyTOF) to broadly profile pulmonary immunity induced by IV BCG and observed an expansion of CD69- NK cells characterized by higher expression of the cytotoxic molecule granzyme B in bronchoalveolar lavage. Flow cytometry experiments revealed that CD69- NK cells are induced by IV BCG, recruited to the lungs, and associated with protection against Mtb challenge. scRNA-Seq revealed durable changes in NK cell gene expression programs up to six months post-vaccination. Finally, an in vitro cytotoxicity assay revealed superior cytolytic capacity of CD69- NK cells compared to CD69+ NK cells derived from the lungs of IV-BCG vaccinated macaques. Taken together, our data suggest that IV-BCG induces the recruitment of CD69-granzyme B+ NK cells to the lungs where they may contribute to protection via direct lysis of Mtb-infected cells. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3256: ImmVar | ||||||||||
| Status: | New | |||||||||
| Description: | The goal of this study is to investigate factors that contribute to human immune variation. Prior studies have identified genetic, infectious, and biological associations with immune system competence and disease severity however, there have been few integrative analyses of these factors and study populations are often limited in demographic diversity (age, geography, ancestry, etc.). While still informative, it is impossible to ascertain the scope of immune variation in the human population when studies are focused on only specific subsets of the human population and limited observed factors to analyze. In this study, we quantify the contribution of intrinsic and extrinsic host factors on the setpoint of baseline (un-infected) immunity, and the magnitude and quality of the immune response to influenza infection in diverse populations from around the world. This project includes samples from 1,705 healthy or influenza infected subjects from 5 countries and 8 distinct populations. North American populations include the Memphis cohort and the Baltimore cohort. Latin American populations include the Nicaragua cohort and the Colombia cohorts, which include subjects from the local city of Calabazo and two indigenous populations, Seywiaka and Umandita. Samples also include a European cohort from Belgium and an Asian cohort from Taiwan. Putative determinants of immunity include: age, gender, genetics (as ancestry informative markers and immune related single nucleotide polymorphisms), race/ethnicity, and prior infectious exposures (herpesviruses). Measures of the immune system include characterization of immune cells, their functional responses, and immune products that mediate responses to infection. For influenza infected subjects, outcome measures include presence/absence of symptoms, symptom severity scores, amount of virus present in a patient, and duration of influenza virus production. To explain variation in these measures, regression modeling was utilized, which allows for an easily interpretable and transparent integrative analysis of all independent variables and a quantification of their unique, interactive, and collective effects on the immune measure of interest. | |||||||||
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| DOI: | None | |||||||||
| Subjects: | 0 | |||||||||
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| Publications: | None | |||||||||
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
| SDY3265: Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis (ACCESS) (ITN034AI) | ||||||||||||||||
| Status: | New | |||||||||||||||
| Description: | The ACCESS study (ITN034AI) is a multicenter, randomized, double-blind, controlled Phase II trial investigating whether the addition of abatacept to the Euro-lupus regimen can improve outcomes for adults with biopsy-confirmed lupus nephritis. Participants are assigned to receive either abatacept or placebo infusions, administered intravenously at weight-based doses, alongside cyclophosphamide given every two weeks for three months, followed by daily oral azathioprine for at least sixteen weeks. All subjects follow a standardized prednisone taper, beginning at a high dose and gradually reduced over twelve weeks. The protocol requires regular clinical assessments and laboratory monitoring, with a total of eighteen study visits in the first year and a final follow-up at two years. Therapy is adjusted according to individual response after the initial treatment phase: complete responders discontinue abatacept (or placebo) and continue azathioprine, while partial responders maintain both agents for an extended period. Non-responders may be withdrawn unless continued participation is justified and approved by protocol leadership. The study aims to enroll 134 participants over nearly four years, with each participant followed for two years, providing a robust framework to assess both short- and long-term safety and efficacy of abatacept as an adjunct to standard Euro-lupus therapy in lupus nephritis. | |||||||||||||||
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| DOI: | None | |||||||||||||||
| Subjects: | 137 | |||||||||||||||
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| Assays: | None | |||||||||||||||
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| SDY3271: Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant (A-WISH) (ITN030ST) | ||||||||||
| Status: | New | |||||||||
