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This multi-center, prospective, longitudinal cohort study is designed to gather immunological and clinical data on EBV reactivation in EBV seropositive adults aged 18 to 29 years.
This study will follow a cohort of approximately 100 EBV seropositive adults 18 to 29 years of age in Australia over a 6 or 12-month period.
Participants will not receive any study intervention (eg, study treatments, vaccines).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy participants who are EBV seropositive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Procedure | Procedure | It consists of prospective blood and saliva collections. Study without any IMP administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with EBV DNA in blood and saliva at each study visit | 6 or 12 months | |
| Serology testing indicative of EBV reactivation, measured by anti-VCA IgG/IgM, anti-EBNA-1 IgG and anti-EA IgG at each study visit | 6 or 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of IgG antibodies binding to EBV antigens, measured at selected time points in a subset of participants | 6 or 12 months | |
| Levels of EBV nAbs in serum measured at selected timepoints in a subset of participants | 6 or 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives, including planning to leave the area of the study before the end of study period
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Approximately 100 EBV seropositive participants aged 18 to 29 years
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Griffith - University Clinical Trial Unit - Site Number : 0360001 | Gold Coast | 4222 | Australia | |||
| University of Sunshine Coast - Site Number : 0360002 |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Immunogenicity assessments at baseline to identify antibody signatures that may correlate with the occurrence of EBV reactivations during study period. Neutralizing and IgG binding assays will be performed in a subset of participants | 6 or 12 months |
| South Brisbane |
| 4101 |
| Australia |
| D014412 |
| Tumor Virus Infections |