DR33 DataRelease
Release Date: 01/29/2020
| SDY787: T cell immune signature of whole cell vs acellular pertussis vaccination in healthy individuals | |||||||||||||
| Status: | New | ||||||||||||
| Description: | T cell immune signature of whole cell (wP) vs acellular pertussis (aP) vaccination as well as priming in healthy individuals was studied. Healthy adults originally primed with either aP or wP were recruited. A subset of these donors was boosted with aP and subsequently tested 0.5 to 44 months after the boost. | ||||||||||||
| Program/Contract: |
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| DOI: | None | ||||||||||||
| Subjects: | 144 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY1331: Efficacy of Islet After Kidney Transplantation (CIT-06) and Extended Follow Up after Islet Transplantation in Type 1 Diabetes (CIT-08) | ||||||||||||||||||||||||||||||||||
| Status: | New | |||||||||||||||||||||||||||||||||
| Description: | The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. Unlike the other studies, subjects in CIT06 had previously received a kidney transplant and were receiving maintenance immunosuppression. CIT06 was a single arm Phase 3 license-supporting study. At the time of islet transplant, subjects in CIT06 received induction therapy in an open-label fashion with rabbit anti-thymocyte globulin (ATG, 5 doses; daclizumab or basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable) and etanercept. Subjects remained on their calcineurin-based maintenance immunosuppression regimen already in place for their renal allograft. | |||||||||||||||||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M33GZ8UR05 | |||||||||||||||||||||||||||||||||
| Subjects: | 24 | |||||||||||||||||||||||||||||||||
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| SDY1335: Immune Profiling Assay Development for Pertussis vaccines | |||||||
| Status: | New | ||||||
| Description: | Enrollment min/max Age Unit is years old | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3T5G6GG5X | ||||||
| Subjects: | 72 | ||||||
| Study PI, contact: |
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1402: PROGENI-KI (CTOT-08) | |||||||
| Status: | New | ||||||
| Description: | Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it working for a long time. One field of interest is how one's cellular make-up might affect the body's immune response (body's natural defense system to illness and foreign things) to a kidney transplant. Cellular tests, like gene expression, help doctors to study a person's cellular traits. Gene expression is when information found in one's DNA is translated into RNA and eventually proteins. These components are present in each of the body's cells. In this study, researchers are trying to learn if certain changes in the RNA and proteins found in blood, urine, or transplant biopsy tissue can detect rejection before injury can occur or become too severe. The blood and urine tests will look for patterns in one's DNA (called genetic markers). This study will follow subjects for 2 years after transplant. There will be a total of 12 study visits with additional study visits if rejection occurs. The study requires additional samples of blood, urine, and tissue to be collected during routine clinical visits and biopsies (a procedure to remove and examine a small piece of kidney tissue). | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3Z4SLIS4Q | ||||||
| Subjects: | 307 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1466: Monozygotic and Dizygotic Twin Pair T-Cell Responses to Influenza Vaccination SLVP018 2013 | |||||||
| Status: | New | ||||||
| Description: | Evaluate the variation in immune response between individuals and assess whether it changes as a function of age and similarity in genetic and environmental background (by comparing differences between monozygotic and dizygotic twin pairs of different ages). | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M33B64BQUE | ||||||
| Subjects: | 20 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1468: B-cell Immunity to Influenza (SLVP017) 2010 | |||||||
| Status: | New | ||||||
| Description: | Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M30IB1ZZDJ | ||||||
| Subjects: | 70 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1469: B-cell Immunity to Influenza (SLVP017) 2011 | |||||||
| Status: | New | ||||||
| Description: | Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3HXQPVM9E | ||||||
| Subjects: | 21 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1471: B-cell Immunity to Influenza (SLVP017) 2013 | |||||||
| Status: | New | ||||||
| Description: | Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3WEPI1HA3 | ||||||
| Subjects: | 8 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1475: Expanded PD-1hi CXCR5- T peripheral helper cells promote B cells responses in lupus via IL-21 | |||||||