| Description: | The AWISH study is a multicenter, open-label Phase II clinical trial designed to evaluate the safety and feasibility of immunosuppression withdrawal in adult liver transplant recipients. The study population includes individuals with liver failure resulting from chronic hepatitis C infection as well as those with nonimmune, nonviral etiologies. After transplantation, all participants receive a standardized immunosuppressive regimen consisting of a calcineurin inhibitor and corticosteroids, with corticosteroids tapered over the initial three months. Throughout the first-year post-transplant, subjects undergo regular clinical and laboratory assessments, including protocol-mandated biopsies, to monitor graft function and detect any evidence of rejection. Eligibility for randomization is determined by stable monotherapy, preserved hepatic and renal function, absence of advanced fibrosis, and no recent histological signs of rejection. At one-year post-transplant, eligible subjects are randomized in a 4:1 ratio to either a structured immunosuppression withdrawal protocol or continued maintenance therapy. The withdrawal arm follows a carefully scheduled tapering algorithm, reducing immunosuppressive dosing in eight incremental steps over approximately twelve months. Both groups continue to be closely monitored for clinical status, laboratory parameters, and histopathological changes. The study aims to determine whether early minimization or cessation of immunosuppression can be achieved safely, and to characterize the clinical course, risks, and potential benefits of this approach in liver transplant recipients. Insights from AWISH are expected to inform future strategies for individualized immunosuppressive management and improve long-term outcomes for transplant patients. | |||||||||
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| DOI: | None | |||||||||
| Subjects: | 95 | |||||||||
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
| SDY3285: A Cooperative Clinical Study of Abatacept in Multiple Sclerosis (ACCLAIM) (ITN035AI) | |||||||||||||
| Status: | New | ||||||||||||
| Description: | Multiple sclerosis (MS) is a chronic, immune-mediated neuroinflammatory disorder characterized by autoreactive lymphocytes targeting myelin, resulting in demyelination and progressive neurological dysfunction. While several immunomodulatory and immunosuppressive therapies are available, their efficacy varies and systemic immunosuppression can lead to significant adverse effects. Abatacept (CTLA4-Ig) is a recombinant fusion protein that selectively modulates T cell activation by inhibiting the CD28-B7 costimulatory pathway. Although abatacept is approved for rheumatoid arthritis, its therapeutic potential in MS remains investigational. The ACCLAIM study is a multicenter, phase II, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and potential efficacy of abatacept in adults with relapsing-remitting multiple sclerosis (RRMS). Eligible participants are randomized to receive weight-adjusted intravenous infusions of abatacept or placebo over a 24-week core phase, followed by a crossover extension phase. All participants have the opportunity to receive both study drug and placebo, contingent on continued eligibility. Throughout the study, participants undergo regular clinical assessments, including neurological examinations, laboratory testing, and standardized motor function evaluations. Serial magnetic resonance imaging (MRI) is performed to monitor disease activity and radiographic changes. Safety is rigorously monitored via adverse event reporting and independent review. The ACCLAIM trial is conducted in accordance with international standards for clinical research and ethical oversight. Study medication and all protocol-related procedures are provided at no cost to participants. | ||||||||||||
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| DOI: | None | ||||||||||||
| Subjects: | 65 | ||||||||||||
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| Assays: | None | ||||||||||||
| Clinical Assessments: | None | ||||||||||||
| SDY3294: Development of an RT-qPCR and a Next Generation Sequencing approach to assess viral shedding of NDV-based SARS-CoV-2 variant vaccines | ||||||||||
| Status: | New | |||||||||
| Description: | The authors developed two methods to quantitatively evaluate NDV-HXP-S in vitro and in vivo and to quantify the different relative percentage of each NDV-HXP-S vaccine in a multivalent formulation. | |||||||||
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| DOI: | None | |||||||||
| Subjects: | 0 | |||||||||
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| Publications: | None | |||||||||
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
| SDY3303: Influenza T cell response post-vaccination | |||||||
| Status: | New | ||||||
| Description: | To understand and identify changes in the profile of influenza strain-specific T cells from days 3 to 28 post immnunization with Fluzone. The strain-specific correlations of cellular immnunity to influenza with plasma analytes and serological immnunity were also analyzed. Quantification and phenotyping of influenza strain-specific T cells were performed, as well as plasma analyte profiling by Luminex. | ||||||
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| DOI: | None | ||||||
| Subjects: | 37 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY3305: Stabilized dengue virus 2 envelope subunit vaccine redirects the neutralizing antibody response to all E-domains | ||||||||||||||||
| Status: | New | |||||||||||||||
