Active Protocols
09-H-0239 – "Cellular and molecular characterization of the immune response in healthy NIH employees at baseline, and after immunization with the H1N1 and seasonal influenza vaccines"
Protocol Team Lead: Schwartzberg and Germain
Informatics Lead: Tsang
Subjects: 143
Total samples: 635
Status: Complete, manuscript in preparation
09-H-0245 – "Characterization of the innate immune response in healthy NIH employees at baseline and after immunization with the H1N1 vaccine"
Protocol Team Lead: Perl and Trinchieri
Informatics Lead:
Subjects: 19
Total samples: 95
Status: Luminex run, Flow recently run and analyzed, data sent to bio info, miRNA to be run?
Gene Expression data analysis: Data preprocessing and quality control completed. Batch effect analysis and correction is completed. Analysis of coherently changed genes and pathways enriched by those genes is completed at first pass. Analysis of gene expression in naïve vs. non-naïve patients (at day0) is competed at first pass.
Flow cytometry data analysis: Cell populations gating completed. Data quality control completed. Analysis of variability and coherent changes in cell populations is completed. Analysis of correlations between gene expression and cell populations is in progress.
Cytokines data analysis: First pass analysis of coherent changes is completed.
Bioinformatics analysis has started.
11-H-0092 - "Effects of systemically administered hydrocortisone on the human immunome in healthy volunteers"
Protocol Team Lead: Olnes and Nussenblatt
Informatics Lead: Kotliarov
Subjects: 18
Total samples: 158
Status: Data analysis (gene expression and flow cytometry) is completed. Manuscript and Figures are in preparation
10-H-0165 - "Effects of Rosuvastatin on the Immune System in Healthy Volunteers with Normal Cholesterol"
Protocol Team Lead: Perl and
Informatics Lead:
Subjects: 11 normal CRP, 4 elevated CRP
Total samples: 51
Status: Luminex was run for low CRP, but there was a problem of batch, so both High CRP and low CRP will be rerun at the same time (this week). Flow will start next week (prob with Fortessa G610 PMT problem, and needed to revalidate HIPc panel with CD28 (per request)). For all 51samples gene expression experiments complete. First pass data analysis of collected data (gene expression, cytokines) is completed. Data analysis is on hold until new data acquisition (with more high-CRP patients).
Dysregulation of the Immune System in Hereditary Pulmonary Fibrosis Collaborator: Bernadette R. Gochuico, M.D. NHGRI
Protocol Team Lead: Gochuico and
Informatics Lead:
Subjects: 21
Total samples: 21
Status: Data acquisition, flow and cytokines run. Cytokines analyzed and released, flow panel being analyzed. Completed 21 gene expression and 21 miR profiling experiments
Evaluation of the Immunome in High Inflammatory and Stable Multiple Sclerosis Collaborator: Bibi Bielekova, M.D. NINDS
Protocol Team Lead: Bielekova and
Informatics Lead:
Subjects: 10 high inflammatory (1 sample) enrolled and 10 stable immunized with seasonal flu (5 enrolled)
Total samples: 40
Status: Enrolling
Study of the immunome in patients with Cushing’s disease before and after curative surgery Collaborator: Lynnette Nieman, M.D. NICHD
Protocol Team Lead: Nieman and
Informatics Lead:
Subjects: 10 (6 enrolled)
Total samples: 20
Status: Enrolling
Peptide B27 (OptiquelTM) as Corticosteroid–Sparing Therapy for Chronic Non-Infectious Uveitis Collaborator: Robert Nussenblatt, M.D., M.P.H., NEI
Protocol Team Lead: Nussenblatt and
Informatics Lead:
Subjects: 40 (34 enrolled)
Total samples: 80
Status: Enrolling
Assessment of Alterations in Immune Function During Pregnancy and Post Parturition Collaborator: Christa S. Zerbe, M.D. NIAID
Protocol Team Lead: Zerbe and
Informatics Lead:
Subjects: 40 (26 subjects enrolled)
Total samples: 160 plus 2 additional for each subject immunized with seasonal influenza vaccine.
Status: Enrolling
11-H-0268 The safety and tolerability of ultra low dose interleukin-2 (aldesleukin) in healthy volunteers Collaborator: Sawa Ito M.D. NHLBI
Protocol Team Lead: Ito and
Informatics Lead:
Subjects: 18
Total samples: 162
Status: Completed Enrollment and sample collection for 21 subjects. Completed 120 gene expression experiments. First 18 patients were run for luminex. Waiting for the enrollment of the new dose to be finished to run flow.