| Status: | New | ||||||
| Description: | Evaluate the T cell populations altered in the circulation of patients with SLE by highdimensionalmass cytometry. We identify a highly expanded population of PD-1hi CXCR5- Tcells in SLE patients, including in early SLE patients studied prior to initiation of strongimmunosuppressive therapies. By phenotype, transcriptome, and function, these cells are Tphcells, a peripherally homing B cell helper population | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M32K1Q3IAP | ||||||
| Subjects: | 64 | ||||||
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| SDY1513: Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults (CoFAR1) | |||||||
| Status: | New | ||||||
| Description: | This Phase 1 multi-center, non-randomized, open label safety trial will investigate the safety of EMP-123, a rectally administered vaccine consisting of three recombinant modified peanut antigens encapsulated within dead E. coli. EMP-123 will be administered to healthy volunteers for 4 weekly administrations of the study product in a dose escalation manner followed by 4 weeks of follow-up, then a Data Safety Monitoring Board (DSMB) review. If no safety concerns are noted, 10 peanut allergic subjects will be enrolled with weekly dose escalation of the study product for 10 weeks followed by biweekly treatment at a fixed dose (same dose as 10th dose) for 6 weeks. These subjects will then return in 4 weeks for a final assessment. If a delay in dose escalation is required (as defined in Section 6.6), the dose may be escalated during the biweekly dosing interval. Only a single repeat dose or dose reduction will be permitted in this trial. Dosing will not be continued beyond 13 doses or 16 weeks, and the dose will not be escalated beyond 3,063 ug (total modified peanut protein with no adjustment for body weight). | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3UEJMBVUI | ||||||
| Subjects: | 28 | ||||||
| Study PI, contact: |
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| Publications: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1514: An Observational Study of Childhood Food Allergy (CoFAR2) | |||||||
| Status: | New | ||||||
| Description: | This observational study will investigate the developmental immunology of peanut, egg, and milk allergy in a cohort of milk- or egg-allergic children who are at risk for peanut allergy. This strategy will help to delineate, compare, and contrast biological markers and immunologic changes associated with the development of peanut allergy and loss of egg and milk allergy, while simultaneously evaluating important clinical and environmental influences likely to account for the recent rise in the prevalence of these allergies. The hallmark of food-allergic disease is the production of food-specific Immunoglobulin E (IgE) antibodies that represent an end result of a T helper 2 (Th2) influenced immune response. Currently, there is only a limited understanding of the mechanisms involved in the developmental course of food allergies. To effectively prevent or reverse the progression of food allergy, immune interventions will be needed. Furthermore, it is likely that successful strategies will need to be directed to those persons at identifiable risk (e.g., who have biomarkers associated with development of peanut allergy). | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3CCG5XNFF | ||||||
| Subjects: | 515 | ||||||
| Study PI, contact: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1515: Peanut Sublingual Immunotherapy (CoFAR4) | |||||||
| Status: | New | ||||||
| Description: | Peanut allergy is a common ailment in the United States. Research suggests that the prevalence of peanut allergy in the United States has doubled over the last 5 years. Currently, the only effective treatment for peanut allergy is a peanut-free diet and quick access to self-injectable epinephrine in the event of peanut exposure. The sublingual route is a potential method to administer immunotherapy for the treatment of food allergies. The intent of this study is to induce desensitization and eventually tolerance to peanut protein and evaluate the safety and immunologic effects of daily sublingual immunotherapy (SLIT) for individuals with peanut allergy. The trial will enroll 40 participants. After the first 10 participants between the ages of 18 and 40 are enrolled, safety information will be reviewed. If there are no safety concerns, the study will continue to enroll the remaining participants between the ages of 12 and 40. This clinical trial will last 172 to 216 weeks. Participants will be randomly assigned to receive peanut SLIT or placebo SLIT. All participants will have an entry oral food challenge (OFC). The treatment group will receive gradual dosing