| Description: | The four-dengue virus (DENV) serotypes cause several hundred million infections annually. Several live-attenuated tetravalent dengue vaccines (LAVs) are at different stages of clinical testing and regulatory approval. A major hurdle faced by the two leading LAVs is uneven replication of vaccine serotypes stimulating a dominant response to one serotype at the expense of the other three, leading to the potential for vaccine antibody (Ab) enhanced more severe infections by wild type DENV serotypes that fail to replicate in the vaccine. Protein subunit vaccines are a promising alternative since antigen dosing can be precisely controlled. However, DENV envelope (E) protein subunit vaccines have not performed well to date, possibly due to differences between the monomeric structure of soluble E and the E homodimer of the viral surface. Previously, we have combined structure-guided computational and experimental approaches to design and produce DENV2 E antigens that are stable homodimers at 37°C and stimulate higher levels of neutralizing Abs (NAbs) than the WT E antigen in mice. The goal of this study was to evaluate if DENV2 E homodimers stimulate NAbs that target different epitopes on E protein compared to the WT E monomer. Using DENV4/2 chimeric viruses and Ab depletion methods, we mapped the WT E-elicited NAbs to simple epitopes on domain III of E. In contrast, the stable E homodimer stimulated a more complex response towards all three surface-exposed domains of the E protein. Our findings highlight the impact of DENV2 E oligomeric state on the quality and specificity of DENV NAbs, and the promise of DENV E homodimers as subunit vaccines. | |||||||||||||||
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| DOI: | None | |||||||||||||||
| Subjects: | 40 | |||||||||||||||
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| Clinical Assessments: | None | |||||||||||||||
| SDY3309: Multivalent administration of dengue E dimers on liposomes elicits type-specific neutralizing responses without immune interference | ||||||||||||||||
| Status: | New | |||||||||||||||
| Description: | The four serotypes of dengue virus (DENV1-4) are a major health concern putting 50% of the global population at risk of infection. Crucially, DENV vaccines must be tetravalent to provide protection against all four serotypes because immunity to only one serotype can enhance infections caused by heterologous serotypes. Uneven replication of live-attenuated viruses in tetravalent vaccines can lead to disease enhancement instead of protection. Subunit vaccines are a promising alternative as the vaccine components are not dependent on viral replication and antigen doses can be controlled to achieve a balanced response. Here, we show that a tetravalent subunit vaccine of dengue envelope (E) proteins computationally stabilized to form native-like dimers elicits type-specific neutralizing antibodies in mice against all four serotypes. The immune response was enhanced by displaying the E dimers on liposomes embedded with adjuvant, and no interference was detected between the four components. | |||||||||||||||
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| DOI: | None | |||||||||||||||
| Subjects: | 72 | |||||||||||||||
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| Clinical Assessments: | None | |||||||||||||||
| SDY3311: Afucosylation of Anti-Dengue IgG is Associated with Enhanced Susceptibility to Dengue Virus Infection Post-Vaccination (Murine data) | |||||||||||||
| Status: | New | ||||||||||||
| Description: | Dengue viruses (DENV) cause 390 million infections annually, though only approximately 25% of these infections are symptomatic. Whereas antibody features linked to severe DENV disease are well studied, factors influencing infection susceptibility remain less clear. Here, we examined IgG characteristics before and after DENV vaccination (Dengvaxia) in individuals with a history of prior DENV exposure, comparing those who developed post-vaccination infections to those who remained infection-free. Elevated anti-DENV afucosylation, present before or after vaccination, was associated with increased likelihood of infection after vaccination. These data were further supported by mechanistic studies, which revealed that non-neutralizing, afucosylated, post-Dengvaxia IgG enhanced DENV replication in mice. This enhancement was dependent on CD16, the receptor for the afucosylated IgG Fc domain. Together, these findings support a model in which the presence of afucosylated IgG promotes virus replication, increasing the likelihood of productive infection upon DENV exposure. Moreover, these results highlight that IgG1 fucosylation is a highly specific predictor of risk for breakthrough DENV infection despite vaccination and support the importance of investigating strategies to regulate Fc fucosylation during vaccination. | ||||||||||||
| Program/Contract: |
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| DOI: | None | ||||||||||||
| Subjects: | 64 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY3312: Afucosylation of Anti-Dengue IgG is Associated with Enhanced Susceptibility to Dengue Virus Infection Post-Vaccination | |||||||||||||
| Status: | New | ||||||||||||
| Description: | Dengue viruses (DENV) cause 390 million infections annually, though only approximately 25% of these infections are symptomatic. Whereas antibody features linked to severe DENV disease are well studied, factors influencing infection susceptibility remain less clear. Here, we examined IgG characteristics before and after DENV vaccination (Dengvaxia) in individuals with a history of prior DENV exposure, comparing those who developed post-vaccination infections to those who remained infection-free. Elevated anti-DENV afucosylation, present before or after vaccination, was associated with increased likelihood of infection after vaccination. These data were further supported by mechanistic studies, which revealed that non-neutralizing, afucosylated, post-Dengvaxia IgG enhanced DENV replication in mice. (Murine data is included in a separate deposition.) This enhancement was dependent on CD16, the receptor for the afucosylated IgG Fc domain. Together, these findings support a model in which the presence of afucosylated IgG promotes virus replication, increasing the likelihood of productive infection upon DENV exposure. Moreover, these results highlight that IgG1 fucosylation is a highly specific predictor of risk for breakthrough DENV infection despite vaccination and support the importance of investigating strategies to regulate Fc fucosylation during vaccination. | ||||||||||||
