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Active Protocols

CHI Protocol Status Revised June 20, 2013

ACTIVE

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  submitted

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: . Complete luminex low/high CRP was rerun and analyzed. Currently results are discussed at staff meeting.
Flow was delayed due to instrument problems, and backup ordered (8 weeks for 1 reagent), will estimate running /analysis completed by mid-August (as personnel is taking time off)

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 analysis was done for all T cells tubes, need to QC NK1. Will release the results to bio informatics team in the next few days. 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 (Optiquel™) 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. Luminex pending on last enrollment group.

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) – completed and data release to Chris and Bio info
Microarray (all CHI) – completed
B-cell ELISPOT (NIAID) – completed
Titers (FDA) – completed
Bioinformatics (CHI) – pending –

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

12-H-0103 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: recruiting
Screened: 42
1st vaccination 6
labs pending 17
excluded based on HLA  4
excluded based on labs abnormalities 4
schedule conflicts 5
dropped after signing consent 2


IN DEVELOPMENT (Approved by CHI and ISAC)

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. Trial sample delivery were performed this week, if McVicar approves analysis layout, will schedule patients during.

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. 2 new neutrophils stainings were developed for McVicar and Riviera study. After validation, we ran 10 healthy individuals, and are meeting with Dr Rivera for analysis, layout validation, and 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.
Preliminarily we ran  2 patients: 1 NOMID untreated, 1 CANDLE
7 15 colors stainings were run, and plasma was saved for future luminex

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.

Development of a Tfh (T4 staining). First phase was done, and we now have 10 whole blood and10 PBMC analyzed.  Analysis layout needs to be validated (P. Schwartzberg). Really important tube, as it will be only extracellular markers, and will bring additional QC for the bio informatics team, as will not be influenced by fix/perm.

Lyoplates HIPc panel: round 3 central analysis before FOCIS meeting (end of june)

Set up of ELISPOT assay, S. Moir will assist us, and we agreed on having a delay in delivery of 4 weeks to be able to have a 4th UV LED light in the instrument, (which will improve to 8 colors detection) instead of 6.



Last Updated May 2013




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