escalations of peanut SLIT and maintenance therapy over a 44-week period, followed by another OFC. Following the OFC, participants will be unblinded, and the placebo group will receive peanut SLIT escalated to a higher maximum dose than the first treatment group. Maintenance therapy will continue for both groups for more than 2 years. Study visits will occur every 2 weeks during dosing escalations of peanut SLIT, followed by visits gradually spacing out during maintenance to every 12 weeks. At selected visits, a physical examination, skin prick tests, blood and urine collection, and atopic dermatitis and asthma evaluations will occur. Approximately 6 OFCs will be administered to each participant throughout the course of the study. Additionally, 10 participants will be enrolled as control participants who will not receive any study therapy and will only have blood drawn at 3 visits throughout the course of the trial. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3UH9QGIY2 | ||||||
| Subjects: | 62 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1519: Eosinophilic Esophagitis Databank (CoFAR5) | ||||||||||
| Status: | New | |||||||||
| Description: | This is a multi-site, single visit registry in subjects aged 6 months to 65 years old, of any race, gender, or ethnicity with a biopsy confirmed EoE. Participants/parents/guardians will provide responses regarding the medical history, and will provide salivary and/or blood samples. The study team will have access to the participant's medical record to verify diagnosis information and medical history. | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M36BWCCNH7 | |||||||||
| Subjects: | 709 | |||||||||
| Study PI, contact: |
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| Assays: | None | |||||||||
| Clinical Assessments: | None | |||||||||
| SDY1520: Peanut Epicutaneous Immunotherapy (CoFAR6) | |||||||
| Status: | New | ||||||
| Description: | This is a multi-center, randomized, double-blind, placebo-controlled trial of DBV712 (Viaskin Peanut) in peanut-allergic subjects reacting to <1044 mg of peanut protein in an OFC. Subjects will be randomized to two doses of Viaskin Peanut patch or matched placebo (1:1:1) and then will undergo a 5044 mg of peanut protein OFC at week 52, designed to investigate the efficacy, safety and immunologic effects of Viaskin Peanut patch treatment for peanut allergy. Active Viaskin Peanut patch dosing will be with 100 ?g and 250 ?g patches applied every 24 hours and Viaskin placebo patch dosing will be with a placebo (no antigen) patch applied every 24 hrs. At 52 weeks, a 5044 mg of peanut protein OFC will occur. After the 52-week OFC the subject will be unblinded. In the unlikely event that an active subject on active treatment passes the week 52 OFC and has a peanut-specific IgE<2 kUA/L, he/she will discontinue dosing for up to 20 weeks. Sustained unresponsiveness (defined in Section 1.1) will be assessed with a 5044 mg of peanut protein OFCs, followed by an open feeding at 8 weeks, and if negative, again at 20 weeks. Those who pass the OFC after 20 weeks off treatment will be instructed to add peanut to their diet. Those that fail either of these OFCs will resume dosing as described in section 3. Subjects who fail the week 52 OFC, either active or placebo will dose with the 250 ?g dose from the time of unblinding (~ week 52) through week 130. After the 52-week OFC, placebo-treated subjects who do not demonstrate sustained unresponsiveness, will cross-over to active treatment at a dose of 250 ?g daily for a total of 30 months (130 weeks) of active therapy. At the end of study, all subjects will undergo a 5044 mg of peanut protein OFC on treatment; those who pass the OFC will have treatment discontinued and will have an OFC at 8 weeks and 20 weeks, to assess for sustained unresponsiveness off of therapy. Throughout the protocol, all subjects will remain on a peanut-free diet for the duration of active therapy and through any challenges after therapy is completed. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M397ZURMSI | ||||||
| Subjects: | 86 | ||||||
| Study PI, contact: |
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| Publications: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1533: Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes (CIT-03) and Extended Follow Up after Islet Transplantation in Type 1 Diabetes (CIT-08) | |||||||||||
| Status: | New | ||||||||||
| Description: | The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. The focus of CIT03 was to evaluate the investigational agent, deoxyspergualin. Subjects in CIT03 received rabbit anti-thymocyte globulin (ATG; basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), deoxyspergualin, etanercept, sirolimus, and low-dose tacrolimus in an open-label fashion. | ||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3Z6I3UMVL | ||||||||||