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| DOI: | None | ||||||||||||
| Subjects: | 88 | ||||||||||||
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| SDY3313: SARS-CoV-2 neutralising antibodies after a second BA.5 bivalent booster | |||||||
| Status: | New | ||||||
| Description: | The authors assessed serum SARS-CoV-2-neutralising titres in 70 longitudinal samples from 18 immunocompetent individuals after multiple mRNA vaccine doses to track antibody dynamics over time. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3314: From first infection to reinfection: Comparing Nucleocapsid antibody kinetics in vaccinated and unvaccinated adults | |||||||
| Status: | New | ||||||
| Description: | The authors analyze NP-antibody dynamics considering individual vaccination status and prior infections to better understand the NP-antibody response to infection in vaccinated and unvaccinated individuals. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3315: Characterization of the glycoproteins of fish and amphibian influenza B-like viruses | ||||||||||
| Status: | New | |||||||||
| Description: | Here, the authors report the functional, antigenic, and structural characterization of the SILV, SAEILV, and CSILV glycoproteins. | |||||||||
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| DOI: | None | |||||||||
| Subjects: | 0 | |||||||||
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
| SDY3316: Structural basis of broad protection against influenza virus by human antibodies targeting the neuraminidase active site via a recurring motif in CDR H3 | |||||||
| Status: | New | ||||||
| Description: | The authors describe cryo-electron microscopy structures of the broadly protective human antibody DA03E17 | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3317: A live attenuated NS1-deficient vaccine candidate for cattle-origin influenza A (H5N1) clade 2.3.4.4.b viruses | |||||||
| Status: | New | ||||||
| Description: | The authors developed a nonstructural protein 1 (NS1)-deficient mutant of a low pathogenic version of the cattle-origin human influenza A/Texas/37/2024 H5N1, namely LPhTXdNS1, and here, assess its safety, immunogenciity and protective efficacy. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3319: Chimeric hemagglutinin split vaccines elicit broadly cross-reactive antibodies and protection against group 2 influenza viruses in mice | |||||||
| Status: | New | ||||||
| Description: | The authors developed group 2 cHA vaccine candidates: cH15/3HK14N2HK14 and cH4/3HK14N2HK14. They have tested them as LAIVs, inactivated split vaccines, and combinations of these two platforms in the mouse model. | ||||||
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| DOI: | None | ||||||
| Subjects: | 93 | ||||||
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| SDY3320: Humoral Correlates of Protection Against Influenza A/H3N2 Virus Infection | ||||||||||
| Status: | New | |||||||||
| Description: | The investigators aimed to explore the humoral correlates of protection against influenza A/H3N2 virus infection with a particular emphasis on the role of the HA stalk as an independent correlate of protection against A/H3N2 virus infection | |||||||||
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| DOI: | None | |||||||||
| Subjects: | 0 | |||||||||
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| Assays: | None | |||||||||
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| SDY3321: M7 adjuvanted COBRA HA Influenza Vaccines | |||||||
| Status: | New | ||||||
| Description: | Development of next-generation influenza vaccine using the Computationally Optimized Broadly Reactive Antigen (COBRA) methodology. Mice were intranasally vaccinated with Mastoparan 7 adjuvanted COBRA (H1/H3) vaccine. Samples from animals were collected for immune response assessment via HAI, ELISA and viral titer. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3325: Characterization of the SARS-CoV-2 BA.5.5 and BQ.1.1 Omicron variants in mice and hamsters | |||||||
| Status: | New | ||||||
| Description: | Here, the investigators tested a SARS-CoV-2 Omicron lineage variant, BQ.1.1, in multiple rodent models. | ||||||
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| DOI: | None | ||||||
| Subjects: | 137 | ||||||
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| SDY3331: Several vaccinations with influenza hemagglutinin expands human antibody responses to unmatched flu viruses | |||||||
| Status: | New | ||||||
| Description: | The evaluation of longitudinal influenza vaccine adminstration of H1N1 2009 enhanced receptor-blocking antibodies to highly unmatched H1N1 strains. The repeated exposure to the immunogen can broaden the antibody response against the diversified virus targets. | ||||||
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| DOI: | None | ||||||
| Subjects: | 27 | ||||||
| Study PI, contact: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3333: A human 3D culture-organ-on-chip platform for investigating the tumor microenvironment response to ionizing radiation | |||||||
| Status: | New | ||||||
| Description: | Studying complex human responses, such as radiation-induced effects in the tumor microenvironment (TME), requires advanced in vitro systems. Here, we present the Apparatus to Simulate Tumor and Reproduce Organs in an Interactive and Dynamic System (ASTEROIDS), which integrates three-dimensional cell culture with organ-on-chip technology. To characterize the ASTEROIDS, a lung TME was reproduced by co-culturing cancer spheroids with endothelial and fibroblast cells mimicking vascular and stromal compartments. The ASTEROIDS maintained cell viability, endothelial barrier formation, and spheroid zonal structure for seven days. Transcriptomic profiling revealed endothelial-tumor crosstalk, while perfused immune cells exhibited recruitment and immunoregulatory activation. Upon stereotactic-dose irradiation, ASTEROIDS showed dose-dependent DNA damage, nuclear hypertrophy, endothelial barrier disruption, spheroid growth inhibition and metabolomic alterations. Together, these results demonstrate that ASTEROIDS faithfully reproduces TME-level organization and responses, establishing its feasibility as a pre-clinical human model for studying radiation effects and tumor-immune interactions. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Publications: | None | ||||||
