Epstein-Barr Virus (EBV), Healthy Volunteers
Conditions
Brief summary
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).
Interventions
PROCEDUREInvestigational Procedure
It consists of prospective blood and saliva collections. Study without any IMP administration.
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 to 29 years on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history and physical examination * Participants who are EBV seropositive based on serology testing
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
Australia
Outcome results
None listed