| Subjects: | 14 | ||||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||||
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| Assays: | None | ||||||||||
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| SDY1535: TIGIT is upregulated by HIV-1 infection and marks a highly functional adaptive and mature subset of natural killer cells | |||||||
| Status: | New | ||||||
| Description: | Performed a mass cytometry-based screen of NK cell receptor expression patterns in healthy controls and HIV+ individuals and then focused mechanistic studies on the expression and function of T cell immunoreceptor with Ig and ITIM domains (TIGIT) | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M368XIMING | ||||||
| Subjects: | 50 | ||||||
| Study PI, contact: |
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1544: LEA29Y (Belatacept) Emory Edmonton Protocol (LEEP) (CIT-04) and Extended Follow Up after Islet Transplantation in Type 1 Diabetes (CIT-08) | |||||||||||
| Status: | New | ||||||||||
| Description: | The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. The focus of CIT04 was to evaluate the effectiveness of an IS regimen that included belatacept. For immunosuppression, CIT04 subjects received belatacept, basiliximab, and mycophenolate mofetil in an open-label fashion. | ||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3F5QE35RO | ||||||||||
| Subjects: | 10 | ||||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||||
| Resources: |
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| Assays: | None | ||||||||||
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| SDY1550: Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy (CoFAR7) | |||||||
| Status: | New | ||||||
| Description: | This is a multi-center, randomized, open label study to investigate sustained unresponsiveness induction and safety of Baked Egg vs. Egg OIT, for OFC documented egg allergy, in individuals who pass a 2 gm baked egg protein OFC. All eligible subjects will receive a double-blind placebo controlled baked egg OFC. Individuals who pass the baked egg OFC will then have a double-blind placebo controlled egg OFC. Those who react at a cumulative dose of <= 1444 mg of egg white protein will be randomized 1:1 to Baked Egg or Egg OIT. Approximately 40 of the first individuals who do not pass the initial baked egg food challenge will be assigned to Egg OIT and are the Egg OIT assignment group. Those who tolerate more than 1444 mg of egg white protein on the egg OFC will not be eligible for the study and will be followed per site standard of care. All eligible and enrolled subjects will have a 1 year and a 2 year OFC. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3UFZVM91I | ||||||
| Subjects: | 187 | ||||||
| Study PI, contact: |
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY1553: Strategies to Improve Long Term Islet Graft Survival (CIT-02) and Extended Follow Up after Islet Transplantation in Type 1 Diabetes (CIT-08) | |||||||||||
| Status: | New | ||||||||||
| Description: | The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. The CIT02 protocol focused on treating islets pre-transplant, and subjects were randomized to receive islets prepared with either Lisofylline or Exenatide. For induction and maintenance immunosuppression, the subjects received rabbit anti-thymocyte globulin (ATG; basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable), etanercept, sirolimus, and tacrolimus in an open-label fashion. | ||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3VGVKPRV0 | ||||||||||
| Subjects: | 6 | ||||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||||
| Resources: |
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| Assays: | None | ||||||||||
| Clinical Assessments: |
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| SDY1554: B-Lymphocyte Immunotherapy in Islet Transplantation (CIT-05) and Extended Follow Up after Islet Transplantation in Type 1 Diabetes (CIT-08) | |||||||||||
| Status: | New | ||||||||||
| Description: | The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. Subjects in CIT05 received, in an open label-fashion, the anti-CD20 agent rituximab in combination with rabbit anti-thymocyte globulin (ATG; daclizumab or basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable) for induction and sirolimus alone for maintenance, a calcineurin-inhibitor free regimen. | ||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M38DLILKD5 | ||||||||||
| Subjects: | 2 | ||||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||||
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| Assays: | None | ||||||||||
| Clinical Assessments: |
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| SDY1594: Modified CyTOF Helios Injector Can Improve Data Quality | |||||||
