DR6 DataRelease
Release Date: 12/01/2013
| SDY180: Systems scale interactive exploration reveals quantitative and qualitative differences in response to 2009-2010 Fluzone influenza vaccine and pneumococcal vaccine | |||||||||||||||||
| Status: | New | ||||||||||||||||
| Description: | Systems immunology approaches were employed to investigate innate and adaptive immune responses to influenza and pneumococcal vaccines. These two non-live vaccines show different magnitudes of transcriptional responses at different time points af- ter vaccination. Software solutions were developed to explore correlates of vaccine efficacy measured as antibody titers at day 28. These enabled a further dissection of transcriptional responses. Thus, the innate response, measured within hours in the peripheral blood, was dominated by an interferon transcriptional signature after influenza vaccination and by an inflammation signature after pneumo- coccal vaccination. Day 7 plasmablast responses induced by both vaccines was more pronounced after pneumococcal vaccination. Together, these results suggest that comparing global immune responses elicited by different vaccines will be critical to our understanding of the immune mechanisms underpinning successful vaccination. | ||||||||||||||||
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| DOI: | 10.21430/M3I44H8R17 | ||||||||||||||||
| Subjects: | 46 | ||||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||||
| SDY241: Simulation and Prediction of the Adaptive Immune Response and Quantification of Early and Adaptive Immune Response Kinetics to Influenza A Virus Infection | ||||||||||
| Status: | New | |||||||||
| Description: | Seasonal and pandemic influenza A virus (IAV) continues to be a public health threat. Modeling approaches were used combined with experimental data to investigate innate and adaptive immune responses to IAV infection. Mathematical models developed describe the dynamic interactions between influenza virus, target cells, cytotoxic lymphocytes, and virus-specific IgG and IgM. A two-compartment model developed quantifies the effects of viral replication and adaptive immunity. | |||||||||
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| DOI: | 10.21430/M3ERWHDJEO | |||||||||
| Subjects: | 494 | |||||||||
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| Clinical Assessments: | None | |||||||||
| SDY210: Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies | |||||||
| Status: | Updated | ||||||
| Description: | Over the past two decades, the prevalence of asthma has dramatically increased in many parts of the world. The current National Asthma Education and Prevention Program (NAEPP) identifies inhaled corticosteroids (ICS) as the preferred long-term control therapy for all forms of persistent asthma. However, there is still a significant proportion of patients with persistent asthma who are not receiving ICS therapy or do not follow their treatment plan. Individualized asthma treatment plans are needed. The use of biomarkers, in addition to NAEPP guidelines, may help enhance the level of asthma assessment, guide medication regimens, and improve overall asthma control. This study will determine whether NAEPP-recommended treatment, combined with eNO measurement, is more effective in reducing asthma symptoms than NAEPP-recommended treatment alone. ICAC-01 will last 46 weeks and will comprise 8 study visits. ICAC-01 also includes a mechanistic sub-study (ICAC-02). Its primary objective is to determine whether highly sensitized, compared to weakly sensitized asthmatic subjects have more severe asthma, as defined by the levels at randomization to the completion of ICAC-01. To address the primary objective of ICAC-02, the study will include all the participants enrolled in ICAC-01 with dust mite-, cockroach- and/or alternaria-specific IgE levels within certain parameters. | ||||||
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| DOI: | 10.21430/M3I0JL7KUZ | ||||||
| Subjects: | 546 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY211: Inner-City Anti-IgE Therapy for Asthma | |||||||
| Status: | Updated | ||||||
| Description: | This study is testing a medication called omalizumab for the treatment of asthma. Immunoglobulin E (IgE) is produced when one is exposed to allergens and it can cause inflammation in the lungs. Omalizumab can reduce inflammation and asthma attacks by blocking IgE. Unlike other medications for asthma, omalizumab is not an inhaler medication or pill. Instead, omalizumab is dissolved in a liquid and given by injection. Studies indicate that people living in the inner-city areas are more likely to be exposed to indoor allergens that are difficult to avoid than people living in other areas. The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone. This study will recruit inner-city children and adolescents with moderate to severe allergic asthma. This study will last about 1.5 to 2 years. Participants will be randomly assigned to receive either omalizumab or placebo injections once every 2 or 4 weeks. The injection schedule will be determined based on the participant's weight and total IgE. Both groups will receive standardized specialist care and basic asthma education including environmental control measures. Participants must have some form of health care insurance to cover the costs of asthma controller medications prescribed during the study. Participants will complete a series of questionnaires about topics including perceived stress, home environment, physical activity, diet and nutrition, smoking habits, and quality of life. At study entry and monthly throughout the study, participants will complete questionnaires about their asthma symptoms and medical resource utilization. Some visits will include a physical examination, vital signs measurement, lung function tests, asthma medication evaluation, and an asthma action plan. Blood collection is required up to eight times during the study for safety labs. | ||||||
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| DOI: | 10.21430/M3V7CAZ3NP | ||||||
| Subjects: | 419 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY212: Apoptosis and other immune biomarkers predict influenza vaccine (TIV 2008) responsiveness | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 30 young (20-30 years) and 59 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health. | ||||||||||||
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| DOI: | 10.21430/M37NGTHMDS | ||||||||||||
| Subjects: | 91 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY223: A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis | |||||||
| Status: | Updated | ||||||
| Description: | Over the last two decades, the prevalence of asthma has dramatically increased in many parts of the world. Currently, there are no effective ways to prevent the development of nasal allergies and asthma, and there are no cures for these diseases. Sublingual immunotherapy (SLIT) may help reduce symptoms of allergy and asthma. The purpose of this study is to evaluate the safety and efficacy of a cockroach extract given sublingually to adults with perennial (year-round) nasal allergies, asthma, or both. At study entry, participants will receive a dose of placebo and then up to five incremental doses of cockroach extract or placebo at 15-minute intervals while observed by the clinical research staff. Doses will continue to be given until a sign or symptom occurs that indicates the participant is having difficulty tolerating the drug, or until the maximum study dose is reached. For the next 6 months, participants will take the maximum study dose of cockroach extract or placebo daily at home. This study will consist of 8 study visits. Skin tests, breathing tests, and blood collection will occur at study screening and other visits during the study. At study entry, participants will be taught to use an EpiPen in the event of a severe allergic reaction at any time during the study. A physical and oral exam, breathing test, and blood collection will occur at study entry and all follow-up visits. | ||||||
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| DOI: | 10.21430/M34X4ULP41 | ||||||
| Subjects: | 54 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||