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Active Protocols

CHI Protocol Status Revised February 11, 2014

Proposed Collaborative Clinical Trials/Studies with the Center for Human Immunology, Autoimmunity and Inflammation (CHI) word document icon (29.5 KB)

The Amount of Blood Needed for CHI Studies excel document icon (11.2 KB)

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 Leads: Schwartzberg and Germain
Informatics Lead: Tsang
Subjects: 143
Total samples: 635

Status: Primary manuscript in press in Cell. Further data mining is in progress.

09-H-0245 – Characterization of the innate immune response in healthy NIH employees at baseline and after immunization with the H1N1 vaccine

Protocol Team Leads: Bedognetti, Perl and Trinchieri
Informatics Lead: Kotliarov
Subjects: 19
Total samples: 95

Status: All data have been obtained. A team has formed headed by Davide Bedognetti. Data analysis and integration are in process.

11-H-0092 – Effects of systemically administered hydrocortisone on the human immunome in healthy volunteers

Protocol Team Leads: Olnes and Nussenblatt
Informatics Lead: Kotliarov
Subjects: 18
Total samples: 158

Status: Primary manuscript to be submitted shortly

10-H-0165 – Effects of rosuvastatin on the immune system in healthy volunteers with normal cholesterol

Protocol Team Lead: Perl
Subjects: 11 normal CRP, 7 elevated CRP
Total samples: 63

Status: Flow data being analyzed. 3 new high CRP subjects are just finishing sample collection and assays will begin shortly.

Dysregulation of the Immune System in Hereditary Pulmonary Fibrosis Collaborator: Bernadette Gochuico NHGRI

Protocol Team Leads: Gochuico and Perl
Informatics Leads: Kotliarov and Cheung
Subjects: 21
Total samples: 21

Status: Data acquisition complete. Analysis underway.

Evaluation of the Immunome in High Inflammatory and Stable Multiple Sclerosis Collaborator: Bibi Bielekova NINDS

Protocol Team Lead: Bielekova
Subjects: 10 high inflammatory (1 sample each, 5 enrolled), and 10 stable immunized with seasonal flu (6 enrolled)
Total samples: 40

Status: Enrolling, waiting for eligible subjects.

Study of the immunome in patients with Cushing’s disease before and after curative surgery Collaborator: Lynnette Nieman NICHD

Protocol Team Lead: Nieman
Subjects: 10 (6 enrolled)
Total samples: 20

Status: Enrolling, waiting for additional eligible subjects.

Peptide B27 (OptiquelTM) as corticosteroid–sparing therapy for chronic non-infectious uveitis Collaborator: Robert Nussenblatt NEI

Protocol Team Lead: Nussenblatt
Subjects: 33 enrolled
Total samples: 66

Status: Analysis of the clinical data did not detect a therapeutic effect of Peptide B27. The team is now considering whether to evaluate the samples in an effort to detect signatures of relapse vs. non-relapse.

Assessment of alterations in immune function during pregnancy and post parturition Collaborator: Christa S. Zerbe NIAID

Protocol Team Lead: Zerbe
Subjects: 40 (35 subjects enrolled and 6 immunized with influenza)
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 NHLBI

Protocol Team Leads: Ito and Perl
Informatics Leads: Kotliarov and Cheung
Subjects: 18
Total samples: 162

Status: Manuscript submitted

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 NHLBI

Protocol Team Leads: Hourigan and Biancotto
Subjects: 10
Total samples: 21

Status: 10 age and sex matched controls were obtained and analyses were rerun with controls at same time. Only flow remains, which will be done starting mid-November.

12-H-0103 Characterization of innate immune responses to AS03 adjuvanted H5N1 vaccine compared to non-adjuvanted H5N1 vaccine

Protocol Team Lead: Perl
Subjects: 40
Total samples: 560

Status: Waiting for final subjects to reach day 100, then lab analysis will begin.

Flow cytometry phenotyping in ClinSeq donors with disparate coronary artery calcification
Collaborators: Daniel McVicar NCI, Leslie Biesecker NHGRI

Protocol Team Leads: McVicar and Biancotto
Subjects: 16 (8 with calcification and 8 matched controls without)
Total samples: 16

Status: Enrolling, flow panels were developed for phenotyping myeloid cells in fresh samples. Eight subjects have been run.

Phase I study of the safety of herpes simplex virus-2 (HSV-2) 529 vaccine in adults aged 18 to 50 years with and without HSV infection
Collaborator: Jeffrey Cohen NIAID

Protocol Team Lead: Cohen
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. 4 subjects were enrolled in safety phase, no problems were observed so enrollment has just begun.

Characterization of the cellular and molecular effects of pioglitazone, a PPAR agonist, on the immune system in severe asthma.
Collaborator: Stewart Levine NHLBI

Protocol Team Leads: Levine and Perl
Subjects: 14
Total samples: 112

Status: Enrollment has begun, one subject enrolled to date.

Studies on the role of autoreactive IgE in lupus
Collaborators: Richard Siegel, Sarfaraz Hasni NIAMS

Protocol Team Leads: Hasni and Biancotto
Subjects: 20
Total samples: 120

Status: Panel has been developed and subjects enrolling (3 enrolled to date).

Mucosal and systemic immunologic and microbiomic perturbations caused by antibiotics in healthy women
Collaborator: Michail Lionakis NIAID

Protocol Team Leads: Lionakis and Perl
Subjects: 50
Total samples: 40

Status: Enrollment in progress. NIAID is collecting all samples. After determination of clinical outcomes CHI will confer with Dr. Lionakis to plan which subjects will have their immunome evaluated.

13-AR-0056 Stopping anti-tumor necrosis factor agents in rheumatoid arthritis
Collaborator: Michael Ward NIAMS

Protocol Team Leads: Ward and Perl
Subjects: 50
Total samples: 300

Status: Enrollment in progress. After determination of clinical outcomes CHI will confer with Dr. Ward to plan which subjects will have their immunome evaluated.



Last Updated February 2014




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