| Status: | New | ||||||
| Description: | Healthy donor PBMCs were collected, CD45 barcoded, pooled and stained with a standard immunophentyping panel. The stained and fixed cells were then divided into multiple aliquots, frozen and distributed to 7 institutions and acquired on 10 separate Helios mass cytometers using both the standard and modified acqusition protocols to evaluate staining quality and inter-instrument variability | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3O1ZSRR7P | ||||||
| Subjects: | 5 | ||||||
| Study PI, contact: |
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| Clinical Assessments: | None | ||||||
| SDY1598: Epidemiological Evidence for Lineage-Specific Differences in the Risk of Inapparent Chikungunya Virus Infection | |||||||
| Status: | New | ||||||
| Description: | Estimate the ratio of symptomatic to asymptomatic CHIKV infections (S:A ratio), elucidate sign and symptom cooccurrence, characterize the probability of infection and disease occurrence across age, identify risk factors associated with infection and disease outcomes, and quantify differences in the proportions of inapparent CHIKV infections between the Asian CHIKV lineage and the ECSA CHIKV lineage | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3IANCCO4A | ||||||
| Subjects: | 296 | ||||||
| Study PI, contact: |
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| Clinical Assessments: | None | ||||||
| SDY25: Genotyping and gene function in healthy volunteers | |||||||||||
| Status: | Updated | ||||||||||
| Description: | The goal of this study is to create a pool of potential subjects genotyped in a manner identical to that used in the AVA000 trial population. Subjects were screened for exclusion based on history of chronic infectious or immune diseases and to avoid sampling during current acute infection. Genotyping data are available for reference purposes. The subjects agreed to be available to be recalled for sampling of blood for ex vivo studies of differential immunologic function of genetic variants corresponding to those associated with variation in vaccine response. |
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| Program/Contract: |
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| DOI: | 10.21430/M3L5GO913J | ||||||||||
| Subjects: | 1426 | ||||||||||
| Study PI, contact: |
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| Assays: |
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| Clinical Assessments: | None | ||||||||||
| SDY180: Systems scale interactive exploration reveals quantitative and qualitative differences in response to 2009-2010 Fluzone influenza vaccine and pneumococcal vaccine | |||||||||||||||||
| Status: | Updated | ||||||||||||||||
| 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. | ||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3I44H8R17 | ||||||||||||||||
| Subjects: | 46 | ||||||||||||||||
| Study PI, contact: |
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| Clinical Assessments: | None | ||||||||||||||||
| SDY211: Inner-City Anti-IgE Therapy for Asthma (ICATA/ICAC-08) | |||||||
| 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. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3V7CAZ3NP | ||||||
| Subjects: | 419 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY218: Oral Immunotherapy for Childhood Egg Allergy (CoFAR3) | ||||||||||
| Status: | Updated | |||||||||
| Description: | In the United States, as many as 6% to 8% of children are affected by food allergy. In young children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The usual standard of care for allergy is complete avoidance of this food allergen and treatment of accidental systemic reactions by access to self-injected epinephrine. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since standard injection (under the skin) immunotherapy for food allergy is associated with a high rate of allergic reactions, a few studies have recently tried oral immunotherapy (OIT) in food allergy. The purpose of this study is to determine the safety and efficacy of the administration of OIT. The intent is to develop desensitization and eventually tolerance to egg allergen. This study will evaluate tolerance to egg white solid that may be gained by gradually increasing the amounts of egg white solid given to a child over a long period of time. This study will last up to 48 months. The participants will be randomly assigned to receive oral immunotherapy treatment with egg white solid or placebo. This study will include dose escalation and maintenance followed by oral food challenge (OFC). For participants receiving egg OIT, visit 1 consists of multiple small incremental doses of egg white solid. This is followed by 32-40 weeks of gradual dose escalation to a stable maintenance dose of egg white solid for at least 