JOURNAL ONKOLOGIE – STUDIE

Occurrence of Antibodies Cross-reacting With Autoantigens in Primary EBV Infection

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05127980

Studienbeginn:
Oktober 2021

Letztes Update:
26.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Infections, Communicable Diseases, Epstein-Barr Virus Infections

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Basel, Switzerland

Collaborator:
-

Studienleiter

Michael Osthoff, PD Dr. med.
Principal Investigator
University Hospital Basel, Division of Internal Medicine

Kontakt

Michael Osthoff, PD Dr. med.
Kontakt:
Phone: +41 61 328 68 28
E-Mail: michael.osthoff@usb.ch» Kontaktdaten anzeigen

Samuel Etienne
Kontakt:
Phone: +41 61 556 5248
E-Mail: samuel.etienne@usb.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Basel, Division of Internal Medicine
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Michael Osthoff, PD Dr. med.
Phone: +41 61 328 68 28
E-Mail: michael.osthoff@usb.ch

Samuel Etienne
Phone: +41 61 556 5248
E-Mail: samuel.etienne@usb.ch» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Epstein-Barr Virus (EBV) is a lymphotropic herpes virus and the causative agent of infectious

mononucleosis (IM). The course of EBV infection is determined by the virus load and an

individuals' immune system state, which in turn is determined by the person's gene

composition, other infection history and several environmental factors, which all may

influence the immune capacity of a person to various degrees. Many diseases are known to be

associated with EBV infection, among those diseases are systemic autoimmune diseases. With

regard to EBV, prior infection with the virus seems to be of crucial importance for the

development of systemic lupus erythematosus (SLE). Autoantibodies against complement C1q

(anti-C1q) can be induced in vivo by the Epstein-Barr virus-derived antigenic site 'EBNA348'

(also being part of the C-terminal EBNA-1).

This study is to analyze whether the primary infection with EBV (leading to IM and antibodies

targeting EBV-derived antigens including antibodies against EBNA-1) leads to an at least

transient occurrence of antibodies against the virus that have the potential to cross-react

with autoantigens as described in patients with systemic autoimmune diseases (e.g. complement

C1q, dsDNA, Ro, Sm, MOG, NF186 and others). The advantage of an analysis of patients with

primary infection is that the de novo synthesis of antibodies against the virus will allow to

determine the time-dependent evolution of the antibody repertoire against the virus as well

as against a number of autoantigens.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Participants fulfilling all of the following inclusion criteria are eligible for the

infectious mononucleosis (IM) group:

- Informed consent as documented by signature

- Confirmed primary EBV infection as confirmed by the treating clinician and defined by:

- Compatible clinical (infectious mononucleosis symptoms including but not limited to

malaise, headache, fever, tonsillitis, pharyngitis, cervical lymph nodes enlargement)

and laboratory picture (lymphocyte count elevation, LUC cells, reactive lymphocytes in

manual differential, elevated liver enzymes; of note, not all typically described

features have to be fulfilled)

AND

- serology compatible with primary EBV infection (anti-EBNA IgG negative, anti-VCA IgG

negative, anti-VCA IgM positive OR anti-EBNA IgG negative, anti-VCA IgG positive,

anti- VCA IgM positive).

Participants fulfilling all of the following inclusion criteria will be eligible for the

control group:

- Informed consent as documented by signature.

- one of the following:

1. Clinical picture of upper respiratory tract infection (including but not limited

to tonsillitis/pharyngitis, malaise, headache, cough, rhinitis, cervical node

enlargement)

2. confirmed primary Cytomegalovirus (CMV) infection (an optimal control group;

however, the number of patients with a diagnosis of primary CMV infection is

limited).

Exclusion Criteria:

- Suspicion/diagnosis of IM as per judgement of the treating clinician (control group

only); this individual may be eligible later for the IM group if primary EBV infection

is confirmed, subsequently.

- Immunosuppression (broadly defined as primary/secondary immunodeficiency or treatment

with an immunosuppressive medication including ≥ 10mg prednisone equivalent).