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| SDY3334: JAX CCHI-Host-specific effects on bacterial modulation of respiratory epithelial gene expression and alternative splicing | ||||||||||
| Status: | New | |||||||||
| Description: | Given the extensive variability inherent to humans and how variable microbiome composition is between individuals, we wanted to investigate inter-individual differences in host response to microbial colonization. Using primary normal human bronchial epithelial cells from six different adult donors (including both males and females and spanning in age from mid-20s to mid-50s), we cultivated air-liquid interface tissue cultures (ALI) from each donor. ALIs are pseudostratified cell cultures where the epithelial cells have differentiated into the appropriate subtypes (goblet cells, ciliated cells, club cells, etc). We colonized the ALI with one of three phylogenetically diverse microbes (Staphylococcus epidermidis, Rothia aeria, and Klebsiella aerogenes) for 12, 24, and 48 hours. At each time point, we sequenced the total RNA from the eukaryotic respiratory epithelial cells with the goal of identifying patterns of the gene expression change that were consistent or variable across the donors and evaluate if these patterns were dependent on the colonizing microbe. | |||||||||
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| DOI: | None | |||||||||
| Subjects: | 6 | |||||||||
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| Publications: | None | |||||||||
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| SDY3348: Assessment of critical bioprocess parameters for broadly cross-reactive chimeric hemagglutinin influenza virus vaccines | |||||||
| Status: | New | ||||||
| Description: | In this study, the authors detail a modified and optimized laboratory-scale egg bioprocess for cHA vaccine production with special focus on group 2 cHA viruses that grow to moderate titers. | ||||||
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
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| Assays: | None | ||||||
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| SDY3349: COBRA HA and NA Influenza Vaccines Adjuvanted with CpG | |||||||
| Status: | New | ||||||
| Description: | In this study, mice with pre-existing immunity to influenza or immunologically naive mice were vaccinated intramuscularly or intranasally with COBRA rHA and rNA proteins, Y2, NG2, N1, and N2 (COBRA HA/NA), and adjuvanted with CpG 1018. As controls, some mice were vaccinated with COBRA HA/NA vaccines without adjuvant, mock vaccinated, or vaccinated with CpG 1018 alone. Animals were challenged intranasally with the H1N1 strain, A/Brisbane/02/2018, and observed for 14 days post-infection. Serum, lung, spleen, and BALF were collected at different timepoints for immune response assessments measured through assays including HAI, ELISA, ELLA, Fluorospot, and Plaque Assay. | ||||||
| Program/Contract: |
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3354: Antibody Sequencing and Profiling of the Human HA-specific Memory B Cell Response After Vaccination | |||||||
| Status: | New | ||||||
| Description: | In the study, human subjects received doses of seasonal inactivated influenza vaccine (IIV). Blood samples were collected on days 0, 7, and 21 to gather serum and peripheral blood mononuclear cells (PBMCs). The serum samples underwent ELISA and hemagglutination inhibition (HAI) assays using a variety of historical and recent recombinant hemagglutinin (rHA) protein strains and influenza viruses. This was done to evaluate the breadth of immune response and HAI at the polyclonal level in the participants. The PBMC samples were stimulated and used to assess the magnitude and frequency of antibodies. D21 samples were processed through FACS to sort HA-specific B memory cells and single-cell (sc) sequence their antibody repertoire by NGS. Selected antibodies were cloned, produced, and tested for binding and functional studies. | ||||||
| Program/Contract: |
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3355: Analysis of cellular immune responses to Influenza vaccines | ||||||||||
| Status: | New | |||||||||
| Description: | Participants aged 28 to 60 and 65 to 85 received one of four influenza vaccines, Fluzone Standard-Dose (FSD), Flucelvax (FCEL), Fluzone High-Dose (FHD), or Fluad (FAD) during the 2023/2024 influenza season. Blood samples were collected both before and after vaccination to assess immune responses. The analysis focused on hemagglutination inhibition activity, antibody-secreting cells, and HA-specific immune compartments, including memory B cells, circulating T follicular helper cells, and CD4 T effector cells. These evaluations provided insight into the immune mechanisms activated by different influenza vaccines across age groups. | |||||||||
| Program/Contract: |
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| DOI: | None | |||||||||
| Subjects: | 0 | |||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
| SDY3356: Lipid nanoparticle composition for adjuvant formulation modulates disease after influenza virus infection in quadrivalent influenza vaccine vaccinated mice. | |||||||
| Status: | New | ||||||
| Description: | The investigators test influenza vaccination in a mouse model with two adjuvants: Sendai virus-derived defective interfering (SDI) RNA, a RIG-I agonist; and an amphiphilic imidazoquinoline (IMDQ-PEG-Chol), a TLR7/8 agonist. | ||||||