8 weeks. At approximately Week 44, participants are given an OFC using 5 grams of egg white solid to identify desensitized individuals. Participants and study staff are unblinded following this initial OFC. Maintenance egg OIT therapy is continued for an additional 1-3 years. Oral Food Challenges with 10 grams of egg white solid will be performed for participants on maintenance egg OIT at subsequent time points (approximately Week 96 and annually thereafter) to test for desensitization. If passed, a repeat OFC after being off therapy for 4-6 weeks will be performed to test for tolerance. An OFC to test for tolerance will use 10 grams of egg white solid and be followed by an open feeding of egg. Participants receiving placebo during dose escalation and maintenance are given an OFC using 5 grams of egg white solid to test for desensitization at approximately 44 weeks. They are unblinded at that time, continue on an egg-restricted diet, and are followed until up to 2 years. These participants will only receive an OFC at a subsequent time point if their egg Immunoglobulin E (IgE) declines to be less than 2 kilounits of antibody per liter; this OFC will use 10 grams of egg white solid and be followed by an open feeding of egg. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur. |
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| Program/Contract: |
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| DOI: | 10.21430/M3Q2O0X9Z5 | |||||||||
| Subjects: | 55 | |||||||||
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| Clinical Assessments: | None | |||||||||
| SDY311: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) SLVP015 2010 (See companion studies SDY315 2012 / SDY312 2009 / SDY314 2008 / SDY112 2011) | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M33MSDRJ55 | ||||||||||||
| Subjects: | 76 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY315: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination (TIV) SLVP015 2012 (See companion studies SDY311 2010 / SDY312 2009 / SDY314 2008 / SDY112 2011) | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3CJT3NCT2 | ||||||||||||
| Subjects: | 74 | ||||||||||||
| Study PI, contact: |
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| Clinical Assessments: | None | ||||||||||||
| SDY400: Immunologic and genomic signatures of influenza vaccine response - 2012 (see companion studies SDY63, SDY404, SDY520) | |||||||||
| Status: | Updated | ||||||||
| Description: | Project 1: Immunologic and genomic signatures of influenza vaccine response - year3 2012 | ||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3U7GDOFIT | ||||||||
| Subjects: | 98 | ||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY404: Immunologic and genomic signatures of influenza vaccine response - 2011 (see companion studies SDY63, SDY400, SDY520) | |||||||||||
| Status: | Updated | ||||||||||
| Description: | Project 1: Immunologic and genomic signatures of influenza vaccine response - year2 2011 | ||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3GWQRC8DT | ||||||||||
| Subjects: | 72 | ||||||||||
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| Clinical Assessments: | None | ||||||||||
| SDY478: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination SLVP015 2013 | |||||||||
| Status: | Updated | ||||||||
| Description: | Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people. | ||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3YEJTSS29 | ||||||||
| Subjects: | 70 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY520: Immunologic and genomic signatures of influenza vaccine response - 2013 (see companion studies SDY63, SDY404, SDY400) | |||||||
| Status: | Updated | ||||||
| Description: | Project 1: Immunologic and genomic signatures of influenza vaccine response - year4 2013 | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3KVVHM735 | ||||||
| Subjects: | 61 | ||||||
| Study PI, contact: |
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| Publications: | None | ||||||
| Resources: |
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| Clinical Assessments: | None | ||||||
| SDY619: ADRN Barrier/Immunoprofiling Exploratory Pilot Study (ADRN-04) | |||||||
| Status: | Updated | ||||||
| Description: | Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People with atopic dermatitis have defects in the skin barrier as well as defects in the immune system which fights off skin infections. People who have atopic dermatitis often have complications from viral and bacterial skin infections, such as recurring Staphylococcus aureus (S. aureus), or Staph infections. The purpose of this study is to look at how defects in the skin barrier and immune response affect risk for skin infections. The study will compare the skin barrier and immune response of people with and without atopic dermatitis in relation to whether Staph bacteria is growing on their skin. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M384Z5ZXPI | ||||||
