A Longitudinal Study of Epstein-Barr Virus (EBV) Reactivation in Adults Aged 18 to 29 Years

N/ANot Yet RecruitingNCT07536048

Sanofi Pasteur, a Sanofi Company100 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Epstein-Barr Virus (EBV)Healthy Volunteers

Interventions

Investigational ProcedurePROCEDURE

It consists of prospective blood and saliva collections. Study without any IMP administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 29 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of participants with EBV DNA in blood and saliva at each study visit

Time frame: 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

Time frame: 6 or 12 months

Secondary Outcomes

Levels of IgG antibodies binding to EBV antigens, measured at selected time points in a subset of participants

Time frame: 6 or 12 months

Levels of EBV nAbs in serum measured at selected timepoints in a subset of participants

Time frame: 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

Time frame: 6 or 12 months

Central Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610 contact-us@sanofi.com

Data from ClinicalTrials.gov

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