Investigating antibodies in primary Epstein-Barr virus infection
Occurrence of Antibodies Cross-reacting With Autoantigens in Primary EBV Infection - a Longitudinal, Observational Study
This study is trying to see how antibodies behave in people with a first-time Epstein-Barr virus infection and how it might relate to autoimmune diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Basel) |
| Trial ID | NCT05127980 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the occurrence of antibodies that cross-react with autoantigens in patients experiencing primary Epstein-Barr virus (EBV) infection, compared to a control group. It will establish a biobank for longitudinal analysis of immune responses and inflammatory processes associated with EBV. Substudies will evaluate the effects of antibiotic treatment on primary EBV infection outcomes and measure procalcitonin levels in affected patients. The study focuses on understanding the relationship between EBV infection and the development of systemic autoimmune diseases.
Who should consider this trial
Good fit: Ideal candidates include individuals with confirmed primary EBV infection exhibiting symptoms of infectious mononucleosis.
Not a fit: Patients with chronic EBV infection or those without symptoms of infectious mononucleosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the immune response to EBV and its potential link to autoimmune diseases, leading to better patient management.
How similar studies have performed: While the relationship between EBV and autoimmune diseases has been explored, this specific approach to studying antibody cross-reactivity in primary infection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Basel
- University Hospital Basel, Division of Internal Medicine — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Michael Osthoff, PD Dr. med. — University Hospital Basel, Division of Internal Medicine
- Study coordinator: Michael Osthoff, PD Dr. med.
- Email: michael.osthoff@usb.ch
- Phone: +41 61 328 68 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.