| Subjects: | 150 | ||||||
| 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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| SDY640: Immunologic and genomic signatures of influenza vaccine response - 2014 | |||||||
| Status: | Updated | ||||||
| Description: | Project 1: Immunologic and genomic signatures of influenza vaccine response - year5 2014 | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3A6GYD5L0 | ||||||
| Subjects: | 37 | ||||||
| Study PI, contact: |
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| Publications: | None | ||||||
| Resources: |
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| Clinical Assessments: | None | ||||||
| SDY887: Defective signaling in aging, influenza vaccination 2007 SLVP015 | |||||||
| Status: | Updated | ||||||
| Description: | Pilot year. 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 10 young (20-30 years) and 19 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. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M33JMYFLF1 | ||||||
| Subjects: | 29 | ||||||
| Study PI, contact: |
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| Clinical Assessments: | None | ||||||
| SDY997: AMP Lupus Network Project: Molecular Characterization of Lupus Nephritis and Correlation with Response to Therapy | ||||||||||
| Status: | Updated | |||||||||
| Description: | Phase I will be devoted to the study of at least 45 subjects with lupus nephritis and 25 controls with the intent of achieving the following goals: (i) to assess feasibility of obtaining a sufficient yield of high quality data based on current and refined AMP SOPs, (ii) to assess recruitment rates and the number of sites necessary to effectively recruit for Phase II, (iii) to ensure that the technologies developed in Phase 0 are working well, especially with regard to transport and scaling up to handle specimens from multiple sites; (iv) to demonstrate that the selected technologies can be used for the purpose of reliably differentiating lupus nephritis kidneys from kidney tissue without lupus nephritis, (v) where necessary, to further refine the technologies before embarking on a large-scale project; and most importantly (vi) to provide critical data upon which to make rational decisions about key elements of the Phase II study design (e.g., eligibility criteria, estimates of variation for power calculations, and site-specific capability regarding patient recruitment, specimen handling, etc.). | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M35FLWNXH1 | |||||||||
| Subjects: | 107 | |||||||||
| Study PI, contact: |
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| SDY998: AMP Rheumatoid Arthritis Phase 1 | ||||||||||||||||||||||||||||
| Status: | Updated | |||||||||||||||||||||||||||
| Description: | The primary goal for RA arthroplasty P1 studies are: To establish if molecular signatures and pathways identified using core AMP technologies differ between OA and RA in 20 RA surgical samples and 10 OA arthroplasty samples. | |||||||||||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3KXJHSP4T | |||||||||||||||||||||||||||
| Subjects: | 62 | |||||||||||||||||||||||||||
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| SDY1039: Scleroderma: Cyclophosphamide or Transplantation (SCOT) | |||||
| Status: | Updated | ||||
| Description: | This prospective, randomized, open-label, multi-center, 2-arm, Phase II clinical trial will randomize approximately 114 subjects with severe SSc in the United States and Canada. Subjects will be randomly assigned in a 1:1 ratio to a treatment of high-dose immunosuppressive therapy with autologous stem cell rescue (HDIT transplantation) or to treatment of monthly pulse IV cyclophosphamide. Subjects will be stratified by treatment center. The initial treatment period will be approximately 3 months for the HDIT transplantation arm (from the time of initiation of mobilization until the day of transplant) and 12 months for the cyclophosphamide arm. Subjects will be followed for up to 72 months after randomization. The study will continue for 54 months after the last subject is randomized. | ||||
| Program/Contract: |
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| DOI: | 10.21430/M3SM4YLTLH | ||||
| Subjects: | 141 | ||||
| Study PI, contact: |
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| SDY1299: Identification of Three Rheumatoid Arthritis Disease Subtypes By Machine Learning Integration of Synovial Histologic Features and RNA Sequencing Data | |||||||
| Status: | Updated | ||||||