| Program/Contract: |
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| DOI: | None | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3357: T cells SARS-CoV-2 | |||||||
| Status: | New | ||||||
| Description: | SARS-CoV-2 infection in unvaccinated children and T cells | ||||||
| Program/Contract: |
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| DOI: | None | ||||||
| Subjects: | 100 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: |
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Updated Studies
| SDY2693: Immunity in presence of Retinol | |||||||
| Status: | Updated | ||||||
| Description: | Relationship between season, retinol, RBP, 25(OH)D levels, and antibody isotype levels in a childhood cohort | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3FBOTXJFZ | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY2745: Structural analysis of COBRA protection | |||||||
| Status: | Updated | ||||||
| Description: | Not Provided | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3DD8R6RI0 | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY2751: Multi-subtype protection N1 Vaccination | |||||||
| Status: | Updated | ||||||
| Description: | Protection induced by vaccination with the computationally optimized broadly reactive NA antigen (N1-I COBRA NA) was characterized in both influenza serologically naive and pre-immune ferret models following H1N1 viral challenge. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3QYG9MI3P | ||||||
| Subjects: | 195 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: |
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| SDY2839: Advax adjuvanted COBRA vaccines | |||||||
| Status: | Updated | ||||||
| Description: | Evaluate the immune response induced by Advax-SM adjuvant in combination with broadly reactive influenza hemagglutinin (HA) vaccines in mouse model and to investigate how these responses elicit the most protective immune responses against H1N1 and H3N2 influenza viruses. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3UD76FFV9 | ||||||
| Subjects: | 72 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: |
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| SDY2852: Metabolome baseline discriminates to the influenza vaccination | ||||||||||
| Status: | Updated | |||||||||
| Description: | Computational analysis of baseline metabolic differences were conducted to increase the response to inactivated fluzone vaccination in ferrets and humans. The demographic samples of the subjects were assessed and measured via seroconversion via HAI from plasma samples. Overall the metabolic profiles could separate the high-risk responders from the high-risk no-responders. | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3YJDHQZ3T | |||||||||
| Subjects: | 178 | |||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
| SDY2854: COBRA HA plus RDOTAP | |||||||
| Status: | Updated | ||||||
| Description: | Mice were vaccinated with COBRA HA plus RDOTAP and assessed for immune responses | ||||||
| Program/Contract: |
|
||||||
| DOI: | 10.21430/M3N6U92SLZ | ||||||
| Subjects: | 397 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY2863: Antigenicity and receptor affinity of SARS-CoV-2 BA.2.86 spike | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Status: | Updated | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Description: | Here, human sera and monoclonal antibodies were used to examine SARS-CoV-2 Omicron subvariant BA.2.86's antigenicity. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Program/Contract: |
|
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| DOI: | 10.21430/M3K2IUTNPS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Subjects: | 58 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: |
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| Clinical Assessments: |
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| SDY2932: Co-administration of seasonal quadrivalent influenza and COVID-19 vaccines leads to enhanced immune responses to influenza virus and reduced immune responses to SARS-CoV-2 in naive mice | ||||||||||
| Status: | Updated | |||||||||
| Description: | The authors assessed the protective efficacy and humoral immune responses elicited by concomitant administration of a QIV and the Pfizer-BioNTech mRNA COVID-19 vaccine in naive BALB/c mice. | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3DYPQ4GBE | |||||||||
| Subjects: | 0 | |||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
| SDY2965: Influenza Vaccination | |||||||
| Status: | Updated | ||||||
| Description: | In this study, we compared vaccine-induced humoral immune responses induced by seasonal influenza vaccination with inactived vaccine (IIV/Fluzone) and live attenuated mucosal vaccine (LAIV/FluMist) in humans. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3WBGCDKFD | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY2967: Zinc Carnosine Metal-Organic Coordination Polymer as a Potent Influenza Vaccine Platform | |||||||
| Status: | Updated | ||||||
| Description: | Evaluation of Zinc Carnosine Metal-Organic coordination polymer as a delivery vehicle for COBRA HA Y2 and the adjuvant CpG. Immunogenicity was assessed in vivo in mice vaccinated with Y2 and CpG complexed with ZnCar, demonstrating improved humoral and cellular responses compared to mice vaccinate with Y2 and CpG only. The ZnCar complex shows superiority in storage stability as well. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3THVHFSFN | ||||||
| Subjects: | 90 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: |
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||||||
| SDY2969: COBRA HA and NA vaccines and influenza immune response | |||||||
| Status: | Updated | ||||||
