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

NCT07536048 | Not Yet Recruiting

• 1 other identifier: VBP00004
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Epstein-Barr Virus (EBV); Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

Healthy participants who are EBV seropositive

Procedure: Investigational Procedure

Interventions

Investigational Procedure PROCEDURE

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

Healthy participants who are EBV seropositive

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 100 EBV seropositive participants aged 18 to 29 years

You may qualify if:

• Participants who are healthy as determined by medical evaluation including medical history and physical examination
• Participants who are EBV seropositive based on serology testing

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

MeSH Terms

Conditions

Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 17, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): May 19, 2027
• Study Completion (Estimated): May 19, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share