| Description: | Gene expression analysis of RA and OA synovial tissue revealed 3 distinct synovial subtypes. These labels were used to generate a histologic scoring algorithm in which the histologic scores were found to be associated with parameters of systemic inflammation, including the erythrocyte sedimentation rate, CRP levels, and autoantibody levels. Comparison of gene expression patterns to clinical features revealed a potentially clinically important distinction: mechanisms of pain may differ in patients with different synovial subtypes. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3V2G6PBYS | ||||||
| Subjects: | 45 | ||||||
| Study PI, contact: |
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| SDY1328: Transcriptional profiling of HBV-naive subjects before vaccination against Hepatitis A/B viruses, Diphtheria/Tetanus toxoids and Cholera. | |||||||
| Status: | Updated | ||||||
| Description: | Mechanisms of poor responses to vaccines remain unknown. Hepatitis B virus-naive elderly subjects received three vaccines, including a vaccine against hepatitis B virus (HBV). Pre-vaccination high dimensional analyses of blood using transcriptional profiling and flow cytometry revealed that subjects having increased memory B cell frequencies and higher expression of genes downstream of B cell receptor signaling responded more strongly to the HBV vaccine whereas subjects having higher expression of inflammatory related genes and greater numbers of activated innate immune cells showed a weaker response to this vaccine. The heme-induced response was associated with the poor response to the hepatitis B vaccine. Transcriptional profiling and flow cytometry results were validated in a distinct set of elderly subjects with accuracy greater than 60%. Our study is the first that identifies baseline predictors of responses to vaccines in a population of subjects known to be highly susceptible to infections. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3ID8ZC1AT | ||||||
| Subjects: | 174 | ||||||
| Study PI, contact: |
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| Publications: |
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| Clinical Assessments: | None | ||||||
| SDY1364: Roles for Treg Expansion and HMGB1 Signaling through the TLR1-2-6 Axis in Determining the Magnitude of the Antigen-Specific Immune Response to MVA85A | |||||||
| Status: | Updated | ||||||
| Description: | A better understanding of the relationships between vaccine, immunogenicity and protection from disease would greatly facilitate vaccine development. Modified vaccinia virus Ankara expressing antigen 85A (MVA85A) is a novel tuberculosis vaccine candidate designed to enhance responses induced by BCG. Antigen-specific interferon-_ (IFN-g) production is greatly enhanced by MVA85A, however the variability between healthy individuals is extensive. In this study we have sought to characterize the early changes in gene expression in humans following vaccination with MVA85A and relate these to long-term immunogenicity. Two days post-vaccination, MVA85A induces a strong interferon and inflammatory response. Separating volunteers into high and low responders on the basis of T cell responses to 85A peptides measured during the trial, an expansion of circulating CD4+ CD25+ Foxp3+ cells is seen in low but not high responders. Additionally, high levels of Toll-like Receptor (TLR) 1 on day of vaccination are associated with an increased response to antigen 85A. In a classification model, combined expression levels of TLR1, TICAM2 and CD14 on day of vaccination and CTLA4 and IL2R_ two days post-vaccination can classify high and low responders with over 80% accuracy. Furthermore, administering MVA85A in mice with anti-TLR2 antibodies may abrogate high responses, and neutralising antibodies to TLRs 1, 2 or 6 or HMGB1 decrease CXCL2 production during in vitro stimulation with MVA85A. HMGB1 is released into the supernatant following atimulation with MVA85A and we propose this signal may be the trigger activating the TLR pathway. This study suggests an important role for an endogenous ligand in innate sensing of MVA and demonstrates the importance of pattern recognition receptors and regulatory T cell responses in determining the magnitude of the antigen specific immune response to vaccination with MVA85A in humans. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3NJTLGRT4 | ||||||
| Subjects: | 24 | ||||||
| Study PI, contact: |
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| Publications: |
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| Clinical Assessments: | None | ||||||
| SDY1464: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination SLVP015 2014 | |||||||
| Status: | Updated | ||||||
| Description: | Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3AUKDIXFI | ||||||
| Subjects: | 99 | ||||||
| Study PI, contact: |
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| Clinical Assessments: | None | ||||||