| Description: | Healthy mice were vaccinated with Z1, IAN8, Q6, N1-I, and N2-B COBRA vaccines formulated with Addavax, then challenged with A/Sichuan/26221/2014 virus. Serologic antibodies, protective efficacy and possible contribution of protection were investigated. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3YQNDWAWG | ||||||
| Subjects: | 57 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: |
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| SDY3016: Vaccination History, BMI, Age and Gene Expression Predict Influenza Vaccination Outcomes | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | A number of factors influence vaccination effectiveness, including age, sex, and comorbidities. A transcriptome analysis was performed via RNA sequencing. The genes with immunological functions are increased in expression in individuals with high pre-existing immunity. Based on the transcriptome analysis, the set of genes can be used to predict a vaccine response. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3KA9EZEP8 | ||||||||||||
| Subjects: | 275 | ||||||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||||||||
| Clinical Assessments: |
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| SDY3025: Obesity affects influenza disease severity and transmission in ferrets | |||||||||
| Status: | Updated | ||||||||
| Description: | Investigation of mechanisms of influenza disease severity and trasmission in the context of obesity. Diet-induced ferret were used to explore the impact of obesity on disease pathogenesis, viral transmission, and evolution. | ||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3RHS9QED5 | ||||||||
| Subjects: | 142 | ||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: |
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| Clinical Assessments: |
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| SDY3042: Single dose IIV vaccine expressing COBRA HA elicits broadly-reactive and long-lasting protection | |||||||
| Status: | Updated | ||||||
| Description: | To assess the COBRA-IIV vaccine effectiveness, pre-immune ferrets received either COBRA-WIV or COBRA-SIV vaccinations, followed by an H1N1 influenza virus challenge after 14 weeks. The evaluation involved measuring antibody titers with HAI, assessing protection against direct infection, and monitoring viral shedding and transmission prevention. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3Q2F40L9Z | ||||||
| Subjects: | 72 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: |
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| SDY3049: Antibody production using COBRA-IIV vaccine | |||||||
| Status: | Updated | ||||||
| Description: | Healthy mice were vaccinated with a formulated COBRA-IIV Y2 and J4 vaccines adjuvanted with AddaVax, then challenged with H1N1 BS/18 or H3N2 SW/13 viruses. Lung and sera samples were then collected to determine viral titer compared with a mock PBS vaccinated group. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M30FD1JQOC | ||||||
| Subjects: | 381 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: |
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| SDY3098: Induction of Antigen-Specific Tolerance in Multiple Sclerosis Model without Broad Immunosuppression | |||||||
| Status: | Updated | ||||||
| Description: | Microparticles made of acetalated dextran loaded with antigenic peptide and the tolerizing drug rapamycin (Rapa) were evaluated in an experimental autoimmune encephalomyelitis model induced by myelin oligodendrocyte glycoprotein (MOG) in both early and late therapeutic models to mimic different stages of Multiple Sclerosis. | ||||||
| Program/Contract: |
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||||||
| DOI: | 10.21430/m3hlev7yxj | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3119: Multivalent COBRA influenza vaccine elicits immune response in pre-immune ferrets | |||||||
| Status: | Updated | ||||||
| Description: | Investigation of the immune response and effectiveness of the next-generation hemagglutinin and neuraminidase proteins, designed using computationally optimized broadly reactive antigen (COBRA) methodology, in elderly ferrets. The animals were pre-immunized with Sing/86 and Pan/99 and prime-boost vaccinated with mixtures of COBRA-based influenza vaccines (J4, Y2, NG2, NG7, NG8, N1-I, and N2-B), and Infectimune adjuvant. The elderly ferrets were challenged with Tas/20; blood samples and nasal washes were collected for several analyses. | ||||||
| Program/Contract: |
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||||||
| DOI: | 10.21430/m3bra9cso9 | ||||||
| Subjects: | 36 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: |
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| SDY3164: Influenza vaccination response is associated with the DNA methylation of T cell pathways | |||||||
| Status: | Updated | ||||||
| Description: | Using multifactorial approach, the study explored the interaction between DNA methylation and the influenza vaccine response. Factors including age, BMI, and cell type proportions were evaluated, leading to the identification of key methylation sites associated with RIG-I signaling and genes involved in innate immunity ro viruses. The longitudinal study included a subset of 42 participants vaccinated with Fluzone, enrolled in UGA5 and had previously been part of the UGA4 season. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M38DJZGGZY | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3165: COBRA rHAs adjuvanted with Infectimune generate broadly protective antibody responses in animals | |||||||||||||||||||
| Status: | Updated | ||||||||||||||||||
| Description: | The goal of the study was to investigate whether the use of Infectimune combined with COBRA recombinant HA (rHA) proteins could increase the antibody response, compared to using the COBRA rHA alone, especially in mice with pre-existing influenza immunity. Animals were vaccinated with different doses of COBRA rHA to evalaute the dose-sparing effects of the adjuvant. COBRA rHA vaccines (with and without adjuvant) were also compared to vaccines using wild-type rHA proteins. Sera was collected from animals for serological assays, such as microneutralization, HAI and ELISA. Lung and nasal washes were colleted to determine the viral load by plaque assay. | ||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3G9COVSH1 | ||||||||||||||||||
| Subjects: | 73 | ||||||||||||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: |
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| Clinical Assessments: |
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| SDY3190: SAM COBRA vaccine antibody response to influenza | |||||||
| Status: | Updated | ||||||
| Description: | The use of self-amplifying mRNA (SAM) vaccines that express COBRA-HA proteins are used to create a more effective seasonal flu vaccine. Mice and ferrets were vaccinated with the SAM COBRA-HA vaccine, and sera samples were collected after. Hemagglutination assays (HAI) and viral plaque assays were used to evaluate antibody response to the virus. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3XNZULSWC | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3230: Protection against reinfection with Mycobacterium tuberculosis extends across heterologous Mtb lineages | |||||||
| Status: | Updated | ||||||
| Description: | Immunological memory elicited either through previous or ongoing M. tuberculosis (Mtb) infection provides a critical mechanism by which hosts protect against re-infection and disease progression upon Mtb re-exposure. Conversely, the global circulation of—and uneven competition between—distinct Mtb strains suggest certain bacterial clades are able to better spread across communities, potentially by evading memory responses gained by prior infection with genomically different strains. To address this question, we conducted a heterologous reinfection study in cynomolgus macaques involving primary infection by a Lineage 4 Erdman Mtb strain and subsequent re-infection by a Lineage 2 strain (L2-HT), which belongs to a clade that has been epidemiologically shown to be successfully spreading over the last decade in Lima, Peru cohort. Here, through microbiologic, PET-CT and sequencing of Mtb genomic barcodes, we show that reinfected animals developed fewer lung lesions and controlled both pulmonary and disseminated forms of disease better than naïve animals that have had no prior exposure to Mtb. Thus, protection against reinfection is not limited by Mtb lineage, providing optimism that vaccines can be effective across populations and geographic locations. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3UDKB7YI5 | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: | None | ||||||
| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3245: Determinants of health as predictors for differential antibody responses following SARS-CoV-2 primary and booster vaccination in an at-risk, longitudinal cohort | |||||||
| Status: | Updated | ||||||
| Description: | The authors study the effects of extrinsic and intrinsic health factors on the peak antibody response following COVID-19 primary vaccination and on the trajectory of peak antibody magnitude and durability over time. | ||||||
| Program/Contract: |
|
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| DOI: | 10.21430/M3W8JRYTMV | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3281: Predictors for reactogenicity and humoral immunity to SARS-CoV-2 following infection and mRNA vaccination: A regularized, mixed-effects modelling approach. | |||||||
| Status: | Updated | ||||||
| Description: | Linear mixed effects models were used to evaluate symptoms experienced by COVID-positive participants during natural infection and following SARS-CoV-2 mRNA vaccination | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3W2M30RIR | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3282: cGAMP Microparticles Affect the Immunogenicity of Influenza mRNA Vaccine | |||||||
| Status: | Updated | ||||||
| Description: | Evaluation of the immune response in mice by administering COBRA mRNA-LNPs and Polymeric cGAMP Microparticle vaccine formulations and measuring antibody production and protection against lethal influenza challenge. Additionally, in vitro assays were conducted to assess how the STING agonist affected mRNA translation. | ||||||
| Program/Contract: |
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||||||
| DOI: | 10.21430/M3Q3DP8MD4 | ||||||
| Subjects: | 0 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY3283: Neutralizing antibodies and IgG4 subclass switching following vaccination with Covid-19 mRNA vaccines does not reduce infections | ||||||||||
| Status: | Updated | |||||||||
| Description: | A longitudinal study comparing humoral immune responses in SARS-CoV-2 naive and previously infected individuals after a two-dose mRNA vaccine and booster. Anti-spike RBD IgG levels, neutralizing antibody titers against Wuhan-Hu-1 and Omicron BA.1, and IgG subclass distributions were measured over time. | |||||||||
| Program/Contract: |
|
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| DOI: | 10.21430/M3QE4VCMVY | |||||||||
| Subjects: | 0 | |||||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
| SDY3301: Proteomic signatures | |||||||
| Status: | Updated | ||||||
| Description: | Measuring proteomic signatures in UGA cohort 2019-2020 season | ||||||
| Program/Contract: |
|
||||||
| DOI: | 10.21430/M3JVF5RTPG | ||||||
| Subjects: | 151 | ||||||
| Study PI, contact: |
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| Publications: |
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| Resources: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||