J1293 Cellular and Molecular Characterization of the Immune Response Before and After Immunization with Seasonal Influenza Vaccine in Adult Patients Who have completed Treatment for Acute Myeloid Leukemia Collaborator: Christopher Hourigan M.D., Ph.D. NHLBI
Protocol Team Lead: Hourigan & Biancotto
Informatics Lead:
Subjects: 10
Total samples: 21
Status:
Recruitment (JHH) – completed
Flow (CHI)- pending
Luminex (CHI) – pending
Microarray ( CHI) – completed
B-cell ELISPOT (NIAID) – completed
Titers (FDA) – pending – will be run end May/Early June.
Preliminary proteomics data for 10 normal and 10 AML patients are collected with Invitrogen ProtoArray Human Protein Microarrays. Data QC and analysis is in progress.
Phenotyping of the immune system of patients with Generalized Vitiligo Collaborator: Rebat Halder M.D. Chief of Dermatology, Howard University
Protocol Team Lead: Perl and
Informatics Lead:
Subjects: 20
Total samples: 40 (before and after narrow band UVB light therapy). Both blood and tissue samples will be obtained.
Status: Enrolling
IN DEVELOPMENT (Approved by CHI and ISAC)
Characterization of innate immune responses to AS03 adjuvanted H5N1 vaccine compared to non-adjuvanted H5N1 vaccine
Protocol Team Lead: Perl and
Informatics Lead:
Subjects: 50
Total samples: 450
Status: Protocol approved by IRB, amendment submitted in response to information from GSK and FDA, IND approved, CTA signed, drug to be shipped next week along with COA for FDA. Enrollment to start first week in June.
Phase I study of the safety of Herpes Simples Virus-2 (HSV-2) 529 vaccine in adults aged 18 to 50 years with and without HSV infection Collaborator: Jeffrey Cohen M.D. NIAID
Protocol Team Lead: Cohen and
Informatics Lead:
Subjects: 60 (3 cohorts: HSV-1+/HSV-2+, HSV-1+/HSV-2-, HSV-1-/HSV-2-). In each cohort subjects randomized in a ratio of 3:1 vaccine:control.
Total samples: 660
Status: All samples will be drawn and processed by NIAID according to CHI SOP. CHI may run HSV-1-/HSV-2- cohort first to determine if it is worthwhile to run the other cohorts. Protocol to IRB next week, planning for September 2013 start. Prospective participants are being screened.
Flow Cytometry Phenotyping in ClinSeq Donors with Disparate Coronary Artery Calcification Collaborators: Daniel McVicar NCI, Leslie Biesecker NHGRI
Protocol Team Lead: McVicar and Biancotto
Informatics Lead:
Subjects: 16
Total samples: 16
Status: Planning for phenotyping on fresh samples in order to include myeloid cells. Panels were developed and McVicar was informed. Waiting to hear from him for patients scheduling
Studies on the role of Autoreactive IgE in Lupus Collaborators: Juan Rivera and Richard Siegel NIAMS
Protocol Team Lead: Rivera and Biancotto
Informatics Lead:
Subjects: 20
Total samples: 120
Status: Planning for phenotyping on fresh samples in order to include myeloid cells, especially basophils. Panels are being developed. Specific panel was developed and QC. Need to contact Siegel for patient scheduling
Molecular Analysis of Protective Immunity in Malaria: A pilot observational study of experimental P. falciparum infection in healthy volunteers Collaborators: Kim Williamson Ph.D. and Peter Williamson M.D., Ph.D. NIAID
Protocol Team Lead: Drs. Williamson and
Informatics Lead:
Subjects: 10
Total samples: 60
Status: IRB approval problematic. If approved then CHI role will be determined.
Integrating Biosignatures of Human Immune Diseases
Collaborators: Raphaela Goldbach-Mansky (NIAMS) and Michelle Lowes (Rockefeller University)
Protocol Team Lead: Perl and
Informatics Lead: Tsang
Subjects: 20 monogenic and 20 polygenic
Total samples: 40 (one each subject)
Status: Application for U01 being submitted, logistical details will depend on whether funded or not.
OTHER STUDIES
Not included in the list are screening and sample acquisition protocols, small exploratory studies which have been completed (Boehm, Williamson, Tisdale), studies where only samples were provided (Rabin), and studies which are being developed but do not yet have CHI approval.
Last Updated May 2013
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