- History of autoimmune disease (e.g. SLE, vasculitis etc.)

Studien-Rationale

Primary outcome:

1. Change in occurrence of antibodies cross-reacting with autoantigens in patients with primary EBV infection (Time Frame - at Visit 2 (day 1 (+ 1 day)), Visit 3 (3 months +/- 21 days), Visit 4 (6 months +/- 1 month) and Visit 5 (12 months +/-2 months)):
Change in occurrence of antibodies cross-reacting with autoantigens in patients with primary EBV infection compared to a control group.

Secondary outcome:

1. Change in RNA expression profiles of peripheral blood cells (Time Frame - at Visit 2 (day 1 (+ 1 day)), Visit 3 (3 months +/- 21 days), Visit 4 (6 months +/- 1 month) and Visit 5 (12 months +/-2 months)):
Change in RNA expression profiles of peripheral blood cells in patients with primary EBV infection over time and compared to a control group.

2. Change in Fatigue Assessment Scale (FAS) (Time Frame - at month 6 and at month 12):
The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.

3. Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire (Time Frame - at month 6 and at month 12):
FACIT-F is a 13-item instrument designed to assess fatigue/ tiredness and its impact on daily activities and functioning in a number of chronic diseases. The instrument includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning (e.g., sleeping, and social activities). Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so" (in which higher scores represent better functioning or less fatigue).

4. Change in Procalcitonin (PCT) (Substudy Procalcitonin) (Time Frame - on day 1 and day 3 (+/-1 day)):
Change in PCT compared in primary EBV infection patients with different disease severities and different treatment modalities (in particular if they received antibiotics or not), and in comparison to a control group (with mostly (viral) upper respiratory tract infection or primary CMV infection); In IM and control patients admitted to hospital, blood will be collected for PCT measurement

5. Occurrence of acute complications such as PTA or need for tonsillectomy (Time Frame - at Visit 2 (day 1 (+ 1 day)) and Visit 3 (3 months +/- 21 days),):
Occurrence of acute complications such as PTA or need for tonsillectomy in primary EBV infection patients treated with antibiotics in comparison to patients treated without antibiotics

Studien-Arme

patients with confirmed primary EBV infection
40 patients with confirmed primary EBV infection as confirmed by the treating clinician and defined by: - Compatible clinical (infectious mononucleosis symptoms including but not limited to malaise, headache, fever, tonsillitis, pharyngitis, cervical lymph nodes enlargement) and laboratory picture (lymphocyte count elevation, LUC cells, reactive lymphocytes in manual differential, elevated liver enzymes; of note, not all typically described features have to be fulfilled) AND - serology compatible with primary EBV infection (anti-EBNA IgG negative, anti-VCA IgG negative, anti-VCA IgM positive OR anti-EBNA IgG negative, anti-VCA IgG positive, anti- VCA IgM positive)
control patients
40 control patients (Clinical picture of upper respiratory tract infection (including but not limited to tonsillitis/pharyngitis, malaise, headache, cough, rhinitis, cervical node enlargement)) and/ or confirmed primary Cytomegalovirus (CMV) infection

Geprüfte Regime

Data collection: Participant characteristics (Illness course, complications of primary EBV infection and provided treatments):
Data collection: Participant characteristics (Illness course, complications of primary EBV infection and provided treatments) during 12 months (baseline visit and follow-up visits at 3, 6 and 12 months).
Data collection: blood samples (analysed for EBV serology, auto-antibody-testing/biobanking, RNA expression analyses, procalcitonin):
Data collection: blood samples (analysed for EBV serology, auto-antibody-testing/biobanking, RNA expression analyses, procalcitonin) during 12 months (baseline visit and follow-up visits at 3, 6 and 12 months).
Data collection: Patient reported outcome (Fatigue questionnaires):
Data collection: Patient reported outcome (Fatigue questionnaires) at 6 and 12 months.

Quelle: ClinicalTrials.gov

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