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

May 18, 2026 updated by: Sanofi Pasteur, a Sanofi Company

A Multi-center, Prospective, Longitudinal Cohort Study to Collect Immunological and Clinical Data on Epstein-Barr Virus (EBV) Reactivation in EBV Seropositive Male and Female Adults Aged 18 to 29 Years

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Gold Coast, Australia, 4222
        • Griffith - University Clinical Trial UnitSite Number : 0360001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Approximately 100 EBV seropositive participants aged 18 to 29 years

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy participants who are EBV seropositive
Procedure: Investigational Procedure
It consists of prospective blood and saliva collections. Study without any IMP administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with EBV DNA in blood and saliva at each study visit
Time Frame: 6 or 12 months
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
6 or 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Levels of IgG antibodies binding to EBV antigens, measured at selected time points in a subset of participants
Time Frame: 6 or 12 months
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
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
6 or 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

May 19, 2027

Study Completion (Estimated)

May 19, 2027

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBP00004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on Investigational Procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe